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Malaria control in emergenciesField manualMalaria control in emergenciesField manualMalaria control in emergencies:field manualISBN 978-92-4-011283-4(electronic version)ISBN 978-92-4-011284-1(print version)World Health Organization 2025Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy of this translation.The original English edition shall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization(http:/www.wipo.int/amc/en/mediation/rules/).Suggested citation.Malaria control in emergencies:field manual.Geneva:World Health Organization;2025.Licence:CC BY-NC-SA 3.0 IGO.Cataloguing-in-Publication(CIP)data.CIP data are available at https:/iris.who.int/.Sales,rights and licensing.To purchase WHO publications,see https:/www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing,see https:/www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables,figures or images,it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder.The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.Design and layout by rec design.iiiContentsAcknowledgements ixAbbreviations xiForeword xiiGlossary xiiiIntroduction 1Chapter 1.Malaria epidemiology and control in emergencies 41.1 Overview 41.2 Introduction to humanitarian emergencies 41.2.1 Definition and scope 41.2.2 Types and phases 51.3 Malaria epidemiology 61.3.1 Malaria,where it occurs and who is affected 61.3.2 Signs and symptoms of malaria 81.3.3 Altitude,temperature,rainfall,seasonality and climate change 91.3.4 Immunity against malaria 111.3.5 Transmission potential of different vector species 121.4 Malaria in emergencies 121.4.1 Malaria epidemics in non-emergency situations 141.4.2 Malaria in humanitarian emergencies in moderate to high transmission settings (non-epidemic)151.4.3 Malaria epidemics in humanitarian emergencies 151.4.4 Malaria in the context of other public health emergencies 181.5 Conducting a malaria risk assessment 191.5.1 Case management 231.5.2 Chemoprevention 241.5.3 Vector control 26Chapter 2.Coordination 282.1 Overview 282.2 Coordination mechanisms for malaria in emergency settings 282.2.1 United Nations-led coordination mechanisms 28Malaria control in emergencies:field manualiv2.2.2 Government-led public health emergency coordination structures and mechanisms 322.2.3 Health Cluster Emergency coordination between United Nations and country-level mechanisms 352.3 Planning and implementation of malaria control in emergency 352.4 Finance and administration for the malaria response 382.4.1 Funding mechanisms 382.5 Operations support,logistics and human resources 402.5.1 General procurement 402.5.2 Safety and security 412.5.3 Logistics plan 422.5.4 Human resources 43Chapter 3.Diagnostics and case management 463.1 Overview 463.2 Initial assessment:triage of danger signs and clinical features of uncomplicated and severe malaria 473.2.1 Danger signs 473.2.2 Clinical features of uncomplicated and severe malaria 473.2.3 Specific notes for emergencies 483.3 Confirmatory testing 483.3.1 Initial malaria risk assessment for guiding the case management algorithm 483.3.2 Rapid diagnostic tests for confirmatory testing 493.3.3 Role of light microscopy 503.4 Case management uncomplicated malaria(all species)513.4.1 Optional additional treatment in management of uncomplicated malaria 513.4.2 Treatment failure 523.5 Case management severe malaria 533.5.1 Pre-referral treatment when severe malaria is suspected/danger signs are present 533.5.2 Treatment of severe malaria in a health facility 543.5.3 Complications of severe malaria 553.6 Vulnerable groups 573.6.1 Children under 5 kg 573.6.2 Pregnant women 58v3.6.3 Malnourished persons 583.6.4 People living with HIV 583.7 Operationalizing malaria case management in emergency situations 593.8 Monitoring and evaluation of case management 62Chapter 4.Chemoprevention 644.1 Overview 644.2 Mass drug administration 654.2.1 Mass drug administration in P.falciparum contexts 684.2.2 Mass drug administration in P.vivax contexts 684.3 Targeted drug administration 684.4 Intermittent preventive treatment for pregnant women 694.5 Perennial malaria chemoprevention 704.6 Seasonal malaria chemoprevention 714.7 Intermittent preventive treatment for school-aged children 724.8 Post-discharge malaria chemoprevention 734.9 Monitoring and evaluation of chemoprevention 73Chapter 5.Vector control 765.1 Overview 765.2 Operationalizing vector control 775.2.1 Joint assessments for vector control 795.2.2 Logistic considerations for IRS and ITNs 805.2.3 Insecticide resistance in choosing effective vector control tools 805.3 Insecticide-treated nets 815.3.1 Practical information 825.3.2 Planning and procurement 835.3.3 Distribution and coverage 855.4 Indoor residual spraying 875.4.1 Practical information 885.4.2 Planning and procurement 905.4.3 Distribution and coverage 91Malaria control in emergencies:field manualvi5.5 Larval source management 935.5.1 Practical information 935.5.2 Planning and procurement 945.5.3 Distribution and coverage 945.6 Other vector control tools that may be applicable in emergency settings 955.6.1 Spatial repellents(passive emanators and mosquito coils)955.6.2 Non-mesh insecticide impregnated net 965.6.3 Attractive targeted sugar baits 965.6.4 Topical repellents 975.6.5 Insecticide-treated clothing and other materials 975.6.6 Treatment of domestic animals 975.7 Monitoring and evaluation of vector control 985.7.1 Entomological monitoring 99Chapter 6.Risk communication and community engagement 1016.1 Overview 1016.2 Key information for communities 1026.3 Community engagement,empowerment and participation 1026.4 Key principles for working with communities 1056.5 Health communication plan 1076.6 Communication channels,messages and methods 1076.6.1 Communication channels 1086.6.2 Malaria messages 1086.6.3 Communication delivery methods 1096.7 Monitoring and evaluation 1096.7.1 Risk communication and community engagement indicators 110Chapter 7.Operational research 1127.1 Overview 1127.2 Considerations for research in emergency settings 1147.2 Diagnosis 1147.3 Treatment 115vii7.4 Prevention 1167.4.1 Seasonal malaria chemoprevention 1187.5 Expanded vector control tools 1187.5.1 Passive emanators(spatial repellents)1187.5.2 Topical repellents 1197.5.3 Attractive targeted sugar baits 1197.5.4 Insecticide-treated textiles 1207.5.5 Treatment of domestic animals 1207.6 Vaccines 120Chapter 8.Surveillance and monitoring and evaluation 1228.1 Overview 1228.2 Public health situation analyses 1238.2.1 Malaria-specific assessments and evaluations 1248.2.2 Cluster evaluations 1258.3 Malaria surveillance 1268.3.1 Analysis of indicators 1268.3.2 Establishing surveillance systems in humanitarian emergencies 1288.3.3 Monitoring and reporting of trends 1288.3.4 Early outbreak detection 1298.4 Monitoring and evaluation 130References 131Annex 1.WHO Emergency Response Framework and Protracted Emergency Framework 139Annex 2.Costing templates 142Annex 3.Considerations for deployment of vector control interventions in humanitarian emergency settings 143Annex 4.Entomological assessment and monitoring for humanitarian emergencies 145Annex 5.Malaria surveillance indicators 149Malaria control in emergencies:field manualviiiCase studiesCase study 1.Responding to malaria upsurges during the Ebola outbreak in Uganda,September 2022 to January 2023 25Case study 2.Malaria emergency response post Cyclone Idai,Mozambique 34Case study 3.Management of severe febrile illness in vulnerable populations in Central African Republic,civil war context 54Case study 4.Malaria outbreak experience by MSF in North Darfur,Sudan,in 2019 56Case study 5.Mass drug administration and ITN distributions in the epicentre of an Ebola outbreak in Beni,North Kivu,Democratic Republic of the Congo 67Case study 6.Seasonal malaria chemoprevention implementation among IDPs in Borno State,Nigeria 72Case study 7.Insecticide-treated net distribution in North-West Region,Cameroon 87Case study 8.Indoor residual spraying in Maban County,South Sudan 92Case study 9.Community management of malaria in Uganda refugee settlements 104Case study 10.Use of malaria RDTs by community health services in Afghanistan 115Case study 11.Passive emanator deployment in Puerto Rico to address dengue emergency 119Case study 12.Implementing an EWARS to improve detection and reporting of malaria in northern Nigeria 2014 129ixAcknowledgementsThe World Health Organization(WHO)gratefully acknowledges the many individuals who contributed to the development of this field manual.From the WHO Global Malaria Programme,Maru Aregawi(Unit Head,High Burden to High Impact)served as lead author,coordinated the manuals development and edited all chapters.His predecessor,Leonard Ortega,supervised and coordinated the foundational work that informed this manuals development.Stefan Hoyer made significant contributions by drafting and leading the technical updates for many of the chapters.Peter Olumese and Andrea Bosman reviewed and edited Chapters 3,4 and 7,while Jan Kolaczinski,Emmanuel Chanda and Seth Irish,with the support of Tessa Knox(Independent Consultant),reviewed and edited Chapter 5 as well as vector control-related content in Chapter 7,and Mary Hamel reviewed all malaria vaccine-related content ensuring the contents are aligned with the WHO guidelines for malaria.Daniel Ngamije provided oversight and technical guidance,and reviewed the final version of the document.WHO also extends its thanks to the members of the Working Group on Malaria Control in Humanitarian Emergencies,which was established to review the field manual,for their significant contributions to the technical content and for providing input on the latest practical lessons and case studies from the field.In addition to the WHO staff members acknowledged above,the following members of the Working Group contributed to the content of the following chapters:Chapter 1:Stephan Hoyer(WHO Global Malaria Programme),Ida-Marie Ameda(United Nations Childrens Fund;UNICEF),Allen Maina(Office of the United Nations High Commissioner for Refugees;UNHCR),Mire Connolly(School of Health Sciences,University of Galway,Ireland),Richard Allan(MENTOR Initiative,United Kingdom of Great Britain and Northern Ireland)and Ghasem Zamani(WHO Regional Office for the Eastern Mediterranean),and Maru Aregawi(WHO Global Malaria Programme).Chapter 2:Ida-Marie Ameda(UNICEF),Allen Maina(UNHCR)and Sophie Maes(WHO Health Emergencies Programme).Chapter 3:Bhargavi Rao(Mdecins sans Frontires,Kingdom of the Netherlands,and London School of Hygiene and Tropical Medicine,United Kingdom of Great Britain and Northern Ireland),Charles Delacollete(Independent Consultant),Harriet Pasquale(Ministry of Health,South Sudan)and Ghasem Zamani(WHO Regional Office for the Eastern Mediterranean),and Peter Olumese(WHO Global Malaria Programme).Chapter 4:Estrella Lasry(Global Fund to Fight AIDS,Tuberculosis and Malaria)and Peter Olumese(WHO Global Malaria Programme).Chapter 5:Joseph Lewinski(Independent Consultant,United States of America),Michael Macdonald(Independent Consultant),Marc Rowland(London School of Hygiene and Tropical Medicine,United Kingdom of Great Britain and Northern Ireland),Natacha Protopopoff(London School of Hygiene and Tropical Medicine,United Kingdom of Great Britain and Northern Ireland),Richard Allan(MENTOR Initiative,United Kingdom of Great Britain and Northern Ireland),Tessa Knox(WHO consultant)and Seth Irish(WHO Global Malaria Programme).Malaria control in emergencies:field manualxChapter 6:Marc Rowland(London School of Hygiene and Tropical Medicine,United Kingdom of Great Britain and Northern Ireland).Chapter 7:Ida-Marie Ameda(UNICEF),Allen Maina(UNHCR)and Sandra Harlass(UNHCR).Chapter 8:Molly Robertson(Global Fund to Fight AIDS,Tuberculosis and Malaria),Geoffrey Namara(WHO Hub for Pandemic and Epidemic Intelligence),and Maru Aregawi(WHO Global Malaria Programme).WHO is grateful to the following people who,drawing on their long experience with malaria control in humanitarian emergencies,contributed to multiple iterations of the draft manual:Antoinette Eleonore Ba(UNICEF),Valentina Buj de Lauwerier(UNICEF),Jorge Castilla(WHO),the late Martin De Smet(Mdecins Sans Frontires,Belgium),Manuel Garca-Herranz(UNICEF),Elkhan Gasimov(WHO),Michelle Gayer(International Rescue Committee),Heiko Hering(UNHCR),Natasha Howard(London School of Hygiene and Tropical Medicine,United Kingdom of Great Britain and Northern Ireland,and Saw Swee Hock School of Public Health,Singapore),Charles Nelson Kakaire(UNICEF),Karin Kllander(UNICEF),Guilhem Labadie(UNICEF),Ken Limwame(UNICEF),Daniel Lopez-Acuna(Andalusian School of Public Health,Spain),Peter Maes(Mdecins Sans Frontires,Belgium),Elevanie Nyakensha(UNICEF),Patrick Okello(Global Fund to Fight AIDS,Tuberculosis and Malaria),Abderrahmane Tfeil(WHO,Cte dIvoire),John Thomas(UNICEF),David Townes(Bureau for Humanitarian Assistance,United States Agency for International Development),Naqibullah Safi(UNICEF)and Raman Velayudhan(WHO).WHO would like to thank the following people from national malaria control programmes and United Nations organizations from malaria endemic countries affected by conflict who contributed to the development of this handbook:Mohammad Sami Nahzat(Ministry of Public Health,Afghanistan),Naim Safi(WHO Country Office,Afghanistan),Musondoli Kayisavera Demson(Ministry of Public Health,Democratic Republic of the Congo),Thirry Kazadi(UNICEF,Democratic Republic of the Congo),Bacary Sambou(WHO Country Office,Democratic Republic of the Congo,Independent Consultant,Senegal),Samira Al-Eryani(WHO Regional Office for the Eastern Mediterranean),Germain Rakotozafy(Ministry of Public Health,Madagascar),Hasina Harinjaka Ramiandrisoa(Ministry of Public Health,Madagascar),Brune Estelle Ramiranirina(Ministry of Public Health,Madagascar),Omga Raobela(Ministry of Public Health,Madagascar),Linda Ozor(WHO Country Office,Nigeria),Jamal Aan(WHO Country Office,Somalia),Farhana Zuberi(UNICEF,Somalia),Ali Abdirahman Osman(Ministry of Health,Somalia),Joy Kenyi(UNICEF,South Sudan),Adel Ajasirlur(WHO Country Office,Yemen),Tarek Sultan Saleh Bin Hawail(Ministry of Public Health and Population,Yemen)and Methaq Abdullah Al-Ssada(Ministry of Public Health and Population,Yemen).WHO wishes to express appreciation to John Haskew for his review and editing an earlier version of the manual,to Joseph Lewinski for his support in coordinating the finalization of the publication,and to Xiao-Nong Zhou,Vice Dean of the School of Global Health at Shanghai Jiao Tong University and Chief Scientist at the Chinese Center for Disease Control and Prevention,for his comprehensive expert review of the manual.Funding for the final review and production of the manual was generously provided by the Gates Foundation.xiAbbreviationsACTartemisinin-based combination therapyALartemether-lumefantrineAQamodiaquineASartesunateASMQartesunate-mefloquineASPYartesunate-pyronaridineATSBattractive targeted sugar baitsCHWcommunity health workerCQchloroquineDHAPQdihydroartemisinin-piperaquineEWARSEarly Warning,Alert and Response SystemGISgeographic information systems HRP2/3histidine-rich protein II or IIIIASCInter-Agency Standing CommitteeiCCMintegrated community case managementIDPinternally displaced personsIRSindoor residual sprayingITNinsecticide-treated netIVintravenousLSMlarval source managementMDAmass drug administrationMSFMdecins Sans FrontiresNGOnongovernmental organizationsNMCPnational malaria control programmesOCHAUnited Nations Office for the Coordination of Humanitarian AffairsPDMCpost-discharge malaria chemopreventionpLDHPlasmodium lactate dehydrogenasePMCperennial malaria chemopreventionRDTrapid diagnostic testSAMsevere acute malnutritionSMCseasonal malaria chemopreventionSPsulfadoxine-pyrimethamineTDAtargeted drug administrationUNHCROffice of the United Nations High Commissioner for RefugeesUNICEFUnited Nations Childrens FundWASHwater,sanitation and hygieneWHOWorld Health OrganizationMalaria control in emergencies:field manualxiiForewordOur world is grappling with a complex convergence of crises from conflict and climate-induced shocks to wide-scale displacement placing millions of lives in peril and straining the systems designed to support them.Communities uprooted from their homes are among the hardest hit,often left to face both insecurity and heightened exposure to disease including malaria.A record 117 million people were displaced across the globe by the end of 2023,including nearly 80 million living in 43 malaria-endemic countries.These staggering figures reflect a rapidly shifting global landscape in which health systems are under growing pressure and response capacity is stretched thin.Displaced populations often have no choice but to live in overcrowded settlements,with health systems disrupted or no longer functioning.In such fragile settings,people are more vulnerable to malaria and other health conditions,while having little or no access to health services for prevention and treatment.And yet,even in crisis settings,timely and coordinated action can transform health outcomes.When malaria interventions are embedded early in humanitarian operations,they help prevent illness,ease suffering,and save lives.This updated field manual,Malaria control in emergencies,offers critical guidance for those working on the front lines of crisis.Grounded in real-world experience from more than 24 countries and shaped by the expertise of local and global partners,it provides practical tools for mounting swift and effective responses to malaria in complex emergency settings.At its core,this manual is a call to action:to strengthen collaboration,uphold the right to health,and to ensure that no one is left behind even in the most difficult of circumstances.Dr Tedros Adhanom GhebreyesusDirector-GeneralWorld Health OrganizationxiiiGlossaryThe glossary definitions were systematically developed through a thorough verification and adaptation process.This process built on previous versions of the manual(formerly known as the handbook)to maintain consistency,incorporated relevant UN agency references to align with humanitarian standards,and referenced WHO malaria terminology as the technical foundation.Additionally,terms were customized to reflect the manuals emergency-specific context.While only one glossary term currently includes a direct citation,all definitions underwent this rigorous review to ensure accuracy and relevance for malaria control in emergency settings.Aacute emergency A sudden-onset crisis that requires immediate humanitarian response due to life-threatening conditions,such as natural disasters(earthquakes,floods,cyclones)or sudden outbreaks of conflict or disease.These emergencies typically overwhelm local response capacities and necessitate urgent external assistance.adherence(compliance)Health-related behaviour that abides by the recommendations of a doctor or other health care provider.anaemia A reduction in the quantity of the oxygen-carrying pigment haemoglobin in the blood.The main symptoms are tiredness,breathlessness on exertion,pallor and poor resistance to infection.Anopheles A genus of widely distributed mosquitoes,occurring in tropical and temperate regions and containing some 400 species.Malaria parasites(Plasmodium species)are transmitted to humans through the bite of female Anopheles mosquitoes.artemisinin-based combination therapy A combination of an artemisinin derivative with a longer-acting antimalaria drug that has a different mode of action.asymptomatic Not showing any symptoms of disease,whether disease is present or not.(See parasitaemia for“asymptomatic malaria”.)Bbreeding site(place)See larval habitat.Ccase A person who has the disease,health disorder or condition that meets the case definition.case definition A set of diagnostic criteria that must be fulfilled for an individual to be regarded as a“case”of a particular disease for surveillance and outbreak investigation purposes.Case definitions can also be based on clinical criteria,laboratory criteria or a combination of the two.Malaria control in emergencies:field manualxivcase fatality rate The proportion of individuals diagnosed with a particular disease(ex.malaria)who die from that disease(ex.malaria)over a specified period of time.(usually expressed as a percentage).chemoprevention Administration of antimalarial drugs to prevent or delay the development of an infection(ex.seasonal malaria chemoprevention).chemoprophylaxis Administration of antimalaria drugs to prevent malaria in travels to prevent either the development of an infection or the progression of an infection to a disease.(ex.mefloquine for travellers)clinical malaria malaria with observable symptoms combined with laboratory confirmation of Plasmodium infection and prompts a person to seek medical munity empowerment The process by which community members gain control over decisions shaping their lives;for example,by building capacity,developing partnerships and networks and gaining a voice to advocate for themselves.Effective humanitarian response must include community empowerment and capacity-munity health worker A member of the community who is integrated into primary health care programmes after a short period of training on health-related issues,and who acts as an intermediary between the community and the health services.Community health workers may be paid staff or plex emergency A humanitarian emergency in a country,region or society where there is a total or considerable breakdown of authority resulting from conflict,and that requires an international response that goes beyond the mandate or capacity of any single agency,and that the Inter-Agency Standing Committee(IASC)assesses requires intensive and extensive political advocacy and coordination(1).Such emergencies have a devastating effect on children and women in particular and call for a complex range of responses.contact(of an infection)In the context of malaria,contact means human contact with an infected female Anopheles mosquito.coverage A measure of the extent to which services cover the potential need for these services in a community.It is expressed as a proportion in which the numerator is the number of services rendered and the denominator is the number of instances in which the service should have been rendered.Eeffectiveness A measure of the extent to which a specific intervention,procedure,regimen or service,when deployed in the field in routine circumstances,does what it is intended to do for a specified population;a measure of the extent to which a health care intervention fulfils its objectives.efficacy The extent to which a specific intervention,procedure,regimen or service produces a beneficial result under ideal conditions;the benefit or utility being to the individual or population receiving the service,treatment regimen or intervention.Ideally,the determination of efficacy is based on the results of a randomized controlled trial.xvendemic Term applied to malaria when there is a constant measurable incidence of both cases and natural transmission in an area over a number of years.epidemic Term applied to malaria when the incidence of cases in an area rises rapidly and markedly above its usual(or seasonal)level(including when infections occur in an area where malaria was not previously present).Hhaemolytic anaemia A disorder in which red blood cells are destroyed faster than they can be made.The destruction of red blood cells is called haemolysis.health communication Activity that informs at-risk individuals and communities about positive health-related behaviour changes that could reduce their risk(e.g.their risk of malaria infection)and improve their management of illness.health education Any combination of learning experiences designed to help individuals and communities improve their health by increasing their knowledge or influencing their attitudes and behaviours.Effective health education includes interaction,participation and critical analysis.health literacy The cognitive and social skills that determine the motivation and ability of individuals to gain access to,understand and use information in ways that promote and maintain good health.For an effective emergency response,community engagement efforts should recognize how power relations affect access to information and the ability to use that information,and should include interventions to address the barriers.host(epidemiology)In an epidemiological context,the host is the individual,population or group harbouring or providing subsistence to a parasite.Biological,social and behavioural characteristics of this group that are relevant to health are called“host factors”.host community A community that hosts refugees or internally displaced persons,whether in settlements,integrated into households or independently.household One or more persons who occupy a dwelling.The persons may or may not be a family.The term“household”is also used to describe the dwelling unit in which the persons live.humanitarian emergency A situation in which the functioning of a community or society is severely disrupted,causing suffering and losses that exceed the affected populations ability to cope using its own resources.Humanitarian emergencies can be caused by instability,conflict or natural disasters.Humanitarian emergencies commonly involve population displacement,food insecurity and malnutrition,and health systems disruptions that cause excess mortality and morbidity in affected populations.Malaria control in emergencies:field manualxviIimmunity,acquired Resistance acquired by a host as a result of previous exposure to malaria infection.incidence rate The rate at which new events occur in a population.The numerator is the number of new events that occur in a defined period and the denominator is the population at risk of experiencing these events during this period,sometimes expressed as person-time.infection,mixed Malaria infection with more than one species of Plasmodium.informed consent Voluntary consent given by a subject(i.e.a person or a responsible proxy such as a parent)for participation in a study,immunization programme,treatment regimen,etc.,after being informed of the purpose,methods,procedures,benefits and risks,and,when relevant,degree of uncertainty about outcomes.The essential criteria of informed consent are that the subject has both knowledge and comprehension,that consent is freely given without duress or undue influence,and that the right of withdrawal at any time is clearly communicated to the subject.Kknowledge,attitudes,practice survey A formal survey,using face-to-face interviews,in which people are asked standardized pretested questions dealing with their knowledge,attitudes and practice concerning a given health or health-related problem.Llarge-scale pilot implementation A process of testing a new intervention in a broader context after initial small-scale trials have been completed.Large-scale pilot implementation typically involves deploying the project in a real-world environment across multiple sites or with a significant population to gather data,assess feasibility and evaluate effectiveness on a larger scale before a policy is made and full-scale rollout is conducted.larva The pre-adult or immature stage hatching from a mosquito egg.larval habitat Site where mosquitoes lay their eggs,or where their larvae or pupae are found.(Also known as“breeding site”.)larval source management The management of aquatic habitats(water bodies)that are potential larval habitats for mosquitoes,in order to prevent the completion of development of the immature stages.There are four types of larval source management:1.habitat modification:a permanent alteration to the environment;2.habitat manipulation:a recurrent activity;3.larviciding:the regular application of biological or chemical insecticides to water bodies;4.biological control:the introduction of natural predators into water bodies.xviiMmobile clinic A mobile clinic is a customized motor vehicle that travels to communities to provide health care.Mobile clinics deliver a wide variety of health services and may be staffed by a combination of physicians,nurses,community health workers and other health professionals.They can include customized vehicles,motorbikes,boats or rickshaws.morbidity Having a specific disease or condition.Morbidity is usually measured by incidence(persons who become ill)or prevalence(persons who are ill)within a population.morbidity rate An estimate of the proportion of a population that becomes ill during a specified period.The numerator is the number of persons who become ill during the period and the denominator is the total number of the population,usually estimated as the mid-year population.mortality rate An estimate of the proportion of a population that dies during a specified period.The numerator is the number of persons who die during the period and the denominator is the total number of the population,usually estimated as the mid-year population.Nneeds assessment A systematic procedure for determining the nature and extent of problems that directly or indirectly affect the health of a specified population.Needs assessment makes use of epidemiological,sociodemographic and qualitative methods to describe health problems and their environmental,social,economic and behavioural determinants.The aim is to identify unmet health care needs and make recommendations about ways to address these needs.Ooutreach(clinic,team)The extending of services or assistance beyond fixed facilities,mainly to ensure access for underserved communities.Outreaches may be offered by health workers via a fixed site or mobile clinics.Pparasitaemia Condition in which malaria parasites are present in the blood.If this condition in the human subject is not accompanied by fever or other symptoms of malaria except for a possible enlargement of the spleen,it is known as asymptomatic parasitaemia,and the person exhibiting the condition is known as an asymptomatic parasite carrier.passive emanator A device that passively emits volatile chemicals,currently pyrethroids,that reduce malaria transmission by killing or repelling mosquitoes or interrupting their feeding cycle.Also known as a spatial repellent.Plasmodium A genus of parasitic protozoa that causes malaria in humans and other animals.It is transmitted to humans through the bites of infected female Anopheles mosquitoes from four specific the species P.falciparum,P.vivax,P.ovale,P.malariae,P.knowlesi.Malaria control in emergencies:field manualxviiiprevention The concept of prevention is best defined in the context of levels,called primary,secondary and tertiary prevention.In epidemiological terms,primary prevention aims to reduce the incidence of disease;secondary prevention aims to reduce the prevalence of disease by shortening its duration;and tertiary prevention aims to reduce the number and/or impact of complications.protracted emergency A crisis that persists over an extended period,often characterized by recurrent or continuous humanitarian needs due to prolonged conflict,displacement,food insecurity,or weak governance.These emergencies require sustained humanitarian support alongside long-term development efforts to build resilience and reduce dependency on aid.protection(humanitarian)Activities aimed at obtaining full respect for the rights of the individual in accordance with the letter and spirit of human rights,refugee and international humanitarian law.Protection involves creating an environment that is respectful to human beings,prevents and/or alleviates the immediate effects of a specific pattern of abuse,and restores dignified conditions of life through reparation,restitution and rehabilitation(2).protection(infection)The use of preventive strategies and measures intended to reduce the risk of infection.public health event Any event that may have negative consequences for human health.The term includes events that have not yet led to disease in humans but have the potential to cause human disease through exposure to infected or contaminated food,water,animals,manufactured products or environments.pulmonary oedema Swelling caused by an excess of fluid associated with or affecting the lungs.Rrecrudescence Repeated manifestation of an infection after a period of latency following the primary attack.It is used particularly in the context of treatment failure of P.falciparum,often the result of non-completion of the recommended treatment regimen(especially with short-acting drugs such as quinine and artemisinins),poor efficacy of antimalarials,resistance of parasites to antimalarials,or persistence of subclinical infection in immunocompromised individuals.refugee A person who meets the eligibility criteria under the applicable refugee definition,as provided for in international or regional instruments,under the mandate of the Office of the United Nations High Commissioner for Refugees(UNHCR)and in national legislation.relapse Renewed manifestation(of clinical symptoms and/or parasitaemia)of malaria infection separated from previous manifestations of the same infection by an interval greater than that related to the normal periodicity of the episodes.The term is used mainly for renewed manifestation due to survival of exoerythrocytic forms of P.vivax or P.ovale.xixreservoir(of infection)Any person,animal,arthropod,plant,soil or substance,or combination of these,in which an infectious agent normally lives and multiplies,on which it depends primarily for survival,and where it reproduces itself in such a manner that it can be transmitted to a susceptible host.Includes the natural habitat of the infectious agent.resistance Ability of a parasite strain to multiply or to survive in the presence of concentrations of a drug that normally destroy parasites of the same species or prevent their multiplication.Ability in a population of insects to tolerate doses of an insecticide that would prove lethal to most individuals in a normal population of the same species.Resistance develops as a result of selection pressure.retention(with respect to insecticide-treated nets)An indicator used to establish whether insecticide-treated nets remain with the individuals to whom they were originally distributed.Retention alone is not an indicator of the correct use of insecticide-treated nets.risk The probability that an event will occur;for example,that an individual will become ill or die within a stated period or by a certain age.Also,a nontechnical term that encompasses a variety of measures of the probability of a(generally)unfavourable outcome.risk communication The real-time sharing of information,advice and opinions among experts,community leaders,officials and the people at risk.Risk communication conducted before,during and after an emergency is called emergency risk communication.Ssample A selected subset of a population.A sample may be random or non-random and may be representative or non-representative.sensitivity(of a screening test)The proportion of diseased persons in the screened population who are identified as diseased by the screening test.Sensitivity is a measure of the probability of correctly diagnosing a case,or the probability that the test will identify any given case.See also specificity.social and behaviour change communication A package of communication strategies and approaches aimed at changing specific behaviours and social norms among target groups.social mobilization A process to engage a broad range of traditional,community,civil society and opinion leaders around a common cause or issue,involving reaching out to a broad range of stakeholders(e.g.nongovernmental organizations,professional networks,youth groups,womens groups,community-based organizations,faith-based organizations,professional networks and the private sector)to catalyse them to act.specificity(of a screening test)The ability of a test to designate an individual who does not have a disease as negative.A highly specific test is one that results in few false positive results.Malaria control in emergencies:field manualxxsurveillance The continuous process of systematic collection,orderly consolidation and evaluation of pertinent data with prompt dissemination of the results to those who need to know,particularly those who can take action.survey An investigation in which information is systematically collected;usually carried out in a sample of a defined population group,within a defined time period.Unlike surveillance,a survey is not continuous;however,if repeated regularly,surveys can form the basis of a surveillance system.Ttransmission Any mechanism by which an infectious agent is spread from a source or reservoir to another person.May be perennial or seasonal.Vvector Any insect or living carrier that transports an infectious agent from an infected individual or the individuals waste to a susceptible individual or the individuals food or immediate surroundings.The organism may or may not pass through a developmental cycle within the vector.vector control Measures of any kind directed against a vector of disease and intended to limit its ability to transmit the disease.vulnerability Defencelessness,insecurity,exposure to risks,shock and stress,and having difficulty coping with them.The potential that when something destructive happens or goes wrong,people will not be able to handle the consequences by themselves and the ability to sustain life is endangered.References1.Definition of complex emergency.Geneva:Inter-Agency Standing Committee;1994(https:/interagencystandingcommittee.org/content/definition-complex-emergency).2.Inter-Agency Standing Committee policy on protection in humanitarian action.New York:Inter-Agency Standing Committee;2016(https:/interagencystandingcommittee.org/iasc-protection-priority-global-protection-cluster/iasc-policy-protection-humanitarian-action-2016).1IntroductionGrowing emergencies and displacements across the world demand increasingly complex interventions and responses.The World Health Organization(WHO)has developed Malaria control in emergencies:a field manual to provide technical guidance to help partners respond effectively to malaria in emergency situations.This field manual supersedes the 2013 WHO handbook.Development of the manual involved gathering evidence and practical solutions,the coordination of multiple agencies,extensive consultation with partners and many rounds of review,including extensive input from the Working Group on Malaria Control in Humanitarian Emergencies and other malaria experts.This handbook serves as a comprehensive resource that consolidates consensus on the core elements and key content for malaria interventions in humanitarian emergency and post-emergency contexts.It is grounded in current WHO recommendations and incorporates best practices,lessons learned,and practical solutions to address the main challenges in malaria management during crises.The manual also highlights the ongoing nature of research and innovation in malaria control,ensuring that users have access to the most up-to-date guidance.It includes suggestions for further reading,useful tools and resources,and links to current information,making it an essential tool for humanitarian actors,health workers,and decision-makers operating in emergency settings.The world is facing grave humanitarian emergencies in increasing numbers and of longer durations than ever before.The Office of the United Nations High Commissioner for Refugees(UNHCR)estimates that at the end of April 2024 there were more than 120 million forcibly displaced persons(1).The average period of displacement ranges from 10 to 26 years(2).In addition,natural disasters are becoming more frequent and catastrophic because of extreme weather events caused by climate change and aggravated by environmental degradation.Conflicts have become more protracted than ever.These emergencies often lead to population displacements,food insecurity and negative impacts on health.Displaced populations that have little previous exposure to malaria have no immunity.This is especially true for people who have lived in highlands that are too cold for malaria parasites or in arid areas with few mosquitoes.These populations experience malaria outbreaks if they move to or transit through high transmission zones,such as lower-lying or wetter areas.Malaria outbreaks can also occur when populations from high transmission areas with asymptomatic malaria move to communities that have no immunity.Malaria epidemics can occur in former high transmission areas if control activities are not maintained or if control interventions are disrupted(e.g.because of conflict,natural disasters or large-scale public health emergencies).Floods lead to favourable conditions for malaria outbreaks because the stagnant flood-waters left in their aftermath create and expand larval habitat,enabling prolific vector breeding and enormous increases in vector density.A partial or total collapse of the health system may occur in the early stages of humanitarian emergencies.The presence of malaria should be considered potentially life-threatening because,even in the absence of outbreaks or any notable increase in incidence,malaria often becomes the major cause of death within the context of humanitarian emergencies.Malaria control in emergencies:field manual2Despite the challenges to implementing malaria control in emergencies,many opportunities exist to leverage coordinated support(infrastructure,human resources and others)through the humanitarian response system.As much as possible,malaria control activities should be integrated into the broader humanitarian response.Opportunities for integration include larval source management(LSM)within water,sanitation and hygiene(WASH)activities,the distribution of insecticide-treated nets(ITNs)by the health sector,and indoor residual spraying(IRS)through shelter cluster/sector activities.Each chapter of this manual provides essential guidance on key aspects of malaria control in emergency settings,including epidemiology,coordination,diagnostics,case management,chemoprevention,vector control,risk communication,operational research,and surveillance.The manual consolidates WHO recommendations,practical solutions,and best practices to support effective malaria response during humanitarian emergencies.Chapter 1.Malaria epidemiology and control in emergencies outlines the nature of humanitarian emergencies,malaria epidemiology,and risk factors(e.g.,climate,immunity,and vector species).It highlights the challenges posed by malaria outbreaks during emergencies and presents a summary of core malaria control interventions,including case management,vector control,and chemoprevention.Chapter 2.Coordination emphasizes the importance of coordination among United Nations agencies,government bodies,and emergency response partners.It provides guidance on planning and implementing malaria responses,funding mechanisms,procurement,logistics,and human resource considerations to streamline emergency malaria interventions.Chapter 3.Diagnostics and case management focuses on assessing and managing uncomplicated and severe malaria in emergencies.It details danger signs,use of rapid diagnostic tests(RDTs),treatment protocols,pre-referral care,and the management of severe malaria complications.Special considerations for vulnerable groups(e.g.,children,pregnant women,and people living with HIV)are included,along with monitoring and evaluation(M&E)indicators for case management.Chapter 4.Chemoprevention outlines the use of drugs to prevent malaria infections,covering mass drug administration(MDA),seasonal malaria chemoprevention(SMC),intermittent preventive treatment(IPT)for pregnant women and school-aged children,and post-discharge chemoprevention for vulnerable groups in emergency settings.The chapter highlights planning,implementation,and monitoring and evaluation of chemoprevention programs.Chapter 5.Vector control presents key approaches to vector control,including insecticide-treated nets(ITNs),indoor residual spraying(IRS),and larval source management(LSM).It discusses operational planning,procurement,distribution,and entomological monitoring.It also introduces emerging vector control tools,such as spatial repellents,insecticide-treated clothing,and attractive targeted sugar baits(ATSBs),that may be useful in emergency settingsChapter 6.Risk communication and community engagement(RCCE)highlights how to effectively engage and inform communities about malaria risks and control measures.It focuses on developing communication plans,community participation,and messaging strategies,using appropriate communication channels.The chapter also emphasizes monitoring and evaluation of RCCE activities to ensure effective messaging.3Chapter 7.Operational research supports continuous improvement in malaria control strategies.It explores areas for research on diagnostics,treatment,prevention,and new vector control tools(like spatial repellents and insecticide-treated textiles)and highlights the need for vaccine research.The chapter provides guidance on operational research design and implementation in emergency settings.Chapter 8.Surveillance,monitoring and evaluation(M&E)explains how to assess malaria risk and track outbreaks in emergencies.It emphasizes the establishment of early warning systems,surveillance systems,and outbreak detection mechanisms.It provides M&E frameworks and indicators to ensure accountability and continuous learning in emergency malaria response.Development of the manual and methodologyThe development of this manual followed a rigorous,collaborative process designed to ensure technical soundness,contextual relevance and practical applicability.A dedicated Working Group on Malaria Control in Humanitarian Emergencies was established,comprising experts selected for their technical expertise and field experience.All members signed a Declaration of Interest(DOI),and no conflicts of interest were reported or identified.Sub-teams were formed to draft individual chapters,aligning responsibilities with specific areas of expertise.The content was shaped through an extensive consultation process,beginning with two in-person meetings to review current practices in emergency response and align guidance with the WHO guidelines on malaria.These discussions were further refined through a series of virtual meetings aimed at achieving consensus on each chapter.The manuals guidance is grounded primarily in existing WHO malaria guidelines to maintain alignment with global standards,while carefully adapting interventions to emergency contexts to prioritize feasibility,relevance,and operational practicality.In deliberating on interventions,the Working Group assessed factors such as feasibility in resource-constrained or crisis-affected settings including supply chain limitations and staffing shortages along with resource requirements like cost,infrastructure,and the availability of tools such as rapid diagnostic tests and insecticide-treated nets.Equity was also a key consideration,with attention to ensuring access for vulnerable groups such as displaced populations,children and pregnant women.Epidemiological relevance was evaluated by considering local malaria transmission patterns and overlapping health burdens like malnutrition and concurrent infections.Where WHO guidelines did not provide emergency-specific evidence,the Working Group incorporated lessons from field experiences and well-documented case studies,and identified interventions with potential benefit for operational research or pilot implementation in crisis settings.The inclusion of case studies for each chapter was determined based on relevance,operational feasibility,scalability and impact,with expert consensus ensuring context-appropriate guidance for emergencies.External resources were carefully selected based on their evidence base,relevance to emergency contexts,and impartiality,with particular attention to avoiding materials containing conflicts of interest from contributors or funders,and excluding implementers promotional claims.Malaria control in emergencies:field manual4Chapter 1.Malaria epidemiology and control in emergencies1.1 OverviewHumanitarian emergencies significantly disrupt health systems and exacerbate vulnerabilities within affected communities,posing substantial challenges for malaria control.The displacement of populations into settlements for refugees or internally displaced persons(IDPs)often results in environmental modifications that create optimal breeding sites for malaria vectors,thereby increasing transmission risk.Malaria is frequently a leading cause of morbidity and mortality during emergencies,particularly in regions with moderate to high transmission.The health impact of emergencies is further compounded by the heightened risk and severity of comorbidities,such as malnutrition,which weaken immune responses and increase susceptibility to malaria.The coexistence of concurrent public health crises,including disease outbreaks,further complicates malaria prevention,diagnosis and case management.Effective malaria control in emergency contexts requires a multi-sectoral,coordinated response.Humanitarian assistance must be context-specific,ensuring that interventions are tailored to the emergencys nature and phase.This involves harmonizing activities among partners,fostering active participation of local actors,and ensuring accountability among all stakeholders.Interventions must be delivered with efficiency and precision to mitigate the health impact of malaria in these complex settings.1.2 Introduction to humanitarian emergencies1.2.1 Definition and scopeThe world is affected by humanitarian emergencies on an unprecedented scale with devastating health,economic,political and societal consequences,both immediately and in the long term.Humanitarian emergencies have major impacts on the health and well-being of communities,resilience of health systems and stability of national economies,slowing progress towards the United Nations Sustainable Development Goals.Control of malaria and other communicable diseases during humanitarian emergencies can be particularly challenging.5A humanitarian emergency is a situation in which the functioning of a community or society is severely disrupted,causing suffering and losses that exceed the affected populations ability to cope using its own resources.They may be caused by instability or conflict or by natural disasters,such as earthquakes,floods or drought.Humanitarian emergencies often involve population displacement,food insecurity and malnutrition,and health systems disruptions that cause excess mortality and morbidity in affected populations.A complex emergency is a humanitarian emergency that occurs in a country,region or society where there is a total or considerable breakdown of authority resulting from conflict,requiring an international response that goes beyond the mandate or capacity of any single agency and that the Inter-Agency Standing Committee(IASC)assesses requires intensive and extensive political advocacy and coordination(3).Despite the existence of standards,the quality of humanitarian assistance is often variable,even within the same context.The Grand Bargain,agreed between donors and humanitarian organizations in 2016,outlined priorities for improving humanitarian assistance,including through localization,participation of communities and the provision of quality funding and sustainable aid(4).The 2023 revision of the Grand Bargain is aimed at better effectiveness and efficiency,strengthened partnerships and accountability to all constituencies.Malaria control interventions in emergencies should be implemented in the spirit of the Grand Bargain,ensuring that partners harmonize their interventions,the participation of local actors,accountability to each other and communities,and the efficient and effective delivery of interventions.1.2.2 Types and phasesSudden-onset emergencies involve a suddenly deteriorating situation,such as the impact of an earthquake or flood.Slow-onset emergencies involve a gradually deteriorating situation;for example,food insecurity developing into a nutrition crisis.Protracted emergencies are drawn-out emergencies with consistently high levels of humanitarian need and often lower levels of aid,as the root causes of the emergency remain unresolved.Humanitarian emergencies involving conflict frequently become protracted.The nature and duration of the humanitarian emergency affects malaria control.This field manual addresses malaria control in different types of emergency settings.Increasingly,humanitarian emergencies involve forcibly displaced persons settling in host communities and urban areas.Providing humanitarian assistance in these out-of-camp settings is more complicated than in settlements or camps.It is important to expand assistance to host communities to address their needs alongside those of refugees or IDPs.Understanding which phase an emergency is in can help guide how humanitarian aid should be provided.These phases generally consist of acute,protracted and recovery phases,summarized in Table 1.Humanitarian emergencies can evolve rapidly and unpredictably,including by moving back and forth between acute and protracted phases,with or without recovery.Malaria control in emergencies:field manual6Table 1.Phases of humanitarian emergenciesPhaseSudden onset crisisSlow-onset crisisProtracted crisisPhase 1(acute)First 2472 hoursFirst 12 weeksOngoing for more than 6 monthsPhase 2(acute)First 410 daysFirst monthNot applicablePhase 3(protracted)46 weeks for natural disasterUp to 3 months for conflict23 monthsIndefinite(continued low-level response)Phase 4(recovery)Continued response and progressive recoveryNot applicableSources:adapted from WHO(5)and Howard et al.(6)1.3 Malaria epidemiology1.3.1 Malaria,where it occurs and who is affectedMalaria is a life-threatening disease caused by protozoan parasites of the genus Plasmodium,transmitted between humans by Anopheles mosquitoes.Even though malaria is largely preventable and treatable,nearly half of the worlds population is still at risk of malaria infection(see Fig.1).Malaria transmission occurs when humans come into“contact”with Anopheles mosquitoes that are infected with Plasmodium parasites.This typically happens when an infected mosquito bites a human,injecting sporozoites into the bloodstream.The risk of infection depends on the frequency and intensity of these interactions,as well as the level of Plasmodium transmission in the area.The risk of infection depends on the frequency and intensity of human-mosquito interactions,the density of infected mosquitoes,and the level of Plasmodium transmission in the area,including local transmission dynamics,environmental conditions,and the presence of vector control measures.An estimated 263 million malaria cases occurred in 2023(an increase of 14 million cases from 2021),resulting in an estimated 597 000 malaria deaths,making it the third most deadly infectious disease in low-income countries after tuberculosis and HIV(7).By the end of 2023,83 endemic countries reported indigenous malaria cases.The WHO African Region accounted for about 94%of cases and 95%of deaths globally.Eleven countries,namely Burkina Faso,Cameroon,Democratic Republic of the Congo,Ghana,Mali,Mozambique,Niger,Nigeria,Uganda,United Republic of Tanzania and Sudan,account for more than 70%of cases and deaths.Nine of these countries are experiencing protracted conflict.Some have other factors favouring the high transmission of malaria;the countries in the Sahel,the Horn of Africa,southern and eastern Africa,and some parts of Asia are increasingly affected by extreme weather events such as long droughts and severe flooding.For example,the main countries contributing to the increase in cases between 2022 and 2023 were Ethiopia( 4.5 million),Madagascar( 2.7 million),Pakistan( 1.6 million),Nigeria( 1.4 million)and the Democratic Republic of the Congo( 600 000)all of which experienced displacement(8).7Fig.1.Estimated(a)malaria cases per 1000 population at risk,and(b)malaria deaths per 100 000 population at risk,2023 a Estimated malaria cases per 1000 population at riskb Estimated malaria deaths per 100 000 population at riskSource:World malaria report 2024(7)Estimated malaria incidence,2023(per 1000 population at risk)15051100101200201300301400Countries certifed malaria-freeNot applicableCountries where malaria is naturally absent or has been eliminated through control measures00200040001000kmEstimated malaria mortality,2023(per 100 000 population at risk)12021404160618081140Countries certified malaria-freeNot applicableCountries where malaria is naturally absent or has been eliminated through control measures00200040001000kmMalaria control in emergencies:field manual8In Asia,the Western Pacific,South and Central America,the risk of malaria is generally much lower(except for Papua New Guinea),and high transmission is much more focal than in Africa,mainly due to less-efficient vector species.Local transmission of malaria is often restricted to small hotspots populated by high-risk groups such as forest dwellers,while large areas and populations around and in between them have very low or non-existent transmission.In the Amazon basin,very high malaria transmission is reported by gold and gem miners around illegal mines.Implementing effective control in these settings requires in-depth knowledge of the local vector species and their breeding and biting habits.The most common and dangerous malaria parasite is Plasmodium falciparum,which can cause fatality.The second most common parasite,P.vivax,is mainly found in cooler areas at higher altitudes with lower malaria transmission.P.vivax malaria is usually not fatal but can involve serious illness.Fig.2 shows the areas of the world at risk of P.falciparum and P.vivax malaria.The other human malaria parasite species are rare(accounting for less than 5%of cases).In emergency settings,all malaria parasite species can be treated with the same medication as P.falciparum.Zoonotic P.knowlesi occurs in focalized areas in some South-East Asian countries,including Malaysia and Indonesia,and is of less relevance to emergencies(9).Fig.2.Areas at risk of P.falciparum and P.vivax malaria,2024Source:Malaria Atlas Project,2025(10).1.3.2 Signs and symptoms of malariaMalaria may be uncomplicated or complicated(severe).Uncomplicated malaria:the clinical features of malaria are variable but typically include weakness,fever,chills,headache,muscular aches and abdominal pain.This may be followed by shortness of breath,vomiting,diarrhoea and drowsiness.Vomiting can make oral treatment difficult.The initial Primary malaria risk 2024 Pf only Pv only Pf and Pv No malaria No data Not applicable9symptoms are nonspecific and may easily be mistaken for other febrile illnesses,contributing to delays in seeking appropriate treatment for malaria.All cases with fever or a history of fever should be assessed as part of fever management with parasitological diagnosis.Complicated(severe)malaria:when uncomplicated malaria due to P.falciparum is not treated within 24 hours with the appropriate medication,it may progress into a severe form.Symptoms of severe malaria include one or more of the following:impaired consciousness,coma(cerebral malaria),prostration,multiple convulsions.metabolic acidosis,severe anaemia,hypoglycaemia,severe malarial anaemia,renal impairment,jaundice or pulmonary oedema(11).The illness may be further complicated by haemolytic anaemia,in which red blood cells are destroyed faster than they can be replaced(12),leading to renal failure or pulmonary oedema and respiratory failure.Patients with severe malaria often become comatose.Severe malaria requires intensive care.Malaria can have a very short time interval between the onset of symptoms and death.If complicated malaria is not treated within 24 hours,it may be fatal,particularly in P.falciparum cases.Early recognition of signs and symptoms and timely diagnosis and treatment within 24 hours are therefore critical before cases progress to severe malaria that requires referral and case management using commodities(e.g.oxygen,blood)that may not be readily available in emergency contexts.1.3.3 Altitude,temperature,rainfall,seasonality and climate changeThe malaria parasite can only be naturally transmitted between humans by mandatory passage through an Anopheles mosquito(called the“vector”).Inside the mosquito,the parasite undergoes certain developmental stages that require a median daily temperature of 20 C for P.falciparum and 18 C for P.vivax.This temperature requirement explains why malaria transmission is lower or absent at altitudes above 2000 m,even in the tropics or in temperate zones(13).There are,however,recent reports of malaria cases in areas above 2000 m in the Ethiopian and Kenyan highlands,where climate change is contributing to warming at higher altitudes where malaria was traditionally absent(14).Malaria transmission is lower or absent during the cooler winter months of the year,even at lower altitudes,especially as winter is often the dry season.As an example in China during its elimination efforts,the effects of temperature on malaria parasite development are illustrated in Fig.3(a)shows the variation of the parasite development rate of P.falciparum and P.vivax(expressed as 1 over the number of days to parasite development)with temperature.Fig.3(b)shows the temperature-dependent R0(the number of cases generated by one infected individual)for P.falciparum and P.vivax.Fig.3(c)shows the seasonality of temperature-dependent relative R0(reproductive potential)of P.falciparum and P.vivax in three regions,that differ in altitude.Fig.3(d)shows the average seasonal incidence of malaria for the same three regions.Malaria control in emergencies:field manual10Fig.3.Time and temperature required for transmission of malaria between vectorsP vivaxP falciparum0.150.10Parasite development rate0.05010152025303540Temperature(oC)a32R010101520253035Temperature(oC)bNorthern plain regions1.00.60.8Relative R0(temperature)0.40.20123456789 10 11 12Month534Incidence(1 per 10 000)210123456789 10 11 12MonthcSouthern hilly regionsdCentral highland regionsababcdSource:Wang et al.(15).Rainfall increases malaria vector density by creating areas of stagnant water that become larval habitat.Rainfall affects the timing of malaria transmission in several ways.The high malaria season begins about 4 weeks after the start of the rains.During this 4-week period,mosquitoes hatch and grow old enough to become infectious.Transmission is usually highest at the end of the rainy season and during the month immediately following it.This is because heavy rains or flooding during the height of the rainy season may wash out larval habitat.The duration of the high transmission season is roughly as long as the rainy season.The Horn of Africa,Great Lakes subregions and the Indian subcontinent have two rainy seasons(long and short rains).In these areas,most transmission takes place between the second and third quarter of the year.The Sahel countries typically have seasonal malaria transmission coinciding mainly with the rainy season(ranging from 36 months).The malaria parasite lifecycle is summarized in Fig.4.11Fig.4.Malaria parasite lifecycleContact between vector and human limited from dusk to dawnInfecting vectorSexual cycle 12 days at median daily temperatures 20 C for P.falciparum18 C for P.vivaxInfector vectorTransmission by gametocytes only possible more than 15 days after infectionMalaria parasite lifecycleInfected human1.3.4 Immunity against malariaRepeated Plasmodium falciparum infections in endemic areas lead to the development of partial immunity,which provides protection against severe forms of the disease.Individuals with partial immunity typically remain asymptomatic but may still carry and transmit the parasite,acting as contacts persons who,through close association with an infected individual or a contaminated environment,have the opportunity to acquire the infection.Partial immunity is therefore most evident in adolescents and adults living in high-transmission settings.In contrast,young children in these areas are at the greatest risk of severe malaria or death,as they are immunologically naive.They only begin to develop partial immunity after experiencing and surviving multiple malaria episodes,frequently with the assistance of treatment.Pregnant women,particularly primigravidae,are at higher risk of severe malaria because of lower immune responses.Malaria can cause maternal and newborn anaemia,miscarriage,stillbirths and low birth weight.Acquired partial immunity to malaria can be lowered by malnutrition,measles or other concomitant infectious diseases.Acquired partial immunity can also be lost after 2 years if an individual is not reinfected.In highland and arid areas that are either too cold or unfavourable for parasite development,populations of all ages remain non-immune and thus susceptible to severe malaria illness and death if displaced to higher endemic areas.Malaria vaccines(RTS,S/AS01 and R21/Matrix-M)confer partial immunity,reducing malaria cases,including severe malaria,by more than 50%during the year after vaccination.Vaccines may not play a critical role during the acute phase of an emergency but could be useful later if the district is eligible for vaccination(stratified as moderate or high burden),and young children are at particular risk.Many humanitarian emergencies become protracted,justifying the integration of the malaria vaccines with other primary health care services(2).Malaria control in emergencies:field manual121.3.5 Transmission potential of different vector speciesThe likelihood of being infected with malaria largely depends on how biologically fit the locally dominant vector is for transmitting malaria.Anopheles gambiae and closely related species are the most effective and dangerous malaria vectors but are only endemic in sub-Saharan Africa.This explains the transmission intensity in sub-Saharan Africa and why approximately 96%of the global malaria burden is reported there.An.stephensi,an important malaria vector in South Asia,has spread through the Horn of Africa since 2016,and is now established in several areas in sub-Saharan Africa(16).An.stephensi has the following special characteristics that should inform the malaria control response.It can breed in artificial water containers,cisterns,etc.and,as such,has been responsible for dry season outbreaks and urban malaria(17).It is highly zoophilic,often associated with domestic animals,and feeds early and outside,complicating vector control efforts.It has a high level of insecticide resistance.1.4 Malaria in emergenciesGlobal displacement reached 113.3 million in 2023,including 75.9 million IDPs and 37.3 million refugees,driven by conflict,disasters and crises.Of these,nearly 80 million were displaced in 43 malaria-endemic countries(up from 39 in 2019),with 51.3 million(64%)being conflict-driven IDPs across 43 countries and 5.8 million(7%)being IDPs driven by natural disaster across 51 countries.Combined,conflict and disasters displaced 57.1 million in these regions,leaving 22.7 million displaced globally from other causes.This surge heightens malaria risks due to disrupted healthcare,overcrowding and resource shortages,demanding urgent health-focused interventions in unstable,disaster-prone areas.Figs.5,6 and 7 highlight rising conflict-linked displacement in endemic zones since 2019,and the countries disproportionately affected by emergencies.Fig.5.Proportion of IDPs and refugees in malaria endemic countries(79.8 million)Natural disaster 7%Refugees 29%Conflict 64%Source:World malaria report 2024(7)13Fig.6.Comparison of displaced persons in endemic and non-endemic countries,20192023Endemic-IDPs due to conflict and violenceNumber of displaced people(million)80604020020192020202120222023Non-endemic-IDPs due to conflict and violenceEndemic-IDPs due to natural disasterNon-endemic-IDPs due to natural disasterEndemic-RefugeesNon-endemic-RefugeesSource:World malaria report 2024(7)Fig.7.Proportions of a)IDPs due to humanitarian emergencies in malaria endemic countries and b)refugees from malaria endemic countries,2023Other countries 3%Burkina Faso4%Myanmar5%Nigeria6%Ethiopia7%Somalia7%Yemen8%Colombia9ghanistan10mocratic Republic of the Congo12%Sudan16%Other countries 10%Nigeria2ntral African Republic3%Somalia4mocratic Republic of the Congo4%Myanmar6%Sudan7%South Sudan10%Venezuela(Bolivarian Republic of)27ghanistan28IDMC:Internal Displacement Monitoring Centre;IDPs:internally displaced persons;UNHCR:United Nations High Commissioner for Refugees.a:Humanitarian emergency IDPs are displaced due to disaster and conflict and violence.Refugees reflected here are those recorded under UNHCR mandate and other people in need of protection based on country of origin.b:The top 10 countries with the most IDPs due to humanitarian emergencies and refugees are shown.Source:World malaria report 2024(7)Malaria control in emergencies:field manual14The response to malaria or a malaria epidemic differs depending on whether the setting is non-emergency or emergency,and also varies across different types of emergencies.There are three major malaria emergency scenarios:malaria in humanitarian emergencies in moderate to high transmission settings(non-epidemic)malaria epidemics in humanitarian emergencies malaria in the context of other public health emergencies.In emergency situations in moderate to high transmission areas,the incidence of malaria may not substantially increase,but there may be an elevated risk of severe illness and death due to the disruption to established health care and vector control interventions.A malaria epidemic exists when the incidence of cases in an area rises rapidly and markedly above its usual(or seasonal)level or when there is an outbreak in an area where malaria was not previously present.Often the threshold 75th percentile above cases in the last three to five years is taken as cut-off line for identifying malaria epidemic.The WHO malaria surveillance,monitoring and evaluation reference manual describes various simple calculations and thresholds for early detection of malaria epidemics(18).Early detection enables appropriate control or response measures to be accelerated.Even though in recent years,the geographical scope of humanitarian emergencies has greatly expanded within the Middle East and eastern Europe,most protracted humanitarian emergencies are in sub-Saharan Africa,which accounts for more than 90%of malaria cases and deaths,for the reasons outlined in Section 1.2.1.4.1 Malaria epidemics in non-emergency situationsMalaria epidemic-prone areas are inhabited by populations without previously acquired immunity.For example,a population may lack immunity because they live in an area at a high altitude that is too cold for proper parasite development within the mosquito.These areas are not necessarily malaria-free anymore,as malaria has been reported in areas up to 2000 m and at higher altitudes in rare cases(19).Populations living in areas that are naturally too arid for mosquito breeding will not develop immunity,while populations in areas that have experienced droughts for two or more consecutive years may have lost their acquired immunity.For a malaria epidemic to occur,conditions must be suddenly favourable for transmission.This can arise from heavy flooding after long droughts(e.g.Pakistan in 2022),increasing temperatures at high altitudes due to extreme climatic events(20),an influx of people carrying malaria parasites from moderate to high transmission areas into an area of low or unstable transmission,or a non-immune population moving from a low transmission area to a moderate to high transmission area.A combination of these is also possible.Malaria epidemic preparedness and response in non-emergency situations should be implemented by national malaria control programmes(NMCPs)in line with the WHO malaria,monitoring and evaluation reference surveillance manual(18).151.4.2 Malaria in humanitarian emergencies in moderate to high transmission settings(non-epidemic)Malaria is often the biggest contributor to illness and death during humanitarian emergencies,especially in sub-Saharan Africa where humanitarian emergencies often occur and persist within high transmission areas(21).Large population displacements typically result in reduced or lost vector control interventions and disruption of essential health services,including access to early malaria diagnosis and treatment.In emergencies,malaria control should be prioritized regardless of whether the disease is classified as epidemic or non-epidemic to prevent avoidable illness and death,especially among children,pregnant women and non-immune populations who are moving from highlands to endemic areas,as was the case for IDPs in northern Ethiopia in 2021(22).In responding to emergencies,it is imperative to anticipate and mitigate risks.In emergencies in high transmission settings,the number of malaria cases may not increase significantly beyond seasonal variations but could lead to high numbers of malaria deaths and all-cause child mortality among non-immune populations.1.4.3 Malaria epidemics in humanitarian emergenciesMalaria outbreaks can easily occur in IDP or refugee settlements in moderate to high transmission areas,where modification of the environment(e.g.construction,stagnant pools of water,poor waste management,crowding)creates favourable conditions for mosquito breeding and malaria transmission.The use of malaria epidemic thresholds(18)helps understand case numbers in the context of usual and seasonal levels and can help identify and respond to an epidemic early.However,typical malaria outbreaks cases often escalate rapidly and are evident in the number of outpatients at one or several health facilities or by the increase of hospitalizations in severe cases.1.4.3.1 ComorbiditiesMalaria and comorbidities in emergencies result in high all-cause child mortality.Malnutrition,particularly acute malnutrition,compromises natural immunity,increasing susceptibility to infectious diseases,especially in children.Malaria and other infectious diseases can aggravate or precipitate malnutrition through decreased appetite and food intake,vomiting,diarrhoea,malabsorption and nutrient loss in the face of increased metabolic needs.Malnutrition is,in the latter sense,not simply a consequence of inadequate food supply but a result of recurrent infections that may cause anaemia and other conditions,leading to increases in all-cause child mortality.This vicious cycle of malnutrition and disease has been well documented for many years and highlights the importance of a comprehensive and multisectoral approach to managing acute malnutrition.Children under 5 years and pregnant women are at particularly high risk of developing severe malaria due to their naturally low immunity,which malnutrition,measles and other common infections may further decrease.Children with severe acute malnutrition(SAM)have compromised immunity and,hence,are vulnerable to severe malaria and other infections and death.Malaria control in emergencies:field manual16Malaria can lead to a high mortality rate in children with SAM.Another consequence of their compromised immunity can be that they may not always mount a fever response and so in malaria endemic areas,SAM children with generalized signs of being unwell(including hypothermia)should be routinely tested for malaria.Accessing appropriate preventive and curative paediatric care as well as measures such as sleeping under ITNs is important to limit the severity of prevent malaria in children;however there is evidence that these measures can also contribute towards preventing acute malnutrition,thus interrupting the vicious cycle of infection and malnutrition(23).In humanitarian emergencies,comorbidities of malaria and SAM are a common phenomenon in children,leading to high child mortality.This is often exacerbated by increased rates of diarrhoeal illness and acute respiratory infections such as pneumonia,also prevalent in many humanitarian emergencies.Unfortunately,in some emergencies,these multifactored diagnoses are identified too late or not appropriately managed,including due to lack of ITNs,the disruption of essential health services,inadequate knowledge and skills of health workers(including community health workers CHWs),or lack of medical commodities and supplies.A key driver of acute malnutrition is the seasonality of livelihood systems given that they directly impact food security,care and health behaviours and outcomes(24).Therefore,understanding the trends of child wasting in food insecure and fragile contexts and the seasonality of the relevant livelihoods in addition to the seasonality of malaria is key when designing integrated programmes.Children aged under 5 years who present with suspected malaria should also be screened to identify and properly manage SAM in line with the WHO growth standards(25).Children aged under 5 years with acute malnutrition who present with uncomplicated P.falciparum malaria may be at higher risk of delayed parasite clearance,artemisinin-based combination therapy(ACT)treatment failure and reinfections.This is because acute malnutrition impacts medicine absorption and metabolism(26).Children with SAM and any signs of severe malaria should be referred for inpatient management for both malaria treatment and appropriate nutritional treatment.Children with SAM and malaria without any signs of severity can be treated as an outpatient but with close follow-up and a low threshold to refer for inpatient care if there is no improvement in their clinical condition(27).Children with moderate acute malnutrition should be screened and treated for malaria as per children without acute malnutrition(with the same admission criteria used for inpatient care)but as they have higher total energy requirements than children without acute malnutrition,an assessment must be made if they can likely meet those needs through their home diet or if they will need nutritional supplementation;especially to fully recover from episodes of illness such as malaria and to prevent further deterioration of their nutritional status to SAM.It is important to include school-aged children,who are also a high-risk group for malnutrition and malaria in multisectoral interventions(28).17Fig.8 shows the causes of morbidity and mortality during the humanitarian emergency in Borno State,Nigeria.Fig.9 presents the odds ratio for mortality from all causes by weight for height for children aged under 5 years.Fig.8.Cross sectional survey on all causes of morbidity and mortality(1016 October 2016),humanitarian emergency in Borno State,Nigeria Measles0.5%Morbidity(641 435 cases in total)Mortality(901 cases in total)Manutrition7.8%Diarrhoea8.7ute respiratory 13.3%Other20.8%Malaria49.0%Manutrition1.9%Maternal5.2ute respiratory infection6.1%Diarrhoea8.7%Other28.1%Malaria50.1%infectionSource:adapted from UNHCR,2016(29)Fig.9.Odds of all-cause mortality by weight for height for children under 5 yearsMore than 12 to 13 to 2 3Odds ratioWeight-for-heightThe reference category is children with a weight-for-height 90%of malaria cases and deaths occur in sub-Saharan Africa,where many humanitarian emergencies also take place.In moderate and low transmission settings,epidemics can arise when transmission is reintroduced.Use national malaria maps,epidemiological reports,and WHO malaria transmission classifications.If data are unavailable,conduct a rapid malaria prevalence survey in displaced populations.3.Identify high-risk populationsWhich groups are at the highest risk of severe malaria and mortality?High transmission areas:Children under 5 years,pregnant women,displaced individuals from low-transmission zones.Low transmission or epidemic-prone areas:All age groups due to lack of immunity.Other high-risk groups:Malnourished children,people with coexisting diseases(e.g.,HIV/AIDS,tuberculosis),marginalized groups,and individuals with reduced immunity.Those living in overcrowded settlements or shelters with high mosquito exposure.Identify whether displaced populations have been previously exposed to malaria.Prioritize high-risk groups for preventive interventions(e.g.,SMC,ITNs,chemoprevention).Consider interactions with other outbreaks(e.g.,measles,cholera,dengue)that may increase malaria vulnerability.4.Determine seasonal transmission patternsIs malaria transmission seasonal or perennial?When do the rains come,and how long does the peak transmission season last?Seasonal malaria transmission results in peak case surges during and after the rainy season,requiring timely interventions such as SMC.Perennial transmission leads to cases throughout the year,though seasonal peaks still occur.Use local meteorological data,historical surveillance and rainfall patterns,and satellite precipitation models to anticipate malaria trends.Stockpile essential malaria commodities(e.g.,RDTs,ACTs,ITNs)in advance of seasonal peaks.21StepKey assessment questionsEpidemiologic features and key considerationsRemarks and action points5.Assess population displacement risksAre displaced populations moving between high and low transmission areas?Are they transiting through high-risk areas?Movement from low to high transmission zones:High risk of severe malaria and mortality due to lack of acquired immunity.Movement from high to low transmission zones:Can introduce malaria into previously low-risk populations,leading to localized outbreaks.Risk factors for malaria transmission:Mass displacement into areas with limited vector control.Lack of malaria awareness among non-immune populations.Deploy MDA of SMC in high-risk groups in transit or upon arrival.Monitor imported malaria cases in newly affected low-burden areas and respond.6.Evaluate shelter and vector control accessDo affected populations have adequate shelter and malaria prevention measures(e.g.,ITNs,IRS-treated shelters)?Inadequate housing increases exposure to mosquito bites,particularly at night.In camps or temporary settlements,lack of IRS,ITNs,and protective clothing elevates risk.If ITNs were distributed over two years ago,efficacy may be reduced due to wear and tear.Conduct emergency ITN distribution in high-risk areas(if shelter is available).Assess feasibility of IRS campaigns in temporary shelters.Promote household-level vector control(e.g.,repellents,screening of shelter openings).7.Assess potential for increased malaria vector breedingHave environmental changes(e.g.,flooding,hurricanes,deforestation)increased stagnant water and mosquito breeding?Floods,heavy rainfall,and disruptions to drainage systems create new breeding grounds for Anopheles mosquitoes.Post-flood settings require urgent LSM.Conduct entomological assessments to evaluate mosquito population density.Mobilize community-based LSM activities(e.g.,drainage clearing,larviciding).Consider targeted IRS in flood-prone areas.Malaria control in emergencies:field manual22StepKey assessment questionsEpidemiologic features and key considerationsRemarks and action points8.Assess impact on routine malaria servicesHave malaria diagnosis and treatment services been disrupted?Are health workers and CHWs still operational?Conflict,insecurity,and natural disasters often lead to health facility closures,supply chain breakdowns,and workforce attrition.In some emergency settings,CHWs can sustain malaria care through integrated community case management(iCCM).Deploy mobile malaria teams in areas with disrupted services.Ensure sufficient RDTs,ACTs,and parenteral artesunate are prepositioned.9.Evaluate surveillance capabilitiesCan malaria surveillance systems function during the emergency?What data gaps exist?Surveillance may be compromised due to disruptions in data collection,reporting structures,and access to health facilities.Missed or delayed reporting leads to underestimation of the true malaria burden.Displaced people do not represent the local population.Integrate malaria case tracking into emergency disease surveillance.Utilize digital and community-based reporting tools to compensate for facility-based data loss.10.Overall evaluation of the emergency responseHow were the speed of intervention,impact on cases and deaths,the adequacy of resources,and the integration of malaria control efforts within broader emergency health responses?Timeliness and impact of the response in reducing transmission and averting deaths Adaptability to evolving conditions of the emergency Coordination and integration with other health services Conduct periodic evaluations during and after the emergency.Document lessons learned to improve ongoing or future responses.Include feedback from affected communities in evaluations.When including malaria control in emergency response efforts,several factors should be considered to select the most appropriate interventions for reducing mortality.These include:immediate responses for individual patient survival addressing high-risk groups effectiveness of interventions in reducing mortality speed of intervention delivery operational feasibility of reaching high-risk groups logistics for scaling up preventive and life-saving interventions within emergency responses.Urgency in malaria emergencies is affected by transmission intensity,access to care and available supplies.The speed of intervention hinges on preparedness.23Initial focus should be on saving lives and protecting the vulnerable,then gradually reinstating comprehensive malaria control efforts.Decisions on actions should consider effectiveness,operational challenges and costs.It is necessary to address local hurdles,such as security,and explore partnerships with organizations that aid high-risk groups to ensure effective delivery of services.Specific interventions are described briefly below and key malaria response actions in emergency settings are summarized in Table 3.These interventions are described in more details in Chapters 3,4 and 5.Table 3.Summary of priority malaria response actions in emergenciesArea of interventionActionCase managementTesting(RDT and microscopy)Strengthen case management by providing RDTs and microscopy for accurate diagnosis.Treatment for P.falciparum malariaEnsure access to quality assured ACTs(QAACTs),including doses of rectal and injectable artesunate for severe malaria.Treatment for P.vivax malariaEnsure access to radical treatments for P.vivax,including primaquine where appropriate.ChemopreventionMass drug administration(MDA)Implement MDA for at-risk populations within a determined catchment area,ensuring proper dosing,coverage,and surveillance.Seasonal malaria chemoprevention(SMC)Implement SMC for eligible children during high transmission periods,ensuring proper dosing and coverage.Vector controlIndoor residual spraying IRSAssess feasibility of conducting IRS in the emergency setting,considering logistics,safety and access.Insecticide-treated net(ITN)Evaluate behavioural and sleeping space suitability for hanging ITNs,ensuring communities are aware of proper use and maintenance.Larval source management(LSM)Target mosquito breeding sites,especially in displaced populations and temporary settlements where traditional vector control measures like IRS and ITNs may be insufficient or impractical.1.5.1 Case managementIn emergencies,establishing quick access to malaria diagnosis and treatment is vital.In areas in which services are interrupted,re-establishing or expanding case management is a priority when health services are inaccessible.Utilizing mobile clinics and CHWs helps bridge the gap.Mapping functional health facilities and budgeting for diagnostic tests and drugs are essential.Prioritizing the supply of malaria RDTs and ACTs,including for the management of severe cases,is critical.Adequate stock for treatments and tests should be based on transmission levels and the size of the population affected.Treatment alone is not enough to reduce overall morbidity;vector control and chemoprevention are also necessary.Malaria control in emergencies:field manual241.5.2 Chemoprevention1.5.2.1 Mass drug administrationMass drug administration(MDA)is a crucial response to drastically reduce transmission and avert mortalities during malaria outbreaks and in the early phase of emergencies,serving as an effective measure even when vector control methods are in place.MDA for malaria involves the large-scale distribution of antimalarial medications to populations in endemic areas,regardless of whether individuals show symptoms of malaria,along with low-dose primaquine to halt transmission.Targeted MDA for children aged under 5 years,followed by monthly chemoprevention,is vital in high-transmission areas to prevent excess mortality.The costeffectiveness of the MDA should be viewed in relation to the significant role it plays in saving lives during emergencies.MDA is highly effective if antimalarial medicines have been pre-positioned and implemented early enough at high coverage(80%).1.5.2.2 Seasonal malaria chemopreventionSeasonal malaria chemoprevention(SMC)involves administering periodic antimalarial treatment to children during the high malaria season to clear existing infections and prevent new ones,especially in regions with highly seasonal transmission.SMC could be a crucial intervention during acute crises if antimalarial medicines are pre-positioned,offering rapid intervention by swiftly reducing malaria cases in emergency situations with high transmission rates.1.5.2.3 Perennial malaria chemopreventionPerennial malaria chemoprevention(PMC),formerly known as IPTi,involves giving full antimalarial courses at set intervals to children in moderate to high malaria transmission areas,regardless of their current malaria status.PMC seeks to protect children aged 12 to 24 months from severe malaria by maintaining preventive drug levels in their bloodstream to clear and prevent infections during high-risk periods.1.5.2.4 Intermittent preventive treatment for malaria in pregnanciesIntermittent preventive treatment for malaria in pregnancies(IPTp)involves giving antimalarial medication at specific intervals during pregnancy to reduce risks to both mother and baby.The updated recommendation advocates for using sulfadoxine-pyrimethamine(SP)in the second and third trimester of the first and second pregnancies.Gravidity,malaria transmission intensity and SP resistance are considered for optimal effectiveness.1.5.2.5 Post-discharge malaria chemopreventionPost-discharge malaria chemoprevention(PDMC)is the administration of a full antimalarial treatment course at regular intervals to children admitted with severe anaemia.The purpose of PDMC is to prevent new malaria infections in children admitted with severe anaemia during the period after hospital discharge when they are at high risk of readmission or death.25For protracted emergencies where sustained preventive measures are required,PMC,IPTp and PDMC are more suitable in moderate to high transmission settings,ensuring continuous chemoprevention for the vulnerable target population.Case study 1.Responding to malaria upsurges during the Ebola outbreak in Uganda,September 2022 to January 2023In September 2022,Ugandas Ministry of Health declared an Ebola outbreak in Mubende District caused by the Sudan Virus Disease(SVD).The outbreak spread to nine districts,with 142 confirmed cases and 55 deaths.Simultaneously,a malaria epidemic affected 70 districts,including the Ebola epicentre,and over half of the children with Ebola had malaria coinfections,many with negative outcomes.Overlapping symptoms of the two diseases often led to misdiagnoses,compounding the pressure on the health care system.Fear of Ebola and lockdown measures further reduced access to essential health care services,including malaria prevention and treatment.In response,Ugandas health authorities implemented key mitigation measures that are vital for countries experiencing dual outbreaks of malaria and Ebola or a similar infectious disease.To ensure continuity of malaria prevention,they distributed ITNs to vulnerable groups,including people with suspected and confirmed Ebola,health workers and responders;conducted IRS in health facilities and Ebola treatment centres;and conducted LSM in communities.Chemoprophylaxis was provided for at-risk populations such as patients with sickle cell disease,non-immune travellers and health workers.MDA was carried out in areas within 5 km of confirmed Ebola cases,with the first dose observed and subsequent doses delivered door-to-door by CHWs.To ensure that Ebola case management appropriately considered malaria risk,health workers and CHWs were trained to screen for both diseases and offer presumptive malaria treatment.Severe malaria cases were treated three doses of intravenous(IV)artesunate,switching to IV quinine,if necessary,with follow-up treatment upon discharge.Health workers and CHWs were expected to observe strict infection prevention and control measures as transmission often happened while providing routine care in health facilities and the community,outside of Ebola treatment units.Strengthening coordination between malaria and Ebola response teams ensured alignment in messaging and technical support for the response to both outbreaks.Monitoring and timely sharing of malaria surveillance reports optimized malaria interventions within the Ebola response framework.Social behaviour change/risk communication and community engagement played a vital role in promoting the importance of early diagnosis and the use of ITNs,stressing that malaria,though less feared,kills more people than Ebola.Logistics teams ensured the continued availability of essential malaria commodities and supported frontline providers in forecasting and ordering malaria supplies to avoid stockouts and programmatic disruption.This comprehensive strategy helped effectively mitigate the impact of both diseases amid the dual malaria and Ebola crises.Source:Uganda Ministry of Health,Public Health Emergency Operations Centre and NMCP(unpublished data).Malaria control in emergencies:field manual261.5.3 Vector controlIn emergencies,swift treatment saves lives in malaria cases but does not reduce transmission.Therefore,vector control plays a critical role,especially in crowded settlements where high transmission levels can lead to severe disease burdens.Implementing WHO-recommended strategies such as IRS or distributing ITNs is vital to combat malaria.IRS swiftly reduces local transmission by spraying insecticides on shelters interior surfaces.Effectiveness is influenced by walling materials and insecticide choice.ITN distributions aim for universal coverage to protect individuals,even before shelters are fully established,but timely supply and correct usage is crucial for their effectiveness.LSM may be necessary in crowded environments to tackle new breeding sites and can be effectively implemented early in the response.Other vector control interventions pending WHO recommendation that may be used in large-scale implementation projects in emergencies include passive emanators(spatial repellents),attractive targeted sugar baits(ATSB),topical repellents,treated clothing,insecticide-treated textiles and treatment of domestic animals.Choosing the most feasible and effective vector control method promptly is crucial.When vector control interventions cannot be deployed immediately,MDA could be considered as a temporary solution until a suitable vector control method can be implemented.For detailed guidance on WHO-recommended MDA and vector control strategies,refer to Chapters 4 and 5,respectively.Further readingThe following resources provide valuable further information or access to relevant tools related to this chapters content.The latest WHO Guidelines for malaria should always be consulted.They can be accessed via the website or mobile app.Background note for the IASC Principals,update on the“New Way of Working”.Geneva:Inter-Agency Standing Committee;2016(https:/interagencystandingcommittee.org/principals/news-public/background-note-iasc-principals-update-new-way-working).Bloland PB,Williams HA,National Research Council(US)Committee on Population,Program on Forced Migration and Health at the Mailman School of Public Health,Columbia University.Malaria control during mass population movements and natural disasters.Washington,D.C.:The National Academies Press;2002(https:/www.ncbi.nlm.nih.gov/books/NBK221150/).Chandramohan D,Zongo I,Sagara I,Cairns M,Yerbanga RS,Diarra M,Nikima F,Greenwood B et al.Seasonal malaria vaccination with or without seasonal malaria chemoprevention.N Engl J Med 2021;385:1005-10(https:/www.nejm.org/doi/full/10.1056/NEJMoa2026330).27 Datoo MS,Dicko A,Tinto H,Bosco Oudraogo JB,Hamaluba,M,Olotu A,et al.Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children:a multicentre,double-blind,randomised,phase 3 trial.The Lancet,Volume 403,Issue 10426,533-544(https:/doi.org/10.1016/S0140-6736(23)02511-4).RTS,S Clinical Trials Partnership.Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa:final results of a phase 3,individually randomised,controlled trial
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Compendium on respectful maternal and newborn careCompendium on respectful maternal and newborn care III World Health Organization 2025 Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence(CCBY-NC-SA3.0IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy 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holder.The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recom-mended by WHO in preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.Design and Illustrations by Ina Fiebig/Sonder Collective.Compendium on respectful maternal and newborn careISBN 978-92-4-011093-9(electronic version)ISBN 978-92-4-011094-6(print version)ContentsIntroducing the compendium 1 Why focus on respectful maternal and newborn care 2Core principles for ending mistreatment and achieving respectful care 5 About this compendium 6A roadmap for this compendium 10References 13Understanding the history and terminology of respectful maternal and newborn care 15 Key milestones,concepts and terminology 16 Manifestations and drivers 24Spotlight:Perinatal mental health and respectful maternal and newborn care 30Recap and whats next 31References 32Deepening understanding of the drivers and areas of intervention to end mistreatment and achieve respectful maternal and newborn care 35 Drivers as contributors of mistreatment and enablers of respectful care 36 Areas of interventions to end mistreatment and achieve respectful maternal and newborn care 40Examples from the field:Multicomponent interventions to strengthen respectful maternal and newborn care 58Spotlight:Newborn right to identity:Birth registration 65Recap and whats next 66References 66Foreword VI Acknowledgements VII123IV VCompendium on respectful maternal and newborn care ContentsDriving change:implementing respectful care in practice 73 Planning for respectful care in the programme context 74Stakeholder engagement 76 Spotlight:Policy dialogue 83Implementation planning 84Conducting implementation cycles 92Undertaking advocacy in support of respectful maternal and newborn care 96Final reflections for implementation in practice 97Spotlight:Stillbirth,early neonatal death and bereavement 99 Recap and whats next 100References 101Measuring mistreatment and respectful maternal and newborn care 103 Purpose measuring respectful maternal and newborn care 104 Data collection approaches 105Validated measurement tools for assessing mistreatment and respectful maternal and newborn care 106Monitoring types of indicators 110Evaluation 114Ethical considerations for measurement 118Recap and whats next 120References 12Charting a path to respectful maternal and newborn care 123 Advancing respectful care 126Summary 127References 127Annexes 129 Annex 1:Methodology to develop the compendium 130Annex 2:Contributors to the compendium 132Annex 3:Respectful care recommendations from WHO guidelines 134Annex 4:Tools and approaches to plan and measure respectful maternal and newborn care 136Annex 5:Reflections from the field understanding and implementing respectful maternal and newborn care 153References 1694*56VICompendium on respectful maternal and newborn care VIIForeword&acknowledgementsForeword This compendium on respectful maternal and newborn care has come at a critical juncture marking 10 years since the 2014 WHO statement on the prevention and elimination of disrespect and abuse during childbirth.It reaffirms a global commitment to ensuring that maternal and new-born care is not only clinically sound but also grounded in dignity,compassion,and respect.Quality,respectful,person-centred care is not a luxury or an optional add-on it is a fundamental human right and a cornerstone of effective health systems.The urgency of this issue is clear.Mistreatment of women continues to undermine health outcomes,violate rights,and erode trust in health services.Without respectful care,we cannot achieve global health targets,including those outlined in the Sustainable Development Goals.Respect must be embedded in every interaction,across the full continuum of maternity care from antenatal to childbirth and postnatal services.Over the past decade,a growing body of evidence has highlighted the widespread impact of mistreat-ment and the necessity of centring respectful care in all maternal and newborn health strategies.This compendium outlines the core concepts and evolving global understanding of respectful care,offering a shared language and vision for action.The World Health Organization(WHO),United Nations Childrens Fund(UNICEF),United Nations Population Fund(UNFPA),Jhpiego and USAID MOMENTUM Country and Global Leadership project,gratefully acknowledges the contributions that many individuals and organizations have made to the development of this compendium,as listed in the Annex.Work on this compendium was initiated and coordinated by Hedieh Mehrtash and zge Tunalp from the United Nations Development Programme(UNDP)/UNFPA/UNICEF/WHO/World Bank Special Programme of Research,Development and Research Training in Human Reproduction(HRP),and Anayda Portela from the Department of Maternal,Newborn,Child and Adolescent Health and Ageing(MCA).A technical working group developed the draft content of the different sections including:Patience Afulani(University of California at San Francisco(UCSF),Kwame Adu-Bonsaffoh(University of Ghana Medical School/Korle-Bu Teaching Hospital),Meghan Bohren(University of Melbourne),Tamar Kabakian-Khasholian (American University of Beirut),Kathleen Hill(Jhpiego and USAID MOMENTUM Country and Global Leadership project US collaboration concerned preceded 20 January 2025),It also explores the many forms of mistreatment and the systemic drivers that perpetuate them ranging from structural inequalities to gaps in policy,training,and accountability.Addressing these root causes is essential to creating enabling environments where respectful,person-centred care can thrive.The compendium highlights key intervention areas and provides practical,adaptable approaches for designing and implementing respectful care strategies across different levels of the health system.It emphasizes the importance of engaging all stakeholders from health workers to women in communities and using routine data and documentation to drive accountability,learning,and sustainable change.This resource is designed to support programme managers,policy-makers,and practitioners in translating principles into action.By offering practical guidance based on research and programme experiences and implementation tools,it empowers health systems to uphold dignity,improve outcomes,and ensure that every woman and newborn receives the care they deserve.Let this be a renewed call to action to:prioritize respect,protect rights,and ensure that all maternal and newborn health care is safe,supported,and empowering.Dr Jeremy FarrarAssistant Director-GeneralDivision of Health Promotion,Disease Prevention&ControlRachael Hinton(RH edit Consulting,Switzerland),Shanon Mcnab(Jhpiego and USAID MOMENTUM Country and Global Leadership project US collaboration concerned preceded 20 January 2025),Katie Moore(Anthrologica),Helen Smith(Anthrologica),Charlotte Warren(Population Council),and Melanie Wendland(Sonder Collective).The methods used to develop the compendium are detailed in Annex 1.A list of participants in all content review meetings,along with the external reviewers,is provided in Annex 2.This work was funded by the United States Agency for International Development(USAID)and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research,Development and Research Training in Human Reproduction(HRP),a cosponsored programme executed by WHO and through a grant received by WHO/MCA from Merck Sharp&Dohme(MSD)for Mothers.The views of the funding bodies have not influenced the content of this compendium.Acknowledgements 1 1Introducing the compendium2 3Box 1.A note on inclusive languageCompendium on respectful maternal and newborn care Introducing the compendiumPregnancy,childbirth and the transition after birth are significant life events,with the health and well-being of women,gender-diverse people and their newborns closely intertwined.Respectful care is linked to other key concepts,such as high-quality,person-centred and rights-based care across the life course,as well as nurturing care for newborns and young children(Fig.1).The World Health Organization(WHO)has devel-oped a quality-of-care framework for maternal and newborn health that addresses both the provision and experience of care(1,2).Respectful maternal and newborn care is central to this framework.WHO standards for improving the quality of maternal and newborn care in health facilities(1)and the care of small and sick new-borns(3)also emphasize respectful care.However,in many settings,quality care standards are not being met.Gains in respectful care can be undermined by health system pressures,as seen during the COVID-19 pandemic or in conflict settings(4).Many women,gender-diverse people and their newborns continue to experience mis-treatment,including physical and verbal abuse,stigma and discrimination,non-consented care,lack of dignity and confidentiality,detention,abandonment,delays and neglect(510).Without addressing the quality of services,including experience of care for the 140 million women giving birth annually,global and national targets for reducing maternal newborn and child mortality will not be met.Why focus on respectful maternal and newborn careRIGHTS-BASED CARERESPECTFUL MATERNAL AND NEWBORN CAREEnsuring health care that is available,accessible,acceptable,and of high quality;and incorporates human rights-based principles of participation,non-discrimination and equality.Refers to care organized for and provided to all women and newborns in a manner that maintains their dignity,privacy and confidentiality,ensures freedom from harm and mistreatment,and enables informed choice and continuous support during labour and childbirth.NURTURING CARERefers to a stable environment created by parents and other care-givers that ensures childrens good health and nutrition,protects them from threats,and gives newborns and young chil-dren(up to age 3)opportu-nities for early learning and developmentally support-ive care,through interac-tions that are emotionally responsive.All people have access to health services that are provided in a way that responds to their preferences,are coordi-nated around their needs and are safe,effective,timely,efficient and of an acceptable quality.PERSON-CENTRED CAREPregnancy&childbirthOlder PersonPostnatal care&newborn careAdulthood(25 years)Infant (01 years)Youth(2024 years)Child(15 years)Adolescents(1019 years)Older child(69 years)QUALITY OF CARE Provision of care Experience of care Essential physical resources available Competent and motivated human resourcesPERSON-CENTRED CARERespectful maternal and newborn care means person-centred care organized for,and provided to and with,all women,gender-diverse people,newborns,parents and families throughout the antenatal,childbirth and postnatal periods(see Box 1.A note on inclusive language).It prioritizes dignity,protects against harm and mistreatment,and ensures freedom to make informed choices.The terms“women and gender-diverse people”inclusively refer to individuals with the reproductive capacity for pregnancy and birth,including cisgender women,and people who are transgender,non-binary,gender-fluid,two-spirited,intersex,and gender non-conforming.The term“women”is used alone when reflecting existing data sources,which predominantly derive from maternal health studies conducted with cisgen-der women.The limitations of these data sources are acknowledged.Lesbian,bisexual,queer,transgender,non-binary,gender-fluid,two-spirited,intersex or gender non-conforming people face unique challenges navi-gating pregnancy,childbirth and the transition to parenthood,as well as in their interactions with health services.Ending mistreatment and achieving respectful maternal and newborn care requires addressing these needs and providing equitable,high-quality care for all.Many individuals receiving maternity care are adolescents,who often face a higher risk of mistreatment due to their age.While their specific needs are sometimes highlighted,the terminology“women and gender-diverse people”is used throughout the compendium and is not intended to exclude adolescents experiencing pregnancy,childbirth or the transition to parenthood.Fig.1:Intersections between respectful maternal and newborn care and relevant concepts across the life course.Source:Adapted from USAID(11)4 Compendium on respectful maternal and newborn care 5Introducing the compendiumCore principles for ending mistreatment and achieving respectful careeThis compendium emphasizes the goal of“ending mistreatment and achieving respectful care and for all women,gender-diverse people,newborns,parents,and families”.This goal is underpinned by six core principles:Be aspirationalUphold rights-based careAchieve equity and non-discriminationFocus on person-centred care Ensure safe and confidential careAddress complexityRespectful care is the standard.This aspiration is turned into action by setting national goals,strengthening systems for routine data collection and review,and implementing interven-tions for ending mistreatment and achieving respectful care.Delivery of care is grounded in human rights,paving the way for a future where respectful high-quality care is universally accessible.Respectful,high-quality care is the standard for everyone regardless of social,ethnic,economic or gender identities,backgrounds or experiences.Care is tailored to the needs and preferences of women and gender-diverse people and their newborns,while inclusively supporting parents and families.Care prioritizes physical and emotional safety,guarantees confidentiality and prevents harm in all interactions.Maternal and newborn health care is multi-faceted,as individuals may experience both mistreatment and respectful care.Ending mistreatment alone does not ensure respectful care.Achieving respectful care means actively identifying and tackling instances of mistreatment,whether intentionally or by omission.123456Midwife Zetoon Abdullah speaks with a new mother at the maternity ward at the Juba Teaching Hospital,Juba,South Sudan.Photo:UNICEF/Naftalin6 7Introducing the compendiumTarget audienceThis compendium is primarily for programme managers responsible for maternal,newborn and child health initiatives and services within ministries of health at national,subnational,facility and community levels.Since health systems vary,these roles may also be referred to as coordinators,directors or other titles.”Programme manager”is used inclusively to encompass these roles,as well as senior-level managers overseeing financing,training and medical education for programming.The compendium applies to all income settings and to both government and non-government organizations.It is also useful for policy-makers and stakeholders working to improve respectful care,including professional associations,international and community organizations and researchers.The compendium serves as a practical guide for understanding,designing,implementing and monitoring interventions to end mistreatment and achieve respectful care based on current evidence.This work can be carried out in collaboration with teams focused on maternal,newborn and child health as well as quality-of-care initiatives.While programme managers may initiate or lead these efforts,activities for ending mistreatment andachieving respectful care can also be integrated into facility-level quality improvement processes led by health workers or service users.About this compendiumEmbroidery on womens birthing experiences,South Africa.Copyright:Intuthuku Embroidery Project8 9Introducing the compendiumScope of this compendiumThe compendium supports efforts to end mistreatment and achieve respectful maternal and newborn care,marking a decade since the WHOs 2014 statement on the prevention of disrespect and abuse during facility-based childbirth.Despite substantial progress in understanding and measuring respectful care,large-scale implementation remains limited.Emerging research has highlighted small-scale interventions,but there is still much to learn about the most effective approaches.Another major challenge is the lack of documentation of many respectful care initiatives,limiting knowledge-sharing and the scaling of interventions.Additionally,ending mistreatment and achieving respectful care is complex,and requires multilevel coordination within health systems.Addressing these challenges demands engagement among various stakeholders including women,gender-diverse people,families,communities,civil society groups,policy-makers,health workers and researchers to identify barriers,tailor interventions and measure impact.The compendium underscores the importance of data-driven decision-making,offering validated tools and key indicators to track progress,refine strategies and sustain impact.It also recognizes that health systems vary in the progress they have made to end mistreatment and achieve respectful care:some countries having already established programmes,while others are only just beginning.It also offers essential context,evidence and guidance to support implementation in diverse settings.It outlines key concepts,terminology and the evolution of global thinking on respectful care,providing a foundation for designing and implementing interventions.Much of the current literature on mistreatment and respectful care focuses on childbirth and the immediate postnatal period.However,the compendium emphasizes that the core principles extend across the entire maternal and newborn care continuum including antenatal,childbirth and postnatal care and apply to all interactions women,gender-diverse people and newborns have with sexual and reproductive health services.Objectives of this compendiumThe purpose of the compendium is to consolidate key evidence,tools and resources to support the practical implementation of respectful maternal and newborn care across different contexts.It provides programme managers with essential background to build a foundational understanding of mistreat-ment and respectful care.As such,it serves as a comprehensive resource that integrates theory with practice.While not an implementation guide,the compendium supports programme managers to incorporate respectful maternal and newborn care into existing quality-of-care initiatives,ensuring it becomes a key component of maternal and newborn health efforts.Young mother breastfeeding in a park in Moldova.Photo:WHO/Sergey PetkogloIn the mother and child corner in the Tabanovce refugee and migrant centre,five-day-old Syrian baby Iliyas is getting dressed after a bath.Photo:UNICEF/Tomislav Georgiev10 11Compendium on respectful maternal and newborn care Introducing the compendiumA roadmap for this compendiumThe figure below gives an overview on the terms used in the compendium and explains how the elements are interconnected with each other in relation to respectful maternal and newborn care.Drivers of mistreatment and respectful careRead more in section 2Policy requirementsGender norms and gender equalityInclusion and non-discriminationWork environment and resources Training and education gapsPersonal attitudes and behavioursMotivation and well-beingPOLICY-RELATEDSOCIOCULTURALORGANIZATIONALINDIVIDUALAreas of interventionsRead more in section 3Enact policies,laws and standards Improve leadership and governance Promote a labour companion and family involvement in newborn care Tackle stigma and discriminationImplement quality improvement and supportive supervisionSupport health-worker well-being Engage community members through health education and mobilization strategiesImprove the facility and work environment Strengthen interpersonal communicationManifestations of respectful care and mistreatmentRead more in section 2Health systems conditionsDetention in facilitiesLack of bereavement careSeparation of newborns from their mothersNeglect and abandonmentStigma and discriminationVerbal abusePhysical abuseEffective communicationEmotional supportBodily autonomyFamily involvementPrivacy and confidentialityInformed consentPain reliefENABLE OR SUPPORTREDUCE OR ELIMINATEImplementing respectful careRead more in section 4IMPLENTATION GUIDANCEStakeholder engagementStrategic PlanningImplementation planningConducting implementation cyclesMeasurement strategies and toolsRead more in section 5MEASUREMENT GUIDANCERoutine data collection tools Indicators Research and evaluation Vision and outlookRead more in section 1 and 6RESPECTFUL MATERNAL AND NEWBORN CAREFig.2:Roadmap for this compendium12 Compendium on respectful maternal and newborn care 13References Section 1Standards for improving the quality of maternal andnewborn care in health facilities.Geneva:World Health Organization;2016(https:/iris.who.int/handle/10665/249155).Tunalp,Were WM,MacLennan C,Oladapo OT,Glmezoglu AM,Bahl R et al.Quality of care for pregnant women and newbornsthe WHO vision.BJOG.2015;122(8):1045-1049(https:/doi.org/10.1111/1471-0528.13451).WHO recommendations for care of the preterm or low birth weight infant.Geneva:World Health Organization;2022(https:/www.who.int/publica-tions/i/item/9789240058262).Koli D,Semaan A,Day L-T,Delvaux T,Delamou A,Benova L.Maternal and newborn healthcare providers work-related experiences during the COVID-19 pandemic,and their phys-ical,psychological,and economic impacts:Findings from a global online survey.PLoS Glob Public Health.2022 Aug 5;2(8):e0000602.(https:/pmc.ncbi.nlm.nih.gov/articles/PMC10021724/).Bohren MA,Mehrtash H,Fawole B,Maung TM,Balde MD,Maya E et al.How women are treated during facil-ity-based childbirth in four countries:a cross-sectional study with labour observations and community-based surveys.Lancet.2019;394(10210):1750-1763(https:/ D,Hill K.Exploring evidence for disrespect and abuse in facil-ity-based childbirth:Report of a landscape analysis.Washington,DC:USAID;2010(https:/www.hsph.harvard.edu/wp-content/uploads/sites/2413/2014/05/Exploring-Evi-dence-RMC_Bowser_rep_2010.pdf).1 2 3 4 5 6 7 8 9 10 11 Sen G,Reddy B,Iyer A.Beyond meas-urement:the drivers of disrespect and abuse in obstetric care.Reproductive health matters.2018;26(53):6-18(https:/pmc.ncbi.nlm.nih.gov/arti-cles/PMC10021724/).Sacks E,Mehrtash H,Bohren M,Balde MD,Vogel JP,Adu-Bonsaffoh K et al.The first 2 hafter birth:prevalence and factors associated with neonatal care practices from amulticountry,facility-based,observational study.Lancet Glob Health.2021;9(1):e72-e80(https:/doi.org/10.1016/s2214-109x(20)30422-8).Ashish KC,Moinuddin M,Kinney M,Sacks E,Gurung R,Sunny AK et al.Mistreatment of newborns after childbirth in health facilities in Nepal:Results from a prospective cohort observational study.PLoS ONE.2021;16(2):e0246352(https:/doi.org/10.1371/journal.pone.0246352).Abuya T,Warren CE,Ndwiga C,Okondo C,Sacks E,Sripad P.Manifes-tations,responses,and consequenc-esof mistreatment of sick newborns and young infants and their parents in health facilities in Kenya.PLoSONE.2022;17(2):e0262637(https:/doi.org/10.1371/journal.pone.0262637).United States Agency for International Development.People-centered care framework and intersections with respectful maternal and newborn care,rights-based care and nurturing care graphic.Washington,DC:USAID;2022.Embroidery on womens birthing experiences,South Africa.Copy-right:Intuthuku Embroidery Project2Understanding the history and terminology of respectful maternal and newborn care 14 1516 Compendium on respectful maternal and newborn care 17Understanding the history and terminology of respectful maternal and newborn careFor decades,advocates,activists,researchers and policy-makers have promoted ending mistreatment and achieving respectful care for all women,gender-diverse people and their newborns.However,as global efforts to improve respectful maternal and newborn care have expanded,so has the under-standing and terminology used to describe it.Fig.3 summarizes key milestones of social movements,research and policy advances in the field.Key milestones,concepts and terminologyFig.3:Key milestones of social movements,research and policy advances for respectful maternal and newborn care1947 Universal Declaration of Human Rights2011 Implementation of the research project Heshima in Kenya and Staha in the United Republic of Tanzania to estimate prevalence of disrespect and abuse and test interventions to improve respectful maternal care Respectful Maternity Care Charter:The Universal Rights of Childbearing Women2022WHO recommen-dations on maternal and newborn care for a positive postnatal experience2009United Nations Human Rights Council Resolution on Preventable Maternal Mortality and Morbidity 2007 Report Failure to deliver:violations of womens human rights in Kenyan health facilities2010Landscape analysis“Exploring evidence for disrespect and abuse in facility-based childbirth1959Declaration of the Rights of the child 1989United Nations Convention on the Rights of the Child(UNCRC)1979Convention on the Elimination of All Forms of Discrimination against Women2015Ending Preventable Maternal Mortality(EPMM)2016WHO recommenda-tions on antenatal care for a positive pregnancy experience WHO Standards for improving quality of maternal and newborn care in health facilities2014WHO statement on the prevention and elimination of disrespect and abuse in facility-based childbirth Every Newborn Action Plan(ENAP)1993 Declaration of the Elimination of Violence Against Women 2017Network for Improving Quality of Care for Maternal,Newborn and Child Health 2018Respectful Maternity Care Charter:The Universal Rights of Childbearing Women and NewbornsCampaign on What Women Want:Demands for Quality Healthcare for Women and Girls WHO recommendations on intrapartum care for a positive pregnancy experienceNurturing Care Frame-work for Early Childhood Development 1990sHumanization of childbirth movement begins in Latin America and Caribbean region Several rulings by Human Rights Bodies in recent years that have noted obstetric violence(OV)as a form of gender-based violence(GBV)and have declared States responsible for the violation of womens and their childrens human rights in cases of OV.2020WHO Standards for improving the quality of care for small and sick newborns in health facilities2019UN Special Rapporteur report on a human-rights based approach to mistreatment and obstetric violence during childbirthCouncil of Europes Parliamentary Assembly Resolu-tion on Obstetrical and gynaecologi-cal violence18 Compendium on respectful maternal and newborn care 19Understanding the history and terminology of respectful maternal and newborn careBrief history of respectful maternal and newborn care The rise of medical technology and facility-based births in the mid-20th century contributed to the increased use of interventions such as episiotomy and fundal pressure.While these interventions can be life-saving in certain situations,their routine use without consent or consideration of the medical context,individual needs,choices and preferences,can undermine both health benefits and rights.In the 1960s and 1970s the“humanization of child-birth”movement emerged,emphasizing a more holistic,woman-centred approach that recognized the importance of emotional,psychological and social factors during childbirth.It opposed the routine use of interventions without medical justifi-cation,highlighting the dangers of over-medicaliza-tion,including the overuse of caesarean sections,unnecessary episiotomies and other interventions that could harm both women and newborns.The humanization of childbirth movement in Latin America was particularly strong.It championed culturally sensitive care that respected diverse traditions and beliefs associated with pregnancy,birth and care of the newborn,including family involvement,safe traditional practices,and spiritual and cultural rituals.The movement also challenged social inequalities and the power dynamics between health workers and women,particularly within the strongly hierarchical health system.The movement coincided with a broader feminist response in the United States of America and elsewhere against the medical appropriation of womens bodies.This push-back paved the way for various initiatives that challenged disrespect and abuse in medical care.In the early 2000s,the term“obstetric violence”emerged,referring to both the overuse of medical interventions during childbirth and the mistreatment of women,including experiences of physical,verbal,sexual and psychological abuse and dis-crimination and stigmatization.Obstetric violence also covered violations of womens autonomy,decision-making and informed consent(1).The term continues to be used globally to describe and raise awareness about these violations,particu-larly in some legal contexts in Latin America(2).Argentina,Venezuela and parts of Mexico have passed laws against obstetric violence as a form of gender-based violence,outlining measures to prevent,punish and eradicate it.In 2010,a landscape analysis of evidence of mistreatment in facility-based childbirth intro-duced the phrase“disrespect and abuse during childbirth”.The aim was to highlight the poor treatment some women face,often due to health system conditions and constraints(3),and to increase understanding of actions that constitute disrespectful and abusive care.This framing brought the issue to the forefront of efforts to improve skilled birth attendance,as called for in the Millennium Development Goals(20002015).A 2015 systematic review synthesized evidence from 65 studies from 34 countries and proposed a typology,or classification,of common behaviours and characteristics,of the“mistreatment of women during childbirth”in health facilities(4).By focusing on womens experiences,this terminol-ogy confirmed how mistreatment can occur within Mother Kadidia Sangar(37)holds her newborn daughter Nahawa Kone,10 days old,at the Referrence Health Center in Bougouni,Mali.Photo:UNICEF/Ilvy Njiokiktjien20 Compendium on respectful maternal and newborn care 21Understanding the history and terminology of respectful maternal and newborn carea broader context of gender inequality and violence,spanning individual interactions between women and health workers all the way through to the health system itself,where systemic failures occur.Compared to terms like obstetric violence or disrespect and abuse,mistreatment was found to be less inflammatory,making it a more useful starting point for discussions with health workers and policy-makers.Since 2011,the concept of“respectful maternity care”has promoted a positive approach to the global maternal and newborn health agenda and facilitated engagement with health workers who provide maternity and newborn care services.The 2011 White Ribbon Alliance Respectful Maternity Care Charter exemplified this by highlighting womens rights in maternity care(5).Human rights advocacy for respectful maternity care has also clarified the entitlements of women.Similarly,“person-centred maternity care(PCMC)”promotes positivity and inclusivity in maternity care that is respectful to the needs of all individuals who become mothers,aligning with broader trends in person-centred care.In 2019,two prominent human rights entities also undertook comprehensive examinations of mistreatment during childbirth:the United Nations(UN)Special Rapporteur on violence against women and girls,and the Council of Eu-ropes Parliamentary Assembly,through its resolu-tion on obstetrical and gynaecological violence.Both concluded that this mistreatment constitutes a violation of womens rights and called for laws to prevent and combat such abuses,with an emphasis on tackling structural inequalities within health systems(6,7).The concept of respectful newborn care has followed a different trajectory than respectful maternal care.Many aspects of respectful new-born care have long been embedded in global initiatives such as the Baby Friendly Hospitals Initiative(1991),which was revised in 2018,the Neonatal Integrative Developmental Care Models emphasis on family-centred care(8)and the Nurturing Care Framework(9).These initiatives do not specifically refer to mistreatment but highlight responsive high-quality health care from birth throughout childhood,with respect and dignity as core concepts.The right to high quality,respectful care also extends to newborns.The 2018 update of the White Ribbon Alliance Respectful Maternity Care Charter included specific statements related to the rights of the newborn,such as their right to identity and nationality from birth,and to be with their parents or guardians(10).The types of mistreatment experienced by women during pregnancy and childbirth also apply to newborns.Common forms of mistreat-ment of newborns include abandonment and neglect at birth,non-consented care,stigmatization and physical abuse,which can include slapping,rough handling,denial of medical care and physi-cally inappropriate practices,such as around feeding.Mistreatment can also involve lack of bereavement care,unnecessary separation from mothers and detention in health facilities(11-15).These practices all violate the universal rights of the newborn to respectful care(10).Furthermore,since newborns cannot communicate verbally,non-ver-bal and heightened physiological cues,such as behavioural responses and pain profiles,provide valuable insights into their experiences and should be closely observed(16).Table 1 presents key concepts and terminology used to describe and understand respectful maternal and newborn care across major global documents,highlighting both similarities and differences in their definitions and framing.Mistreatment of women during childbirth(18)WHO standards for improving the quality of maternal and newborn care(20)Obstetric violence(1)Defining disrespect and abuse of newborns(11)Respectful maternity care(19)Person-centred maternity care(PCMC)(17)MATERNALMATERNAL AND NEWBORNNEWBORNUniversal rights of child-bearing women and newborns(10)Communication and autonomyEffective communicationLiberty,autonomy,self-determina-tion and freedom from arbitrary detentionDignity and respectPhysical abusePhysical abusePhysical abuseNon-dignifiedcareDiscriminatorycareNon-confidential careAbandonment(neglected care)Being free from harm and mis-treatmentRespect and preservation of dignityFreedom of harm and ill-treatmentTreatment with dignity and respectRight to health care and to the highest attainable level of healthPreserving womens dignityEngaging with effective communicationProvision of efficient and effective careProviding equitable maternity careFreedom from discrimination and equitable careRight to an identity and nationalityfrom birthMaintaining privacy and confidentialityLack of privacyNon-consented carePrivacy and confidentialityVerbal abuseVerbal abuseStigma and/or discriminationStigma and/or discriminationPoor rapport between women and providersPoor rapport between provider and newborn/familyRight to be with their parents or guardiansBereavment posthumous careEmotional supportive careFailure to meet professional standards of careFailure to meet professional standards of careRespecting wom-ens choices that strengthens their capabilitiesEnsuring continuous access to family and community supportProvision of information and seeking informed consentInformation,informed con-sent,and respect for their choices and preferencesAvailability of competent and motivated human resourcesHealth systems conditions and constraintsHealth systems conditions and constraintsEssential physical resourcesCompetent motivated human resourcesRight to adequate nutrition and clean waterDetention at the health-care facilitySupportive careLegal accountabilityCorruptionTable 1:Different concepts,terminologies across key global documents for respectful maternal and newborn care.22 Compendium on respectful maternal and newborn care 23Understanding the history and terminology of respectful maternal and newborn careWHO position on respectful maternal and newborn care In 2014,WHO published a statement on the prevention and elimination of disrespect and abuse during facility-based childbirth,which has since been endorsed by over 100 professional associations and nongovernmental and international organizations(21).The statement highlighted the importance of respectful maternity care for all and articulated five actions.1 Increase support from governments and development partners for research and action on disrespect and abuse during childbirth.2 Initiate,support and sustain programmes designed to improve the quality of maternal health care with a strong focus on respectful care as an essential component of quality care.3 Emphasize the rights of women to dignified respectful health care throughout pregnancy and childbirth.4 Generate data related to respectful and disrespectful care practices,systems of accountability and meaningful professional support.5 Involve all stakeholders,including women,in efforts to improve quality of care and eliminate disrespectful and abusive practices.Building on this statement,in 2016 WHO proposed new standards to improve the quality of maternal and newborn care in health facilities,particularly around the time of childbirth.The standards were aligned with the eight domains of the WHO frame-work for the quality of maternal and newborn health care,including those related to the experi-ence of care(see Table 1)(20).Current WHO guidelines on antenatal,intrapartum and postnatal care highlight that,when delivered as a package,this will contribute to high-quality and evi-dence-based care in all settings and should ensure positive care experiences for women and gen-der-diverse people(22 24).Specifically,in 2018,WHO published recommendations on intrapartum care for a positive childbirth experience,which included three specific recommendations on respectful care(see Table 2)(23).WHO was a signatory to the 2011 Respectful Mater-nity Care Charter and its update in 2018,which included statements on the rights of newborns(5,10).In 2020,WHO published standards for the care of small and sick newborns,including Standard 5,which emphasized the respect,protection and fulfilment of the rights of newborns and preserva-tion of dignity(25).Further,the 2022 WHO recom-mendations for the care of preterm and low-birth-weight newborns called for family involvement in newborn care.This was to ensure that newborns are always accompanied by family members who are directly involved in their care and medical decision-making and to reduce parental anxiety and stress(26).A list of related WHO recommendations on respectful maternal and newborn care is available in Annex 3.WHO recommendations on intrapartum care for a positive childbirth experience,related to respectful care(23)WHO recommendations for care of the preterm or low-birth-weight infant(26)Respectful maternity careCompanion of choice during labour and childbirthEffective communicationFamily involvementRespectful maternity care which refers to care organized for and provided to all women in a manner that maintains their dignity,privacy and confidentiality,ensures freedom from harm and mistreatment,and enables informed choice and continuous support during labour and childbirth is recommendedEffective communication between maternity care health workers and women in labour,using simple and culturally acceptable methods,is recommendedA companion of choice is recommended for all women throughout labour and childbirthFamily involvement in the routine care of preterm or low-birth-weight newborn in health-care facilitiesTable 2:Key WHO recommendations related to respectful maternal and newborn care24 Compendium on respectful maternal and newborn care 25Respectful maternal and newborn care refers to specific positive instances of care(19)as reflected in the WHO framework for the quality maternal and newborn health care(20,25).Mistreatment refers to specific negative instances and actions experienced by women,gender-diverse people and newborns(2,11,18).Understanding the history and terminology of respectful maternal and newborn careThe first part of this section introduced key concepts and terminology related to mistreatment and respectful maternal and newborn care.Building on this foundation,the following part examines the manifestations of mistreatment and respectful care,along with their drivers,which can both contribute to mistreat-ment and promote respectful care.Defining manifestations of mistreatment and respectful careIn the compendium the term“manifestations”applies to both positive and negative instances of respectful maternal and newborn care across the antenatal,childbirth and postnatal periods(see Fig.4).Negative experiences refer to mistreatment,such as stigma and discrimination,while positive experiences reflect aspects of respectful,person-centred care,such as privacy and confidentiality.Conversely,the absence of these positive manifes-tations such as lack of privacy or inadequate pain relief signifies mistreatment.The care experiences of women,gender-diverse people and their newborns are also interconnected with those of their husbands/partners,parents and families,requiring a holistic understanding of both mistreatment and respect-ful care(16).Both types of manifestations highlight the challenges and critical areas for ending mistreatment and achieving respectful care and reinforce the need for health system conditions and environments that prioritize respectful care.Manifestations and driversManifestations in the broader health system The broader health system environment is a cross-cutting factor that influences both mistreatment and respectful maternal and newborn care.Health systems conditions:This encompasses resources,infrastructure and adequate number of human resources needed in health facilities to support safe and effective maternal and newborn care.It includes facilities with a clean and suitable physical environment,enough beds,access to water,sanitation,energy,medicines,supplies and appropriate equipment to manage routine care and complications.Inadequate health system conditions can present serious risks during childbirth.For example,births may occur in unsanitary settings,or health workers may not be able to consistently follow proper hand hygiene protocols as outlined in WHOs “Five Moments for Hand Hygiene”(27).Newborns may also be exposed to suboptimal conditions,such as environments with excessive noise and bright lighting.Additionally,there are instances of inadequate preparation for birth and resuscitation,such as the absence of essential equipment for immediate newborn care or the use of adult-sized bag valve masks(ambu bags)for the resuscitation of newborns.Recognizing the spectrum of manifestationsThe global community is using insights from international initiatives and existing literature to address the needs of mothers,newborns,parents and families in the context of respectful maternal and newborn care.However,while the terminology of respectful care promotes human rights and collaboration with health workers,critics argue it may obscure the root causes of mistreatment.Specifically,some contend that framing respectful care as a solution risks overlooking the manifesta-tions of mistreatment,including intentional harm such as discrimination or the withholding of pain relief(15).Mistreatment can be both intentional and unintentional,and it is essential to differentiate between the two.Acknowledging these concerns and considering the different concepts and terminologies in Table 1,this compendium frames the issue as“ending mistreatment and achieving respectful care”.This is because both mistreatment and respectful care can coexist(see Fig.4).Individuals can experience positive aspects,such as clear commu-nication about their care.They can also experience negative instances,such as a lack of emotional support,including the absence of a companion of choice during labour and childbirth(hereafter called a labour companion)or a baby being sepa-rated from its mother/parents.Achieving respectful care requires not only addressing mistreatment but also actively promoting dignity,autonomy and compassion throughout the care experience.26 Compendium on respectful maternal and newborn care 27Understanding the history and terminology of respectful maternal and newborn careFig.4:Spectrum of manifestations of mistreatment and respectful maternal and newborn careEnding mistreatmentAchieving respectful careManifestations of mistreatmentManifestations of respectful careHealth systems conditionsDetention in facilities:Prohibiting women and their newborns from leaving facilities after childbirth due to an inability or failure to pay facility or medical fees.Lack of bereavement care:Involving a lack of organized form of bereavement and posthumous care in the case of babys death,including lack of emotional support and counselling.Separation of newborns from their mothers:Involving the loss of opportunities for bonding and attachment.It disrupts the initiation of early breast-feeding and limits skin-to-skin care,which helps maintain a babys body temperature.Neglect and abandonment:Involving prolonged delays in providing care and instances where women are ignored or left without support during their care.Stigma and discrimination:Withholding or providing care inequitably based on factors such as age,ethnicity,gender,socioeconomic status,sexual orientation or marital status.Verbal abuse:Using harsh or derogatory language,judge-mental or accusatory comments,shouting or screaming,also involving threats.Physical abuse:Using force or harmful physical actions,such as slapping,hitting,punching and applying fundal pressure during childbirth,rough handling of newborns or slapping the baby on the back to stimulate breathing.Effective communication:Ensuring clear and empathetic dialogue between health workers and women by actively listening and responding to their questions and concerns to foster trust and comfort.Emotional support:Providing time and attention to ensure women feel supported and adequately cared for during physical examinations and procedures.It also includes allowing a labour companion during labour and childbirth.Bodily autonomy:Ensuring women have the decision-making authority over their bodies and those of their newborns.Family involvement:Allowing families to participate in the routine care of newborns,including preterm or low-birthweight newborns in health facilities.Privacy and confidentiality:Ensuring information is shared in a private and secure environment to respect confidentiality and maintain privacy.Informed consent:Ensuring the active participation of women in decisions regarding their care and that of their newborn by providing relevant information about tests,procedures and physical examinations.Pain relief:Offering,discussing and responding to requests for available options,such as medications and other methods,to help women manage pain and discomfort effectively.28 29Compendium on respectful maternal and newborn care Understanding the history and terminology of respectful maternal and newborn careDefining the drivers of mistreatment and respectful careHaving explored the manifestations of mistreat-ment and respectful care,it is important to examine the factors that drive them.The term“drivers”refers to underlying factors that influence both the occurrence of mistreat-ment and the provision of respectful care.These factors fall into four categories:policy-related,sociocultural,organizational and individual drivers(see Table 3).In the compendium,drivers are framed as both contributors to mistreatment and enablers of respectful care.For example,policies can promote respectful care when laws,guidelines and account-ability mechanisms are in place,such as those supporting a labour companion,family involvement in newborn care and nurturing care.In contrast,the absence of such measures increases the likelihood of mistreatment and non-consented care.Similarly,sociocultural drivers such as gender norms can have both positive and negative influences supporting womens bodily autonomy in some cases or reinforcing harmful beliefs that devalue women in others.Laws,guidelines and accountability mechanisms that are in place for respectful maternal and newborn care,and to protect women,gender-diverse people and newborns from mistreatment.Beliefs,practices,gender and social norms,that can impede or promote fair and equal treatment of women,gender-diverse people,newborns and families.Factors within the health system,such as the availability of resources,adequate human resources,work environment,super-vision,training and education,and infrastructure,supplies and equipment,which affect the quality of maternal and newborn care.The attitudes and behaviours of health workers towards women,gender-diverse people and newborns,as well as the power dynamics and professional hierarchies that influence health-worker motivation and well-being.POLICY-RELATEDPolicy requirementsInequality,social and gender normsInclusion and non-discriminationSOCIOCULTURALWork environment Resources Training and education gapsORGANIZATIONALPersonal attitudes and behavioursMotivation and well-beingINDIVIDUAL DRIVERSTable 3.Definitions of different types of drivers that can contribute to mistreatment or enable respectful care19-days-old baby Acha in the village of Kotare,in the South of Niger.Photo:UNICEF/Frank Dejongh 31Understanding the history and terminology of respectful maternal and newborn care30 Compendium on respectful maternal and newborn care Perinatal mental health and respectful maternal and newborn careNearly one billion people worldwide experience some form of mental illness,with approximately 80%living in low-and middle-income countries(2830).Women bear a heightened burden as they experience higher rates of mental disorders during the perinatal period(31,32).Perinatal mental disorders,such as prenatal and postpartum depression,anxiety,and somatic disorders,are among the leading complications of pregnancy and childbirth globally(33).In low-and middle-income countries nearly one in five women suffers from one or more CPMDs,which can have long-term effects on their mental and physical health,functioning and quality of life(31).Health system factors contribute to this burden.Obstetric trauma such as miscarriage,stillbirth,having a small or sick newborn,and emergency caesar-ean sections,are risk factors for CPMDs(31,3436).Women with limited access to reproductive services are also at greater risk for anxiety and depression(3739).Moreover,evidence shows that womens experiences of mistreatment during pregnancy and childbirth can lead to mental health issues such as post-traumatic stress disorder and postpartum depression.When health workers face burnout or mental health challenges,they also struggle to offer respectful and dignified care.Adolescents are particularly vulnerable to CPMDs,and if girls aged 10 to 19 become mothers,they face a 63%risk of experiencing mental health challenges(41).The literature also highlights the stigma and discrimination that adolescent mothers often face,which underscores the urgent need for focused attention on mistreatment of this population.To address these challenges,it is crucial to ensure that health workers have the appropriate resources and training to provide culturally sensitive,person-centred psychological care.A 2022 call to action(42)emphasized the need for a critical mass of health workers dedicated to addressing the CPMD burden within their local contexts.Additionally,supporting the mental health of health workers is vital,as their well-being directly influences the quality of care they can provide.When they receive support to deliver woman-centred care,it positively impacts womens mental health.For example,midwife-led continuity of care is linked to improved perinatal mental health,particularly in high-in-come settings(43).Given the growing recognition of the connection between respectful maternal and newborn care and perinatal mental health,further research is warranted.While promoting the mental well-being of health workers may contribute to both respectful care and improved perinatal mental health,interventions to address respectful maternal and newborn care across the health system could also have a positive impact on overall CPMDs.A focused research agenda should explore how to successfully implement,measure,eval-uate and sustain maternal and newborn health services that support both womens perinatal mental health and health worker mental health,while promoting respectful maternal and newborn care.The WHO is leading efforts to define maternal well-being and develop globally applicable indicators for measuring perinatal mental health within existing systems(44).SPOTLIGHT:This section explored the history and evolution of respectful maternal and newborn care,highlighting key concepts and terminology.It also introduced the manifestations and drivers of mistreatment and respectful care.The next section provides a deeper understanding of the specific drivers of mistreatment and how they interact to create an environment where mistreatment can occur.Recap and whats nextMother Delgermurun Tsolomon(32)with her baby Sugarmaa Batjargal(8 days),in the families ger in the Alag-Erdene area in Mongolia.Photo:UNICEF/Njiokiktjien32 Compendium on respectful maternal and newborn care 33Understanding the history and terminology of respectful maternal and newborn care22 23 24 25 26 27 28 29 30 WHO recommendations on ante-natal care for a positive pregnancy experience.Geneva:World Health 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facilities.Geneva:World Health Organization;2016(https:/iris.who.int/handle/10665/249155).The prevention and elimination of disrespect and abuse during facili-ty-based childbirth.WHO statement.Geneva:World Health Organization;2014(https:/www.who.int/publica-tions/i/item/WHO-RHR-14.23).3 Deepening understanding of the drivers and areas of intervention to end mistreatment and achieve respectful maternal and newborn care 3534 36 Compendium on respectful maternal and newborn care 37Deepening understanding of the drivers and areas of intervention to end mistreatmentDrivers as contributors of mistreatment and enablers of respectful careAs described in Section 2,drivers are underlying factors that influence the occurrence of mistreat-ment and the provision of respectful care.These drivers,which may be policy-related,sociocultural,organizational or individual,can interact in complex ways to either increase the likelihood of mistreat-ment or enable respectful care.Table 5 provides a summary of the types of drivers of mistreatment and respectful care,with examples of how the drivers can contribute to mistreatment.However,the same drivers can also enable respect-ful care when the right conditions are in place.For example,policies,laws and guidelines related to labour companions can promote respectful care,but the lack of these can contribute to mis-treatment.By identifying and addressing the types of drivers that lead to mistreatment,its possible to target the root causes that hinder respectful care as part of developing an implementation plan.With a clear understanding of these drivers,strategies can be implemented to enable respectful care and prevent mistreatment.Table 5.Summary of the types of drivers of mistreatment and respectful maternal and newborn careInequality,social and gender normsInclusion and non-discriminationType of driverDescriptionExamples from the literatureSOCIOCULTURAL bBeliefs and practices that value women,gender-diverse people,newborns,parents,and familiesWhether all women,gender-diverse people and newborns are treated fairly and equallySocial and/or financial reliance on others(e.g.elder women,husbands,neighbours,health workers)for childbirth decisions(14,15)Patriarchal attitudes and cultural practices affect womens ability to register the birth of their child(16)Respectful care policies and interventions need to consider the interconnectivity between the local community,the culture of the local institution,and the sociocultural context in which both operate(17)Cultural competence and respecting the cultures,values and beliefs of women was highlighted by women and health workers as important in creating a positive atmosphere in the labour ward(18)Disempowerment of women due to societal hierarchies(19)Structural gender inequality is perpetuated by traditional practices that give women lower status in the family,workplace,community and society(11)Normalization of mistreatment influences womens low expectations about maternity care(10,14,20)Health workers/midwives face same inequalities as women;low social status,disrespect,bullying,inequality and patriarchal structures(11,15,21,22)Stigmatized groups(e.g.adolescents,ethnic group,racial group,caste,disability,refugee status)and those living in poverty more likely to experience mistreatment and non-consented care(23-25)Higher levels of mistreatment among adolescents and marginal-ized groups(26)Segregation of women and babies based on race,ethnicity or medical condition(9)Policy requirementsDescriptionType of driverExamples from the literaturePOLICY-RELATED aPolicies and guidelines,on respectful maternal and newborn care,labour companion,family involve-ment in newborn care,and nurturing care Laws and guidelines to protect against mistreatment of women,gender-diverse people and newborns during pregnancy,childbirth and the postnatal periodMechanisms to hold health programmes accountable Women without a labour companion more likely to report mistreatment or physical abuse(1)and non-consented care(2)Women typically not allowed a labour companion to act as an advocate and provide emotional support(3)Families denied any physical access to their infants and receive only intermittent verbal updates from health workers(47)“Rules”around visiting times prevent working fathers from seeing their newborn(8)Failure to instate legal and policy frameworks to protect the rights and needs of women and newborns(9)Lack of knowledge about rights among women in labour and early postnatal women and their families(10)Lack of mechanisms for women to share dissatisfaction,provide feedback on quality of care or hold health-workers accountable(11)Lack of mechanisms for policy-mandated violations of womens reproductive autonomy(i.e.sterilization programmes,policies that allow denial of care)(12,13)38 Compendium on respectful maternal and newborn care 39Deepening understanding of the drivers and areas of intervention to end mistreatmentPersonal attitudes and behavioursMotivation and well-beingType of driverDescriptionExamples from the literatureINDIVIDUAL dTypes of attitude of health workers towards women,gender-diverse people and newbornsBalance of power and professional hierarchiesLevel of occupational health of health workersWomens physical appearance and personal hygiene may determine how a woman is treated during childbirth(15,24)Norms and stereotypes about womens decision-making competence,or judgement about fitness for motherhood can affect care provided during childbirth(9,10)Lack of pain relief provided by health workers is related to training,normalization,poor supervision and cultural norms(e.g.expectations that women should bear pain;incorrect assumptions about the level of pain experienced by newborns)(33)Adolescents can be judged harshly by health workers(26)Denial of care,refusal of pain relief,segregation,detention or separation of women from their newborns based on lack of economic means to pay and punishment of women for non-payment of fees(9,19)Abuse of the concept of medical necessity to justify mistreatment(e.g.non-consented care for women and newborns,withholding information,misleading women,unnecessary clinical interventions)(9,20,3436)Women and health-workers deem slapping acceptable to ensure a positive outcome for the baby(11)Physical force,pinching women giving birth or holding newborn upside down deemed acceptable (11,19,37)Stressful work conditions,including workload,emotional exhaustion,anger and frustration,and inability to manage difficult situations,are linked to poor treatment of women(15,21,28,38)Health workers report the effects of emotional exhaustion,depression and burnout on the delivery of maternity care (21,35,38)Womens perception of staff as verbally abusive,rude,bossy,unhelpful,critical,easily angered and lacking compassion(14)and parents perception of health workers being unhelpful with newborns(24)a Policy-related:Laws,guidelines and accountability mechanisms that are in place for respectful maternal and newborn care,and to protect women,gender-diverse people and newborns from mistreatment.b Sociocultural:Cultural beliefs and practices,gender and social norms,that can impede or promote fair and equal treatment of women,gender-diverse people,newborns and families.c Organizational:Factors within the health system such as the work environment,supervision,training and education,and infrastructure,supplies and equipment that affect the quality of maternal and newborn care.d Individual:The attitudes and behaviours of health workers towards women,gender-diverse people and newborns as well as the power dynamics and professional hierarchies that influence health-worker motivation and well-being.Work environmentResourcesTraining and educationType of driverDescriptionExamples from the literatureORGANIZATIONAL cLevel of support for health workersType of leadership,management and supervisionLevel of infrastructureAvailability of supplies and equipmentAvailability of pre-and in-service training on respectful maternal and newborn care principles and practiceLevel of emphasis on family involvement in newborn careStrength of interpersonal communication skillsDisrespected,unsupported health workers;low salaries,physical resource constraints,understaffing,disempowering working conditions and limited scope to alleviate stress and foster motivation(11,27,28)Health-worker burnout linked to mistreatment(21)Health-worker shortages lead to women being mismanaged(19)Overworked,underpaid health workers lacking professional autonomy/disempowered(19,28,29)Inadequate training,poor supervision;women link mistreatment to poor training and overwork(27,28)Mistreatment of women often stems from a lack of compassionate leadership which influences team culture(15)Lack of privacy,beds,curtains,space for labour companions;stressful work environment due to resource shortages(2,11,14,19,26,28,30)Lack of educational materials for women and parents;lack of essential medicines and equipment for labour and childbirth and newborn care;lack of informed consent forms.Training norms promote professional distance to secure good outcomes(29)and focus on biomedical elements over the rights of women and newborns(8,31)Dehumanization of women begins in pre-service education as a learned behaviour(15)Reflected in poor communication by staff to parents of newborns(8)and lack of organized bereavement care in the case of an infants death(24,32)Poor communication,lack of effective understanding and information not in language spoken by client,provided in an inappropriate manner or insufficient to make informed decisions(9,19)40 Compendium on respectful maternal and newborn care 41Deepening understanding of the drivers and areas of intervention to end mistreatmentAreas of interventions to end mistreatment and achieve respectful maternal and newborn care Research on a broad set of effective interventions to improve respectful care policy and practice is rapidly growing,however the evidence base remains limited and varies across interventions.At this stage,a set of promising interventions has been identified to address the drivers of mistreatment and strengthen those that promote respectful care.The compendium refers to areas of intervention aimed at ending mistreatment and promoting respectful care as promising interventions,where evidence from reproductive,maternal,newborn and child health studies is limited or based on small-scale research.While these interventions show positive outcomes,further evaluation is needed to confirm their effectiveness(see Annex 1 for details on the methodology used to identify interventions).Fig.5 summarizes areas of intervention across different levels of the health system national,subnational,facility and community drawing on recommendations from WHO and the UN,systematic reviews and other literature.These promising interventions are categorized into areas of intervention based on the domains from a published review(39).WHO or UN standards or recommendationsWHO or UN best practice statements,remarks or implementation considerationsPromising strategies/interventionsRelated standards,recommendations,statements,considerations and promising interventions:National(N)Subnational(S)Facility(F)Community(C)This level of the health system encompasses a range of policy,strategy,financing,education and other activities implemented by actors and institutions that operate at national level.This level of the health system encompasses a range of activities that may be implemented at subnational level.This level of the health system encompasses a range of activities that are implemented in health facilities where women and newborns receive antenatal,labour,childbirth and postnatal care.This level of the health system encompasses a range of activities that are implemented at community level.Health system level at which intervention is aimed at:Interventions aimed at the national and subnational levels aim to strengthen policies,laws and standards;enhance leadership and governance;support subnational and facility levels;and advocate with partners to raise awareness.At the facility level,interventions centre on quality improvement,health-worker well-being,and engaging with women and gender-diverse people in their care,including ensuring their input on service provision.Community-level interventions include health education,community mobilization and grass-roots advocacy.Each of the following subsections includes a box that highlights standards,recommendations,best practices and/or promising interventions,with visual keys to aid understanding(i.e.the colour-coded sections and the health system levels of N/S/F/C).Enact policies,laws and standards Improve leadership and governance Promote labour companionship and family involvement in newborn care Tackle stigma and discrimination Implement quality improvement measures Support the well-being of health workers Engage community members through health education and mobilization strategies Improve the facility and work environment Strengthen interpersonal communication147258369Fig.5.Areas of intervention to end mistreatment and achieve respectful maternal and newborn careExplanation of icons and terms used in the following overviews:43Compendium on respectful maternal and newborn care 42 Deepening understanding of the drivers and areas of intervention to end mistreatmentNational and subnational laws can provide the framework and legal basis to create a health system that upholds the rights and dignity of women,gender-diverse people and newborns.Recommendations from the UN and the Council of Europe can guide countries in addressing mistreatment during childbirth using a human rights framework(9).Implementing policies and standards for respectful care and involving civil society in policy dialogue enhances the environment for respect-ful newborn and maternal care(39,40).Recommendation:respectful maternal and newborn care care organized for and provided to all women in a manner that maintains their dignity,privacy and confidentiality,ensures freedom from harm and mistreatment,and enables informed choice and continuous support during labour and childbirth(Global;41)A policy of respectful maternity care is in accordance with a human rights-based approach(Global;42)Written,up-to-date standards and benchmarks that outline clear goals,operational plans and monitoring mechanisms for respectful maternity care (Global 41)Integrate standards for respectful maternal and newborn care at all levels,including parental and family involvement in all care,non-sepa-ration of mother and newborn and communication support for families(Global;43)1Policy requirementsInclusion and non-discriminationDrivers addressed:Enact policies,laws and standards Review and strengthen laws and policies to prohibit the mistreatment of women during pregnancy and childbirth;laws and policies should ensure autonomy in decision-making,free and informed consent,privacy and confidentiality(Global;44,45)Ensure that policies,programmes and budgets promote health workforce educational and career development opportunities,pre-service education and in-service training of all health workers on respectful maternal care,in accordance with WHO norms and guidelines(Global;44,45)Improve and standardize the content,curricula and development of competence in neonatal care in pre-service programmes for health workers,emphasizing neglected topics,including family-centred,respectful care (Global;43)Ethnic midwife Sung Thi Cua visited Mrs.Sung Thi Ghenh,mother of Hang A Cua at her house,Pu Nhi commune,Dien Bien Dong District.Photo:UNICEF/Ho Hoang Thien Trang44 Compendium on respectful maternal and newborn care 45Deepening understanding of the drivers and areas of intervention to end mistreatmentOrganizational factors influence the behaviour of health workers,thus improving organizational structures and processes can enhance respectful maternal and newborn care(28).This can include strategies such as addressing staff shortages,providing supportive supervision and peer support and transforming leadership,all of which can be implemented regardless of resource limitations(21).A combination of interventions targeting structural and normative organizational change may positively influence the ability and willingness of health workers to provide respectful maternal and newborn care(28).Leadership and governance requirements for respectful maternal,newborn and child health,including:easily accessible mechanisms for service users and providers to submit complaints to management;and establishment of accountability mechanisms for redress in the event of mistreatment or violations(Global;41)Citizen Voice and Action an advocacy approach to transform dialogue between communities and health workers and government by educating citizens on rights and responsibilities and involving them in auditing services to assess whether they meet existing standards set by government(Global;51)2Drivers addressed:Improve leadership and governanceContinuous policy dialogue in tech-nical meetings with government,civil society and professional knowledge networks to compel critical actors to reflect on disrespect and abuse as a key component of quality of mater-nity care(part of a multicomponent package,the Heshima project)(Kenya;46)Ensure meaningful participation by women and civil society in all levels of legal and policy decision-making,and in monitoring(Global;44,45)Strengthen the capacity of regulatory bodies and health professional associations,including national human rights institutions,to exercise oversight over public and private birthing facilities(Global;44,45)Leadership transformation via a cooperative inquiry group to identify issues related to organizational culture,and to plan,implement and reflect on organizational changes(South Africa;48)Ethical leadership training for nurse managers to improve organizational culture and trust among peers and with supervisors(Republic of Korea;49)Leadership development training for frontline maternity care staff addressing organizational culture,leadership skills and interpersonal communication(Ghana;50)Strengthen mechanisms for the systematic reporting,monitoring and evaluation of mistreatment of women during childbirth in public and private health-care facilities(Global;44,45)For example,incorporate survey items on mistreatment domains into ongoing efforts such as demographic and health surveys and more targeted surveys(Ghana,Guinea,Myanmar,Nigeria;30)Ensure accountability for mistreat-ment of and violence against women during childbirth,including by:creating,strengthening and funding accountability mechanisms to foster the accountability of multiple actors at various levels,both within health-care settings and within the justice system(Global;44,45)Health facility committees to monitor quality,identify poor health-worker performance and improve accountability of health services(Malawi;47)Work environment Policy requirementsOne week after birth Hiwot is taking care about her baby Elizabeth in Ethiopia.Photo:WHO/Petterik Wiggers46 Compendium on respectful maternal and newborn care 47Deepening understanding of the drivers and areas of intervention to end mistreatmentQuality improvement interventions include evidence-based practices,continuous monitoring,and supportive supervision and feedback.For example,teams can monitor mistreatment cases and address issues related to infrastructure and organizational culture(46,52).Quality improvement frameworks,such as Plan-Do-Study-Act(PDSA)cycles,can help facilities identify problems and refine practices to improve care(41).Adopting client service charters and working in partnership with women and communities can help define and monitor care quality(53,54).Implementation guidance for improving quality of maternal,newborn and child health across system levels(national,district,facility)with community engage-ment,using an adapted PDSA model for continuous quality improvement(Global;41)Supervision and monitoring require-ments for reproductive,maternal,newborn and child health,including:regular supportive supervision by labour ward/facility lead;staff meetings to review respectful maternity care practices;establishment of informed consent procedures(Global;41)Team-based quality improvement and Improvement Collaborative model to improve womens childbirth experience(India;57)Strengthen facility quality improvement teams for monitoring,addressing and resolving disrespect and abuse cases and addressing infrastructure,drugs and commodity supply concerns(Heshima project)(Kenya;46)Post-training quality improvement supportive supervision visits to promote routine quality improvement within a respectful maternity care intervention(Ethiopia;58)Institutionalized quality improvement processes,quality improvement teams and PDSA cycles to implement maternal and newborn health quality of care standards(Bangladesh,Ghana,United Republic of Tanzania;52)Patient safety walkrounds to allow frontline staff to improve identification of patient safety incidents and their resolution,improve teamwork and open communication between providers and managers(Iran(Islamic Republic of);59)Mentorship on-the-job role-mod-elling of provider behaviour change towards reproductive,maternal,newborn and child health by identified facility champions,as part of routine continuous professional development(part of a multicomponent package,the Heshima project)(Kenya;46)Supportive supervision training for supervisors(including reproductive and child health staff on district health management teams and obstetric care facility managers),covering human resource management,supervisory and support skills and action learning to improve understanding and applica-tion of supportive supervision practices(United Republic of Tanzania;56)Use community-based assessment to identify mistreatment domains and hold the health system accountable(Ghana,Guinea,Myanmar,Nigeria;30)Adapt a national client service charter and a maternity ward quality improvement process to activate components of the charter;implementation by facility,district and community stakeholders(part of a multicomponent package,the Staha project)(United Republic of Tanzania;53)Partnership defined quality a participatory methodology to improve quality of services with community involvement in defining,implementing and monitoring the quality improvement process(Global;55)3Drivers adressed:Implement quality improvement measuresWork environment Motivation and Well-beingTraining and education gapsPersonal attitudes and behavioursCommunity Health Worker and Mothers Support Group Facilitator Mbalu Turay(right)meets with parents Kankay Suma(left)and Amara Turay in Masiaka Community,Kambia District,Sierra Leone.Photo:UNICEF/Michael Duff48 Compendium on respectful maternal and newborn care 49Deepening understanding of the drivers and areas of intervention to end mistreatmentThe facility environment significantly affects the well-being,motivation and performance of health workers.In countries with acute resource shortages,issues such as understaffing,heavy workloads and inadequate physical environments all contribute to unacceptable behaviour among health workers,including mistreatment of women and newborns(28).To support respectful care,improvements are needed in facility infrastructure,including private waiting areas,adequate lighting and bathrooms with hand-washing facilities.Additionally,ensuring manageable workloads,reliable access to supplies and equipment and safe working conditions with water and electricity are essential(39).Another important aspect is creating a care environment with the necessary infrastructure and policy changes to make facilities more adolescent-friendly(26).Access to a trusted labour companion can improve womens health outcomes and childbirth experiences by promoting autonomy and enhancing the relationship between women and health workers(3,43).Factors that affect the involvement of a labour companion include the level of awareness,health-worker attitudes,facility regulations and the availability of space and privacy in facilities(64).Similarly,involving families in newborn care improves outcomes,especially for preterm or low-birth-weight babies(65).Strategies such as family-centred care for newborns and zero separation of the mother and baby should be prioritized.Facility policies and administration should ensure that families have access to beds,food and bathing and toilet facilities throughout the infants facility stay,to enable family support and engagement in newborn care(66).These issues can be addressed through changes to policy-,facility-and community-level activities(43).Infrastructure requirements for reproductive,maternal,newborn and child health,including:clean,appropriately illuminated,well venti-lated labour,childbirth and neonatal areas that allow for privacy and are adequately equipped and maintained;clean and accessible bathrooms for use by women in labour;curtains,screens,partitions and sufficient bed capacity and facilities for labour companions,including physical private space for the woman and her companion(Global;41)For example,improve facility infra-structure,including establishing a waiting room for pregnant and labouring mothers,screens or curtains to maintain privacy,bathroom and toilet with a door and handwashing sink with soap and water(Ethiopia;60)Supplies and equipment require-ments for reproductive,maternal,newborn and child health including:provisions for staff in the labour ward(e.g.refreshments);a standard informed consent form;information(written or pictorial,e.g.as leaflets)for the woman and her companion;essential medicines and basic adequate equipment for labour and childbirth available in sufficient quantities at all times in labour and childbirth areas(Global;41)45Drivers addressed:Policy requirementsDrivers addressed:Improve the facility and work environment Promote labour companionship and family involvement in newborn care Guidance on making health services adolescent-friendly,including dimensions of quality health services for adolescents(i.e.equitable,accessible,acceptable,appropriate,effective)(Global;62)For example,implementation of the Adolescent Champion Model to help primary care sites become more adolescent-centred;including a multi-disciplinary champion team trained on adolescent-centred care,and policy,attitudinal and infrastructure changes to facilities to make them more adolescent-friendly,especially regarding confidentiality(USA;63)Ensure that work processes and organizational management include a manageable workload and working conditions,with adequate facilities,a decent working environment (including water and electricity)and the availability of medications,supplies,equipment,management and treatment guidelines(Global;61)Training and education gapsWork environment Training and education gapsRecommendation:a companion of choice is recommended for all women throughout labour and childbirth(Global;43)Facilitating a womans choice with regard to a birth companion is an important component of reproductive,maternal,newborn and child health and is in accordance with a human rights-based approach(Global;42)Resource requirements for labour companionship include:staff time to manage the labour companion service;orientation sessions on supportive companionship techniques for companions;information,education and communication materials on supportive techniques;private physical space for the woman and her companion at the time of birth;and time to train the companion of choice to provide support(Global;41)An educational intervention to promote childbirth companions to improve clinical outcomes and quality of care,including:a workshop for maternity staff with an interactive workbook;posters and banners encouraging women to bring a companion;illustrated pamphlets for staff and pregnant women to show how companionship could be promot-ed locally and a magazine-style video on birth companionship (South Africa;68)Integration of a tailored compan-ionship model into public hospitals,including:(i)identification of a female relative as labour companion by women;(ii)provision of information,education and communication materi-als to women and companions;and(iii)allowing companions to accompany women throughout the first stage of labour(Egypt,Lebanon,Syria;67)Resources Resources 50 Compendium on respectful maternal and newborn care 51Deepening understanding of the drivers and areas of intervention to end mistreatmentProtecting the health,safety and well-being of health workers contributes to improving their productivity,job satisfaction and retention.Health workers have the right to safe and healthy working conditions to protect their own health.However,they often face risks from infections,hazardous substances,psychosocial stress,violence and inadequate sanitation(43).The COVID-19 pandemic reinforced the importance of health-worker mental health,prompting organizations such as WHO and the Interna-tional Labour Organization to issue recommendations for safeguarding their rights and well-being(6972).This period also sparked renewed interest in self-care and coping strategies,with interventions such as peer-support programmes designed to bolster resilience,and coping mechanisms,including in humanitarian settings(46,73,74).Recommendations for individual interventions for the promotion of positive mental health and prevention of mental health conditions:Universal interventionsUniversally developed psychosocial interventions that aim to build workers skills in stress management may be considered for workers to promote positive mental health,reduce emotional distress and improve work effectiveness Opportunities for leisure-based physical activity may be considered for workers to improve mental health and ability to workIndividual interventions for health,humanitarian and emergency workers Universally delivered psychosocial interventions that aim to build workers skills in stress management may be considered for health,humanitarian and emergency workers to promote positive mental health and reduce emotional distress Psychosocial interventions may be made available for health,humanitar-ian and emergency workers who are experiencing emotional distress Individual interventions for workers with emotional distress For workers with emotional distress,psychosocial interventions such as those based on mindfulness or cognitive behavioural approaches,or problem-solving training,may be considered to reduce these symptoms and improve work effectiveness For workers with emotional distress,physical exercise,such as aerobic training and weight-training,may be considered to reduce these symptoms(Global;72)The WHO global health and care-worker compact(i.e.the Global Care Compact)complies with inter-national laws and regulations and includes a framework for action with recommendations and policy actions on:preventing harm,providing support,promoting inclusivity and safeguarding the rights of health and care workers(Global;72)Occupational health and safety programmes for health workers At national level,this can include,for example,a policy statement on occupational health and safety issued and communicated to all workplace levels,and/or a unit/person in the Ministry of Health in charge of the occupational health and safety of health workersAt facility level this can include,for example,focal points for occupational health and safety designated and trained in all health facilities,a regular training programme and safety brief-ing plan for all health workers,regular risk assessments and prevention and mitigation of occupational hazards)(Global;70)Ensure fair salaries and salary incen-tives are consistently paid,including hardship allowances and family and lifestyle incentives(such as housing and education allowances),with formal employment contracts that state clear roles and expectations(Global;72)Ensure that the rights of health workers are fully protected,respected and fulfilled and that health workers are free from discrimination and violence in the workplace(Global;44,45)Peer support to empower and enhance resilience and morale among nursing staff can include off-site reflec-tive sessions and post-work huddle sessions to discuss negative feelings and/or job stress(the Huddling Programme)(Republic of Korea;75)Caring for carers group or individual counselling to support providers with coping mechanisms to overcome experiences of high workload,trauma and critical incidents(part of a multi-component package,the Heshima project)(Kenya;46)6Drivers addressed:Support the well-being of health workers Recommendations for organizational interventions for the promotion of positive mental health and prevention of mental health conditions:Universal interventionsOrganizational interventions that address psychosocial risk factors,including those involving participatory approaches,may be considered for workers to reduce emotional distress and improve work-related outcomesOrganizational interventions for health,humanitarian and emergency workersOrganizational interventions that address psychosocial risk factors,for example reductions to workload and schedule changes or improvement in communication and teamwork,may be considered for health,humanitarian and emergency workers to redu
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Target product profiles for tuberculosis screening testsTarget product profiles for tuberculosis screening testsTarget product profiles for tuberculosis screening testsISBN 978-92-4-011357-2(electronic version)ISBN 978-92-4-011358-9(print version)World Health Organization 2025Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence(CCBY-NC-SA3.0IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy of this translation.The original English edition shall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization(http:/www.wipo.int/amc/en/mediation/rules/).Suggested citation.Target product profiles for tuberculosis screening tests.Geneva:World Health Organization;2025.Licence:CCBY-NC-SA3.0IGO.Cataloguing-in-Publication(CIP)data.CIP data are available at https:/iris.who.int/.Sales,rights and licensing.To purchase WHO publications,see https:/www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing,see https:/www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables,figures or images,it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder.The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.Design by Inis Communication iiiContentsAcknowledgements ivAbbreviations and acronyms viExecutive summary vii1.Introduction 11.1 Objectives and target audience 11.2 Background 21.3 WHO guidance on systematic TB screening and its implementation 32.Methodology 52.1 Previous WHO TPP values for TB screening 52.2 Establishment of the Scientific TPP Development Group 62.3 Guiding principles for the development of TPPs for TB screening 62.4 Screening algorithms 72.5 Modelling of required accuracy of screening tests 72.6 Profiles of screening tests 82.7 Delphi-like process 102.8 Public consultation and comment process 102.9 Scientific TPP Development Group final consultation 103.Target product profiles 114.Other considerations 175.Conclusion 19References 21Annex 1.Overview of the results of the Delphi-like consultation and WHO public comment process for the TPP for TB screening tests 23Target product profiles for tuberculosis screening testsivAcknowledgementsThis document on target product profiles(TPPs)was prepared by staff of the World Health Organization(WHO)Global Programme on Tuberculosis&Lung Health(WHO/GTB)namely,Cecily Miller,Dennis Falzon and Nazir Ismail under the guidance of Matteo Zignol and the overall direction of Tereza Kasaeva,Director of WHO/GTB.WHO thanks the members of the Scientific TPP Development Group for their contribution(in alphabetical order):Chukwuma Anyaike(National TB,Leprosy and Buruli Ulcer Control Programme,Nigeria),Helen Ayles(London School of Hygiene&Tropical Medicine LSHTM,United Kingdom of Great Britain and Northern Ireland United Kingdom),Ramon Basilio(National TB Reference Laboratory,Research Institute for Tropical Medicine,Philippines),David Branigan(Treatment Action Group,United States of America USA),Adithya Cattamanchi(University of California,Irvine,USA),Daniela Maria Cirillo(WHO Collaborating Centre and TB Supranational Reference Laboratory,San Raffaele Scientific Institute,Italy),Frank Cobelens(University of Amsterdam,Netherlands),Jacob Creswell(Stop TB Partnership),Claudia M.Denkinger(University of Heidelberg,Germany),David Dowdy(Johns Hopkins Bloomberg School of Public Health,USA),Petra de Haas(KNCV Tuberculosis Foundation,Netherlands),Rumina Hasan(Aga Khan University,Pakistan and LSHTM,United Kingdom),Cathy Hewison(Mdecins Sans Frontires,France),Jamilya Ismailova(Abt Associates,Civil Society Representative,Tajikistan),Davaalkham Jagdagsuren(Mongolia National Centre for Communicable Diseases,Mongolia),Rajendra Panduranga Joshi(Ministry of Health and Family Welfare,India),Gulmira Kalmambetova(National TB Programme NTP,Kyrgyzstan),Jacqueline Kisia(NTP,Kenya),Katharina Kranzer(LSHTM,United Kingdom),Rhea Lobo(independent health journalist,Denmark),Peter MacPherson(University of Glasgow,United Kingdom),Sandeep Meharwal(FHI 360 Asia Pacific Regional Office,Thailand),Paolo Miotto(WHO Collaborating Centre and TB Supranational Reference Laboratory,San Raffaele Scientific Institute,Italy),Troy Murrell(Clinton Health Access Initiative,USA),Ruvandhi Nathavitharana(Harvard Medical School,USA),Norbert Ndjeka(Department of Health of South Africa,South Africa),Van Hung Nguyen(National TB Reference Laboratory,National Lung Hospital,Viet Nam),Mark Nicol(University of Western Australia,Australia),Rustam Nurov(NTP,Tajikistan),Shaheed Vally Omar(National Institute for Communicable Diseases,WHO Supranational TB Reference Laboratory,South Africa),Madhukar Pai(McGill University,Canada),Tiffany Tiara Pakasi(NTP,Indonesia),Zhi Zhen Qin(Stop TB Partnership,Switzerland),Paulo Redner(National TB Reference Laboratory,Oswaldo Cruz Foundation,Brazil),Andriansjah Rukmana(University of Indonesia,Indonesia),Anastasia Samoilova(National Medical Research Centre on Phthisiopulmonology and Infectious Diseases,Russian Federation),Mahafuzer Rahman Sarker(TBLeprosy and AIDS/STD programme,Bangladesh),Siva Kumar Shanmugam(National Institute for Research in TB,India),Thomas Shinnick(independent laboratory consultant,USA),Nicole de Souza(NTP,Brazil),Willy Ssengooba(Department of Medical Microbiology,Makerere University,Uganda),Sabira Tahseen(National TB Reference Laboratory,Pakistan),Diana Vakhrusheva(National Medical Research Centre of Phthisiopulmonology and Infectious Diseases,Russian Federation),Dinh Van Luong(National Lung Hospital,Viet Nam)and Zhao Yanlin(National Center for Tuberculosis Control and Prevention,China).Special thanks to Alexandra de Nooy and Tom Ockhuisen(University of Amsterdam,Netherlands)for carrying out the modelling work used to inform this current update,and to Mikashmi Kohli,Brooke Nichols,Morten Ruhwald,Nick Banks and Olukunle Akinwusi(Foundation for Innovative New Diagnostics,Switzerland)for their input during the process of updating this TPP.WHO acknowledges the participation of observers from technical,development and regulatory agencies,including Grania Brigden(Global Fund to Fight AIDS,Tuberculosis and Malaria,Switzerland),Puneet Dewan(Bill&Melinda AcknowledgementsvGates Foundation,USA),Anisa Ghadrshenas(Unitaid,Switzerland),Brian Kaiser(Global Drug Facility,Switzerland),Helen Rees(South African Health Products Regulatory Authority,South Africa),Sella Senthil(Central Drugs Standard Control Organisation CDSCO,India),Venugopal Girdharilal Somani(CDSCO,India),Wayne Van Gemert(Stop TB Partnership,Switzerland)and Aihua Zhao(National Institutes for Food and Drug Control,China).WHO also acknowledges the participation of additional members of the WHO Secretariat:Saskia den Boon,Patricia Hall-Eidson,Alexei Korobitsyn,Carl-Michael Nathanson and Samuel Schumacher(WHO/GTB),Corinne Merle(Special Programme for Research and Training in Tropical Diseases),Mark Lanigan,Anne-Laure Page,Irene Prat and Uta Strher(Regulation and Prequalification),Jean de Dieu Iragena(WHO Regional Office for Africa),Ernesto Montoro(WHO Regional Office for the Americas),Kenza Benani and Martin van den Boom(WHO Regional Office for the Eastern Mediterranean),Soudeh Ehsani(WHO Regional Office for Europe),Vineet Bhatia(WHO Regional Office for South-East Asia),and Kyung Hyun Oh and Kalpeshsinh Rahevar(WHO Regional Office for the Western Pacific).The contributions of all individuals who provided input through the online public call for comments to support the development of this TPP are also gratefully acknowledged.Target product profiles for tuberculosis screening testsviAbbreviations and acronymsCADcomputer-aided detection of TB on digital chest radiographyCDRcase detection rateCRPC-reactive proteinCXRchest X-ray or radiographyGTBWHO Global Programme on Tuberculosis&Lung HealthHIVhuman immunodeficiency virusIGRAinterferon gamma release assayNTPnational TB programmeTBtuberculosisTPPtarget product profileTPTTB preventive treatmentWHOWorld Health OrganizationXpertXpert MTB/RIF UltraviiExecutive summaryIn 2023,over 8.2million cases of tuberculosis(TB)were detected and notified to the World Health Organization(WHO);nevertheless,an estimated 2.6million people who developed TB in that year were not detected(1).In light of this persistent gap in case detection and sustained high TB incidence,systematic TB screening is an essential intervention to find and treat people with TB who are missed by the health system,and thus reduce transmission and prevalence of TB.However,if TB screening is to be implemented at the levels needed to significantly reduce the global TB burden,there is an urgent need for new tools for TB screening that can be readily and rapidly deployed and brought to scale.WHO first published target product profiles(TPPs)for a test to improve the early detection of TB in 2014.The goal was to spur the development of novel tools that could detect a significant proportion of prevalent TB cases while also reducing the volume of individuals going on for diagnostic evaluation with rapid molecular testing(2).In the decade since the first TPPs were released,there have been significant and rapid advancements in screening technology,including mobile and even portable digital radiographic equipment,alongside innovations driven by artificial intelligence(AI)in computer-aided detection software,which can provide automated interpretation of chest X-ray for TB screening,anywhere and at any time.These advancements,matched with the wider availability of molecular diagnostic tests,have enabled impressive scaling up of screening in many high TB burden settings.Despite the advances,important challenges remain in bringing screening to the scale needed to close the case detection gap and reduce the TB burden globally.Foremost among these challenges are the availability of screening tools with the low cost and high accuracy required to conduct screening in lower prevalence populations,such as those encountered in community-based screening activities.There has been a growing recognition that the burden of undiagnosed prevalent TB is larger than previously realized,and that a substantial portion of TB is likely to be asymptomatic(3),underscoring the need for community-based screening activities using symptom-agnostic tools to substantially reduce the burden of TB.In addition,better tools for differentiating TB from other pulmonary conditions to enable rapid diagnosis and treatment are still needed for screening in health facilities and similar higher prevalence settings.The process of updating these TPPs for screening tools was undertaken to bring the document in line with the needs of end users and with the strategic priorities of WHO,including the End TB Strategy,which promotes systematic screening as part of the first pillar of patient-centred care and prevention(4).This updated TB screening TPP document was developed with input from a multidisciplinary expert advisory group.The process included a Delphi-like consultation to achieve consensus,and guidance from many stakeholders from various fields who provided feedback through an open public call for input.For the updating,modelling was conducted to inform the expert discussions about the impact of test accuracy on the performance of screening algorithms,and the resulting requirements for diagnostic testing and associated programme costs.Target product profiles for tuberculosis screening testsviiiA core update in this document is the inclusion of three distinct types of screening tools that may be effective in implementing TB screening in different settings,prevalences and situations:a high-sensitivity,high-specificity screening test that can be implemented as a single screening step before referral for diagnostic testing or effective ruling out of TB;a high-sensitivity screening test to be implemented as part of a two-step screening approach(i.e.in combination with another screening test)before referral for diagnostic testing;and a screening test with moderate sensitivity but high specificity,which can be deployed in settings and situations that have limited access to health systems and cannot be reached by existing screening tools,to improve case detection and access to care in underserved areas and populations.The TPPs described in this document are intended to provide product-and technology-agnostic guidance,and to encompass all possible approaches used for screening.Any newly developed technology that can meet most or all of the product profile characteristics could be considered for use in screening,if proven effective.It is hoped that these updated TPPs for novel TB screening tests can inform key stakeholders in research and development,and spur further innovation in this key area for global TB care.References for the Executive summary1.Global tuberculosis report 2024.Geneva:World Health Organization;2024(https:/iris.who.int/handle/10665/379339).Licence:CC BY-NC-SA 3.0 IGO.2.Meeting report:high-priority target product profiles for new tuberculosis diagnostics:report of a consensus meeting(WHO/HTM/TB/2014.18).Geneva:World Health Organization;2014(https:/apps.who.int/iris/bitstream/handle/10665/135617/WHO_HTM_TB_2014.18_eng.pdf).3.Frascella B,Richards AS,Sossen B,Emery JC,Odone A,Law I et al.Subclinical tuberculosis disease a review and analysis of prevalence surveys to inform definitions,burden,associations,and screening methodology.Clin Infect Dis.2021;73:e830e41(https:/doi.org/10.1093/cid/ciaa1402).4.The End TB Strategy website.Geneva:World Health Organization;2014(https:/www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/the-end-tb-strategy).11.IntroductionDespite being a preventable and curable infectious disease,tuberculosis(TB)has continued to elude global control efforts.In 2023,8.2million people with TB were diagnosed and notified to the World Health Organization(WHO),the highest number ever reported since WHO began tracking;yet these cases still represent only three quarters of the estimated 10.8million incident TB cases for that year(1).Given the persistence of the global TB epidemic,and to achieve the targets of the End TB Strategy(2),there is an urgent need to deploy strategies to improve case detection for people with TB globally,especially among communities and populations with prevalent undetected TB,and groups or areas lacking adequate access to care.One key strategy is systematic screening for TB disease.TB screening is a central component of the first pillar of the End TB Strategy,aimed at ensuring early diagnosis for all people with TB(3,4).There are two primary objectives of screening for TB disease:to ensure that TB disease is detected early and treatment is initiated promptly among those at high risk for TB,to improve health outcomes and reduce the risk of morbidity,mortality,and the adverse social and economic consequences of TB;and to reduce population prevalence of TB disease,thus reducing transmission of Mycobacterium tuberculosis and averting future incident TB disease.Additionally,TB screening can help to bolster TB case detection in areas where it is suboptimal,and identify individuals eligible for TB preventive treatment(TPT)once TB disease is ruled out,thus further minimizing incident TB.Tests for TB screening are essential to implement screening interventions effectively and at scale.The development of target product profiles(TPPs)for novel TB screening tests helps to ensure that developers align with the needs of the global TB community when developing new products for the next generation of TB screening tests and tools.1.1 Objectives and target audienceWHO TPPs are strategic reference documents that are intended to facilitate and accelerate the development of medical products and devices addressing the greatest and most urgent public health needs.In terms of tests for TB screening,the overall objective of TPPs is to align developers performance and operational characteristics with the needs of users.The objective of this document is to inform test manufacturers,researchers and research funders about the nature and significance of new tools for screening for TB disease and the relevant implications for the development of new diagnostic technologies.This document defines key TPP specifications,such as the target population,performance,operational characteristics and pricing.Any newly developed technology that can meet most or all of the product profiles could be considered for screening use,if proven accurate and advantageous.The TPPs described in this document are intended to be product-and technology-agnostic,and to encompass all possible approaches used for screening.WHO will not Target product profiles for tuberculosis screening tests2publish separate TPPs for specific screening technologies or products such as computer-aided detection(CAD)software for chest X-ray(CXR)reading or C-reactive protein(CRP)assays.The target audience for this TPP comprises test developers and manufacturers interested in entering the TB screening test market,regulatory agencies,academia,research institutions,product development partnerships,nongovernmental organizations(NGOs),civil society organizations and donors.1.2 BackgroundSystematic screening for TB disease is defined as the systematic identification and evaluation of people at risk for TB disease,in a predetermined target group,using tests,examinations or other procedures that can be applied rapidly.Screening can be conducted in a single step or in multiple steps.A positive or abnormal result on a screening test indicates that the individual should undergo evaluation with a WHO-recommended rapid diagnostic test(WRD)to confirm a diagnosis of TB,or to rule out the disease and investigate alternate causes for the abnormal test result.A negative or normal result on a screening test indicates that TB disease can effectively be ruled out and the individual can be referred for TPT if eligible.To achieve the primary objectives of screening,including protecting individuals at high risk and reducing community burden of disease,a screening test must be able to:distinguish individuals who have a higher likelihood of having TB(and who should thus go on to further diagnostic testing)from those who are unlikely to have TB;and ensure an adequate pretest probability of TB among people being referred for confirmatory testing.1Confirmatory tests typically cost more than screening tests;hence,a screening step is needed to identify who should undergo further diagnostic testing,to ensure prudent use of resources.TB screening has fallen into and out of favour globally over the past century.For much of the early 20th century,in many high-resource countries where TB was still a leading cause of death,mass community-wide screening using CXR was routinely conducted(5,6).Many of these mass screening campaigns were successful at detecting a large number of people with prevalent TB,and some found a substantial reduction of community TB prevalence in follow-up activities(7).Later in that century,once TB was no longer a major cause of death in western countries,interest in screening waned and mass TB screening campaigns were discontinued in much of the world;however,some countries in Eastern Europe continued population-wide TB screening(8).Since the early 2000s,interest in screening has been renewed,with a particular emphasis on protection and care for the most vulnerable groups.Screening for TB in groups at highest risk was first emphasized in 2011,with WHO recommendations for screening people living with HIV;this was followed in 2012 by recommendations for screening of close contacts of people with TB,and in 2013 by consolidated guidance for screening of high-risk groups(911).Around that time,more sensitive and decentralizable diagnostic tools became available,with the advent of automated nucleic acid tests for TB(12).One factor that has driven interest in more broad-scale screening is the revelation of the magnitude of prevalent,undetected TB;in particular,the fact that a substantial portion of such TB is asymptomatic(13).National TB prevalence surveys over recent years have consistently found that about half of prevalent TB detected in the community is bacteriologically confirmed among people who do not report symptoms of TB disease(14).Asymptomatic TB is a substantial challenge to a system of care based on passive case detection,and it requires a more active case-finding approach(15).Recognition of the contribution of 1 Diagnostic tests are typically performed among a population of individuals who are ill and seeking care,and their performance and the interpretation of the results are designed for a population with a higher pretest probability of TB than the overall screening population.1.Introduction3asymptomatic TB to the overall TB burden also highlights the urgent need for better tools for screening for TB disease that are not based on symptom status(16).The rapid advancement of technology in recent years has brought about great innovations in TB screening,including digital radiography with mobile and portable options,and CAD software programmes for automated interpretation of CXR imaging for TB screening(17).Artificial intelligence(AI)holds enormous promise for continuing and accelerating the development of new tools and technologies for TB screening.Alongside this,developments in TB diagnostics have greatly expanded the available options to test people who screen positive.This document is designed to help ensure efficient and effective progress in developing the next generation of TB screening tools.1.3 WHO guidance on systematic TB screening and its implementationThe current WHO guidance recommends screening for TB among high-risk groups and in targeted geographies or communities with higher risk of TB,in both facility-based and community-based screening interventions.Screening is strongly recommended for four risk groups who are at highest risk of TB and of poor outcomes from the disease:household and close contacts of TB patients,people living with HIV,prisoners and those who reside or work in penitentiary institutions,and miners with silica exposure.Screening is also strongly recommended for children who are contacts of TB patients or living with HIV.For these risk groups,screening is recommended across all global settings(18).Screening is conditionally recommended in facilities and health care settings among people seeking care who have risk factors for TB,in areas with a TB prevalence of 0.1%or higher,and among people with fibrotic lesions identified on CXR.Community-based screening is recommended in the general population in areas with a very high TB prevalence(0.5%)or among specific populations with a high risk of TB and limited access to health care;examples of such populations are urban poor communities,homeless populations,remote or isolated communities,indigenous populations,migrants,refugees and internally displaced populations(18).Currently,WHO recommends various tools for screening.Symptoms can be used for screening in any population;however,there are limitations in accuracy,and the ability to detect asymptomatic TB is lacking.CXR can be used to screen most populations and has the best demonstrated sensitivity of available screening tools.CAD software for automated interpretation of CXR imaging can be used alongside CXR for screening all adults aged 15years and older;such software greatly increases the ability to implement screening at scale globally,given the limited availability of radiologists or even physicians in many settings.Molecular WHO-recommended rapid diagnostic tests for TB are also recommended for screening all adults,and CRP can be used to screen adults living with HIV(18).The different populations targeted for screening require very different modalities for screening tools.Facility-based screening can use stationary laboratory and imaging equipment,such as stationary CXR or quantitative CRP assays;in contrast,community-based or household-based screening requires mobile or portable devices that can be implemented in various conditions(19).Portable radiology equipment combined with CAD software has enabled the implementation of screening to a broader extent than has previously been achieved;however,the ability to scale up community-based screening to the most hard-to-reach areas and to adequate coverage levels is still limited by a lack of tools that can be easily transported and implemented across all possible settings and environments.In addition,some populations that require screening to improve case detection are particularly challenging to diagnose(e.g.people living with HIV or children at high risk of TB).The detection of childhood TB is an important global health need;hence,a test that improves the quality of diagnosis and overall case detection in children will have significant benefits for TB programmes.Therefore,manufacturers should try to expand their initial validation studies and include children,wherever possible.52.MethodologyIn line with WHO methodology for development of TPPs,the update of the WHO TPPs for novel screening tests followed a consultative process that included a multidisciplinary group of experts and input from a wide range of stakeholders.The revised TPPs underwent a Delphi-like consultation and subsequent revision following several rounds of feedback and consultations.The draft TPPs were also made available for public comment on the WHO website before being finalized through a consultation that incorporated all the feedback gathered throughout the process.2.1 Previous WHO TPP values for TB screeningPrevious TPP values applied for TB screening were based on the desired accuracy of a point of care triage test,as published by WHO in 2014(3).Since then,there has been a significant expansion of interest in broader TB screening interventions,targeting larger populations with lower TB prevalences.The release in 2021 of the updated WHO guidelines on systematic TB screening expanded the recommendation for community-wide screening from 1%prevalence settings to 0.5%prevalence settings,based on evidence of reduction of prevalence and transmission(18,20).Beyond research,several countries are undertaking much larger scale community-based screening initiatives as part of efforts to reach the End TB Strategy targets of reducing TB incidence by 90%by 2030,and the United Nations high-level meeting targets of detecting and treating 90%of people with TB by 2027(21).Examples of such initiatives include the Community Awareness,Screening,Testing,Prevention and Treatment for TB(CAST-TB)campaign of community-wide education and screening activities in high TB burden communities in Uganda,and the Double X screening campaign that combines CXR screening and Xpert MTB/RIF Ultra testing of people with TB risk factors in Viet Nam(2,16).Therefore,the focus of the current document has expanded to include more emphasis on effective community-based screening at larger scale in lower TB prevalence settings and populations.This necessitates the development of new screening tools and technologies that can enable such community-based screening interventions in a cost-effective and scalable way,while maintaining high accuracy to minimize the risk of overdiagnosis.This expansion of scope does not lessen the importance of developing new tools that can effectively be used to screen populations in poorer health and with a relatively higher TB prevalence,often within health facilities or among people seeking care.The screening of populations and risk groups in health facilities is an essential component of the WHO screening recommendations.For this updated document,the term“triage”has been replaced with“screening”,given that both represent a screening intervention targeted to a specific risk group.The distinction lies only in the population being screened,whether it be a community-based population of largely healthy individuals with low TB prevalence,or a facility-based group of people either in hospital or seeking care,in settings with a higher prevalence of TB.Target product profiles for tuberculosis screening tests62.2 Establishment of the Scientific TPP Development GroupA Scientific TPP Development Group was established for this update of the TPP for screening tests,alongside a process of updating the TPPs for diagnostic tests for TB(22).The group comprised experts from high and low TB burden settings,with experience in microbiology,mycobacteriology,molecular biology,health systems,pricing,procurement and regulation of medical devices.The group also had balanced geographical and gender representation,and included infectious disease specialists and scientists or researchers with a strong background and experience in TB diagnostics.In addition,to ensure that the perspectives and needs of TB patients and their communities were considered,representatives from civil society organizations participated in the process.All members of the Scientific TPP Development Group participated in their individual capacity(i.e.they did not represent any external entity,authority or government).In compliance with the WHO standard procedures for declaration and assessment of interests,all members of the group were required to disclose any financial interests,relationships or activities that may be perceived as influencing their objectivity or decision-making in the context of the present work.All members therefore completed a WHO declaration of interest form and underwent an online background assessment to identify relevant matters that could give rise to a real or perceived conflict of interest,and that may have gone unnoticed or not reported during earlier assessments.Additionally,all experts were instructed to notify WHO of any change in relevant interests during the process.No significant conflicts of interest were noted for any of the members of the Scientific TPP Development Group.2.3 Guiding principles for the development of TPPs for TB screeningAn ideal screening test is one that is easy to conduct;does not require invasive sampling,extensive training or resources;and has a short turnaround time to enable rapid clinical decision-making.Tools for TB screening have traditionally had an emphasis on high sensitivity for detecting TB,the goal being to maximize TB case detection.There has been less focus on specificity,given that a positive screening test is usually followed by a diagnostic evaluation and further testing to either confirm or rule out a diagnosis.However,the challenges of implementing screening with a high-sensitivity,low-specificity test include the testing burden and associated expenses of conducting confirmatory tests for all who screen positive.These challenges compound as screening is expanded and implemented in lower prevalence settings.Therefore,for the purposes of this updated TPP,tests with a wide range of performance characteristics were explored for their potential utility in screening.Accuracy for TB screening tools has typically been evaluated against a microbiological reference standard,to determine the tools performance in detecting bacteriologically confirmed TB.However,a composite reference standard incorporating unconfirmed diagnosis may sometimes be appropriate,for example,when considering:screening of populations in which obtaining a bacteriological confirmation is difficult and a diagnosis is often established by clinical evaluation(e.g.children or people living with HIV);or the accuracy of screening tests being conducted in a population that often cannot produce a sputum sample required for laboratory testing,such as screening in a healthy population with a very low burden of TB and other lung conditions.Above all,a screening test must be affordable and scalable,to enable implementation of screening interventions at the scale required to reduce the population level prevalence and transmission of TB in high-burden areas.Such characteristics could be achieved by screening activities using tests that have a small per-test cost and little to no equipment or capital investments.Tests that require more centralized equipment for processing would need to achieve low per-test costs and implementation requirements overall,taking into account expenses for transportation of samples and transmission of results.2.Methodology72.4 Screening algorithmsScreening tests are not performed in isolation;they are conducted in algorithmic combination,sometimes with other screening tests and always concluding with diagnostic testing.The ideal would be to have a single screening step before referral for diagnosis,but sometimes multiple screening steps are required to achieve the defined objectives of screening in very low prevalence settings.Multiple screening tests conducted in parallel result in a screening step with higher sensitivity and lower specificity than any single test on its own.Multiple screening tests conducted serially,with a positive or abnormal result on a first screening test leading to a subsequent screening step before diagnostic confirmation,can greatly reduce the overall volume of people referred for diagnostic evaluation,though with some loss to sensitivity.Screening based on symptoms or signs of TB should NOT be an initial step in such an algorithm,because individuals with signs or symptoms of TB should always go directly to diagnostic evaluation without further screening(23).Additional screening algorithm options are described in the“WHO operational handbook on tuberculosis:module 2:screening:systematic screening for tuberculosis disease”(19).In this TPP document,the performance of novel screening tests was considered within a screening algorithm,and the performance of the algorithm as a whole was modelled.Both a single screening test algorithm and a two-step positive sequential algorithm were modelled.Although there was no explicit modelling of parallel or negative sequential screening algorithms,the performance of either of these algorithms can be represented by a single screening step algorithm,with the combined accuracy of two tests performed in parallel or negative sequential succession.2.5 Modelling of required accuracy of screening testsFor the performance aspect of this screening TPP document,modelling was conducted to determine what levels of accuracy(i.e.sensitivity and specificity)are required from a screening test to achieve the objectives of screening.The parameters required of a screening test and algorithm were set as follows:The screening algorithm as a whole comprising one or more screening tests and a diagnostic evaluation should detect at least 60%of the prevalent TB cases in the population being screened(for one option,an exception was made and a 50%minimal case detection was considered).The screening test or tests should result in a post-screen prevalence of TB of 5%among the population that has screened positive and is being referred for diagnostic testing.This is representative of the pretest probability of TB for which diagnostic tests for TB have been evaluated;thus,it ensures that the results of the diagnostic tests can be interpreted as intended.The initial prevalence of TB in the population being screened should be representative of the populations in which TB screening is currently recommended and in which screening needs to be scaled up globally.Given the current WHO recommendations for screening and the need for tools that can enable broader scale screening in lower prevalence settings,the minimum requirements were set for tools that can achieve the above parameters in populations with a TB prevalence down to 1%,and the optimal requirements were set to a prevalence of 0.25%.Modelling was conducted to assess the required accuracy for novel TB screening tools by fixing one parameter of accuracy and estimating the requirements in the other parameter(i.e.fixing sensitivity and estimating specificity,or vice versa)to achieve the above targets for case detection and post-screen prevalence.Novel screening tests were modelled as part of a single step or sequential algorithm,implemented in various TB prevalence settings ranging from 1%down to 0.1%.Target product profiles for tuberculosis screening tests82.6 Profiles of screening testsThe results of the modelling performed to inform this updated TPP document illustrated the challenges inherent in screening very low prevalence settings;they also highlighted a range of different screening approaches that could achieve the required parameters of the model in most settings.No hypothetical test in the model could achieve the required parameters for screening in a single or two-step serial algorithm in settings with a 0.1%prevalence.In settings with a prevalence of TB of 0.25%or higher,three possible approaches to screening emerged that achieved the requisite screening parameters.These approaches correspond to three different profiles of possible novel screening tests(see Fig.2.1):A high-sensitivity,high-specificity screening test as a single screening test:Such a test could be implemented as a single screening test algorithm and would result in the highest case detection from all scenarios presented here;however,it has the highest requirements for accuracy.A high-sensitivity screening test in a two-step screening algorithm:Such a test would lessen the requirement for specificity by employing a second screening test;however,the accompanying complexity and costs would need to be taken into account.A high-specificity screening test(with moderate sensitivity)as a single screening test:Such a test can achieve most of the required parameters for screening in a single screening step but would have lower case detection than the high-sensitivity screening approaches.However,such a novel screening test would only have value over currently available screening tools if it were low cost,easily implementable in a wide variety of environmental conditions and contexts,and able to be brought to scale to improve case detection in areas that are not currently well served.This would improve the standard of care for these populations.2.Methodology9Fig.2.1.Performance of three screening test types,conducted among a hypothetical population of 1000 people with a TB prevalence of 1%,within an algorithm that raises the prevalence of TB in the population being screened to at least 5%among individuals being referred for diagnostic evaluation,and detects at least 5060%of prevalent TB in the population.In the figure,each person is represented by a dot;green dots represent individuals without TB and red dots represent individuals with TBCXR:chest X-ray;TB:tuberculosis.Population to be screenedTest type 1:High-sensitivity,high-specificity screening testScreened population going for diagnostic evaluationPeople diagnosedwith TBNovel Screening testDiagnostic evaluation1000%of overall population%of individuals with TB20%1.2%Population to be screenedTest type 3:Moderate-sensitivity,high-specificity screening testScreened population going for diagnostic evaluationPeople diagnosedwith TBNovel Screening testDiagnostic evaluation1000%of overall population%of individuals with TB2.5%0.6P%Population to be screenedTest type 2:High sensitivity screening test followed by a second screening testPopulation going or second screening testScreened population going for diagnostic evaluationPeople diagnosed with TBNovel Screening testSecond screening test(e.g.CXR)Diagnostic evaluation1000%of overall population%of individuals with TB40.5r%0.9%Target product profiles for tuberculosis screening tests102.7 Delphi-like processAfter initial discussions,an early draft TPP document with modelling results was prepared and discussed among the Scientific TPP Development Group on 2September 2023.From October to November 2023,a Delphi-like survey was conducted within the Scientific TPP Development Group.For this process,one round of survey was conducted and the definition of consensus used was 80%agreement.Participants were asked to express their level of agreement on the proposed characteristics according to a predefined Likert scale ranging from 1 to 5(1:disagree,2:mostly disagree,3:neither agree nor disagree,4:mostly agree and 5:strongly agree).An 80%cut-off was set as the threshold to indicate agreement with the parameters outlined in the TPP during the Delphi-like process.Participants were also asked to provide comments in support of their score(particularly when they did not agree and scored a characteristic at 3 or lower).For characteristics where the consensus was less than 80%,qualitative comments from the group were collated and analysed to further refine the document.Overall,the outcomes of the Delphi-like process showed a high level of agreement for most of the attributes described in this TPP,with some areas being resolved through discussion leading to consensus.2.8 Public consultation and comment processA draft TPP document including the results of the Delphi-like survey and resulting updates was shared online for public commentary through the WHO Dataform system from 31January 2024 to 29February 2024.The intended audience for the document included TB programme managers,laboratory specialists,clinical practitioners,implementers,researchers,representatives of civil society organizations and industry,and patient advocates.Comments were analysed and incorporated into the final draft TPP document.Results of the public comment process are provided in Annex1.2.9 Scientific TPP Development Group final consultationA final consultation of the Scientific TPP Development Group was held on 46March 2024.Feedback received through the online public comment process and the outcomes of the Delphi-like consultation were presented during the consultation for each characteristic of the TPP.The discussions involved a detailed analysis of public feedback and proposed revisions.This inclusive approach fostered information sharing,facilitated the exchange of perspectives and allowed for clarification of various aspects;overall,it ensured a comprehensive and well-informed decision-making process.Changes and suggestions made during the stakeholder consultation were incorporated into the final TPPs presented in Section3.113.Target product profilesTable3.1 shows the minimal and optimal characteristics of novel tests for screening for TB.It is expected that potential screening products would meet all of the required minimum criteria of the“TPP for TB screening tools”,and as many of the optimal requirements as possible.However,potential trade-offs on performance,cost,impact and operational characteristics would need to be considered for WHO policy;thus,the criteria are indicative rather than absolute.Table 3.1.Minimal and optimal characteristics of novel tests for screening for TBCharacteristicMinimalOptimalExplanatory notesScopeIntended useTo provide characteristics for a test that can help identify people:presumed to have TB who require further active TB diagnostic evaluation;and unlikely to have TB and in whom the test can effectively rule out TB disease.Systematic TB screening is intended to be conducted among populations at risk of TB,irrespective of symptom status or clinical presentation,to identify individuals with presumptive TB.The goal of screening as described here is primarily to detect pulmonary TB.It is important to note that individuals presenting with signs or symptoms of TB should proceed directly to diagnostic evaluation using a WRD.Target populationPopulations and groups at risk of TB,down to 1%TB prevalence.Populations and groups at risk of TB,down to 0.25%TB prevalence.Values shown here reflect the results of modelling that informed the development of this TPP.The target populations here for minimal and optimal use cases reflect different scenarios in which screening may be conducted.The minimal test described here would be better suited for screening populations at higher risk(e.g.contacts)or facility-based screening,where TB prevalence tends to be higher;in contrast,the optimal test would be better suited for broad screening in communities and populations with lower risk.Screening is increasingly being implemented in lower TB prevalence settings,but the implementation is hindered by the performance of current tools.Manufacturers should endeavour to make tools that can perform more effectively in lower TB prevalence settings,described in the optimal use case here.Manufacturers should also aim to develop new screening tests that can be effective for screening among populations in whom existing screening tests do not perform as effectively,including among people living with HIV,pregnant women and paediatric populations of different age ranges.Target product profiles for tuberculosis screening tests12CharacteristicMinimalOptimalExplanatory notesIntended user of testHealth care worker or technician with some training in conducting TB screening tests.Laypeople or caregivers with minimal to no training or instruction required(can include self-testing).Community health workers are an important target user group for future screening tests,given the importance of community-based screening.SettingTests that can be performed in community settings,at health facilities with basic infrastructure(including electricity and water)and in household settings.Tests that can be conducted in community settings may also include self-tests that can easily be done in a household setting.For self-testing,it is critical that the test manufacturers also think about linkage to care,so that people can easily follow the care cascade.Where the screening test involves multiple steps(e.g.sample collection,processing and testing at a centralized facility),it is imperative that the first step in the workflow be simple and easy enough that it can be done in community settings as described.PerformanceTest accuracyTest accuracy characteristics are described for three distinct types of screening tests,corresponding to three possible approaches to screening,which achieve the required parameters of 5%post-screen TB prevalence and 60tectiona of all prevalent TB:a high-sensitivity,high-specificity screening test as a single screening test;a high-sensitivity screening test in a two-step screening algorithm;and a high-specificity screening test as a single screening test.Each of these screening approaches,with its associated screening test type,emerged from the modelling as an acceptable approach to achieve the required parameters of screening.A one-step screening approach using a high-sensitivity and high-specificity screening test would result in the highest case detection from all of the scenarios presented here it would be the most straightforward algorithm to implement but has the highest requirements for accuracy.A high-sensitivity,two-step screening approach lessens the requirement for specificity by employing a second(different)screening test.A novel test that is decentralized and scalable,even if not highly specific,would provide added value in such a screening scenario.The accuracy estimates provided for this approach are for one test in the algorithm.To model the performance of this approach,an exemplary additional screening test was used based on the estimated accuracy of CXR as a screening tool performed as a second screening test on a population pre-screened for symptoms(85%sensitivity and 70%specificity)(2427).The order of the two tests in the screening algorithm does not impact the accuracy of the algorithm as a whole,but does impact costs.It is important that screening based on symptoms or signs of TB should NOT be an initial step in such an algorithm,because individuals with signs or symptoms of TB should always go directly to diagnostic evaluation without further screening(23).A high-specificity screening test with lower sensitivity will have a lower case detection capacity overall and a high false negative rate.However,such a test can still have programmatic utility if it is affordable and easy to implement,with a possibility of achieving high population coverage,especially among hard-to-reach groups and areas that are not easily reached with current technology and health programmes.This approach did not achieve all the parameters desired,because in the minimal requirement space,the high-specificity test achieves only 50R.Test typeMinimal accuracybOptimal accuracycHigh-sensitivity,high-specificity screening test90%sensitivity80%specificity95%sensitivity95%specificityHigh-sensitivity screening test 90%sensitivity60%specificity95%sensitivity85%specificityHigh-specificity screening test 60%sensitivity98%specificity70%sensitivity98%specificitya One screening approach does not meet this level of CDR,as explained below.b Achieves the defined parameters in settings down to 1%prevalence,except for the high-specificity approach,which achieves 50R rather than 60R for minimal values.c Achieves the defined parameters in settings down to 0.25%prevalence.3.Target product profiles13CharacteristicMinimalOptimalExplanatory notesScreening tests should be evaluated against the best possible objective reference standard of TB status available;currently,in most cases this is a microbiological reference standard.Where a microbiological reference standard is not available or not optimal(e.g.in paediatric populations or people who cannot produce the necessary clinical specimen),an appropriate composite reference standard could be used,combining bacteriological testing with clinical and histological findings.In screening populations,many people will not be able to produce a sputum sample,which limits the ability to confirm the disease status.PricingPricing of individual test(reagent costs only,at scale and ex-works)Cost per testThe costs described here include the total cost per test,including ancillary costs(e.g.capital,consumables,equipment and maintenance costs of an instrument-based test)and excluding any shipping and import.Ideally,a new test should be priced according to the cost of goods and estimated volumes,and should include a reasonable profit margin.Ensuring access to tests while maintaining business interests can be achieved through fair pricing,which requires transparency about the cost of goods and estimated volumes,and a reasonable profit margin.The price of a test affects access and requires due consideration.It may be acceptable to have a more expensive screening test or a combination of tests if this improves overall accuracy,especially specificity,and thus reduces the volume of subsequent diagnostic testing required.However,a test may be considered unaffordable for some health programmes,even if studies have shown it to be cost effective.High-accuracy test(1 step)US$3US$1High-sensitivity test(2 step)US$2High-specificity testUS$2Operational characteristicsSample or specimen typeRequires easy-to-obtain samples,including non-physical samples such as imaging and sound.Does not require a physical sample,or requires an easy-to-obtain sample that is self-collectible.Easy-to-obtain samples include urine,tongue or oral swabs,saliva,exhaled breath and capillary blood.Non-physical samples such as CXR images and sounds are also included in this category.Manual preparation of samplesMinimal manual preparation at the site of collection,without strict timing or measurements.No manual preparation,strict timing or measurements.InstrumentPortable or mobile device that has an option of using battery or solar power for POC settings or a centralized instrument with highly efficient batch testing of samples.No instrumentation required.Ideally,if an instrument is needed,a single device is preferred but modular solutions would be acceptable(e.g.for separate sample processing and detection).For centralized testing,samples should be easy to collect onsite from remote settings and then easy to transport to a centralized facility with efficient batch testing.Target product profiles for tuberculosis screening tests14CharacteristicMinimalOptimalExplanatory notesTime to result 30 minutes20000 tests(whichever comes first);include maintenance alert.Maintenance not needed.Self or remote calibration.The frequency of preventive maintenance and calibration will be determined based on a combination of usage patterns,throughput,environmental factors and risk assessment findings.Units used more frequently may require more frequent maintenance and calibration to ensure consistent performance.Manufacturers should develop robust instruments or devices,considering that screening tests are intended to be conducted in large volumes,and that frequent preventive maintenance for the instrument might make uptake and implementation more onerous.Training and education1 day for staff with the skills to perform other health-related procedures.Minimal training or education.If a test involves specialized equipment or machinery,additional training time will be required to gain proficiency.For self-screening or where a user has no previous training on conducting any health-related procedures,a short,self-explanatory quick reference guide on performing the test should be sufficient.Documentation and display of results dataDigital readouts to display test details,including results.Ability to save results should be included,and results should be exportable in a standard format(e.g.XML or CSV)to a third-party instrument(e.g.via USB)or connectivity software.An instrument-free test with visual readouts(e.g.for barcodes)on a test device to digitally record and report data.Transmission of result data to the staff conducting screening should be digitized to enhance efficiency and linkage to care.Data storageThe administrative institution(MoH or NTP)managing sites where tests are deployed should be able to specify or agree with the storage location of the test data without affecting the support and optimal use of the test.Data governance policies(e.g.that ensure privacy protection,de-identification and anonymization)of test manufacturers and administrative institutions should align.Data ownershipTest data,their management and ownership must comply with local regulations.3.Target product profiles15CharacteristicMinimalOptimalExplanatory notesSecurity and privacyTo facilitate use by health programmes in accordance with the laws,regulations and policies in their settings and with best practices,the test should provide configurable features so that personal data can be:gathered with transparency for users and people who are taking the tests,including consent;collected and processed only for purposes compatible with the health programmes purposes;limited to what is relevant and necessary;collected accurately;stored in an identifiable form no longer than necessary;and secured for integrity and confidentiality,with encryption at rest and in transmission.Tests should adhere to internationally recognized standards for security of sensitive information.The bullet points are adapted from Article5,Section1 of the European Union General Data Protection Regulation(28).Regulatory requirementsDesign,development and manufacturing of the assay and system should comply with ISO13485 and ISO14971 or higher standards or regulations,and comply with ISO IEC62304.The manufacturing facility should be assessed at a high-risk classification and certified for use by one of the regulatory authorities of the founding members of the International Medical Device Regulators Forum(formerly known as the Global Harmonization Task Force).If applicable,the test must be registered for in vitro diagnostic use.For non in vitro diagnostic tests,appropriate regulatory requirements should be followed.See the following ISO publications:IEC 62304:2006 Medical device software software life cycle processes(29)ISO 13485:2016 Medical devices quality management systems(30)ISO 14971:2019 Medical devices application of risk management to medical devices(31)Language supportFor each country in which the test is deployed,instructions should be provided in one popular language;for example,the official language or de facto national language,and any language mandated by local regulatory or trade compliance requirements.Same as minimal plus additional languages that enable use by additional residents of the location of deployment.The instructions for use and screen instructions(if applicable)should also adhere to these language requirements.Including more languages will make a test more usable and acceptable.In designing tests,manufacturers should cater to the varying populations and different regional languages for the locations where the test is intended to be used.Target product profiles for tuberculosis screening tests16CharacteristicMinimalOptimalExplanatory notesOperating temperature,humidity level and storageBetween 5 C and 40 C with up to 70%humidity.Between 5 C and 50 C with up to 90%humidity.Countries where TB is endemic often have high environmental temperatures,dust,high humidity and flooding.Manufacturers should take this into consideration and carefully design the tests,keeping in mind the operating temperatures,environmental conditions and humidity levels that may be found in the intended settings.These considerations also apply to reagent storage and shelf life.Environmental impactTests and any associated instruments should minimize adverse impact on the environment;for example,by:having the potential to be produced locally;minimizing waste;maximizing the reusability and recycling of by-products;creating multi-use platforms;providing for recycling of instruments at the end of their life;and having low power consumption and radiation emissions.Manufacturers should provide clear and environmentally friendly guidance on disposal of used products and there should be no disposal of toxic waste.CDR:case detection rate;CSV:comma-separated values;CXR:chest X-ray;HIV:human immunodeficiency virus;MoH:ministry of health;NTP:national TB programme;POC:point of care;TB:tuberculosis;TPP:target product profile;UPS:uninterruptible power supply;USB:universal serial bus;WHO:World Health Organization;WRD:WHO-recommended rapid diagnostic test;XML:extensible markup language.174.Other considerationsThe TPPs presented here include the attributes that are considered essential for future tests for screening;that is,target population,target user of the test,setting,cost,accuracy and operational characteristics.It may be difficult for a single test to satisfy all of these characteristics.Thus,manufacturers may have to consider trade-offs,whereby a novel test has some clear advantages that may offset other downsides.For example,the benefits of a portable technology with a shorter time to result that can reach a larger population may come at the expense of lower specificity.Likewise,a more expensive test may be justified if it brings substantial added value in terms of improved performance and better suitability for decentralization,and if it reduces the need for confirmatory tests or other operational costs.For an infectious condition such as TB,with a large global burden of disease and death and a persistent shortfall in case detection,the potential impact of a new screening technology will depend heavily on operational factors that also influence a screening tests ability to fulfil its role(i.e.to identify more people who require further diagnostic work-up accurately and decrease their time to starting treatment).Although the TPPs indicate the attributes to be considered at the developmental stage of the test,these should not be dissociated from the factors to be considered at the implementation stage in the framework of overall TB-oriented activities within a programme,such as the optimal positioning of the test when scaling it up,the need to back it up with appropriate capacity to confirm or exclude a TB diagnosis,the provision of appropriate treatment for TB and comorbidities,and sustained infection control activities.195.ConclusionCurrent WHO recommendations on tools to use for TB screening are an important step for countries as they move towards the global targets for case-finding.However,by themselves,these recommendations will be insufficient to fully achieve the targets and bridge the gap in TB treatment coverage.Technologies that are intended for use at the level of the community or primary health care,and for which it is easy to collect biological samples,are likely to be critical going forward.WHO is issuing these TPPs to guide and encourage product development for new screening tools in these settings.The pursuit of improved approaches to TB screening fits into the global commitment to reduce the TB burden of disease and death.Providing access to effective screening to larger numbers of people at risk of TB requires clear communication of programmatic needs among stakeholders,particularly researchers,developers of technology and funders.Rapid identification of affected individuals needs to be matched with the timely provision of appropriate treatment.Although recent years have seen advances in the pipeline of tests for screening,important gaps remain.Hence,there is a need for improvements to existing technologies or the development of new technologies that can be used closer to the level of patient care,are priced affordably for low-and middle-income countries,and can provide accurate,rapid and comprehensive solutions for detecting TB.Addressing current challenges effectively and sustainably requires a multifaceted strategy that integrates technological innovation with considerations of scalability,affordability and adaptability to populations at risk.Ideally,future screening tests would satisfy all the optimal requirements set out in this document for the different test attributes.However,achieving such alignment across the different characteristics is unrealistic and trade-offs will be necessary;for example,prioritizing the characteristics that are likely to help in reaching universal health coverage,and delivering technologies that are reliable and practical to use.Collaboration among stakeholders,ongoing research and sustained innovation will be vital to overcome challenges on the path towards the realization of the ambitious targets set for TB.21References1.Global tuberculosis report 2024.Geneva:World Health Organization;2024(https:/iris.who.int/handle/10665/379339).Licence:CC BY-NC-SA 3.0 IGO.2.The End TB Strategy website.Geneva:World Health Organization;2014(https:/www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/the-end-tb-strategy).3.Meeting report:high-priority target product profiles for new tuberculosis diagnostics:report of a consensus meeting(WHO/HTM/TB/2014.18).Geneva:World Health Organization;2014(https:/apps.who.int/iris/bitstream/handle/10665/135617/WHO_HTM_TB_2014.18_eng.pdf).4.Uplekar M,Weil D,Lonnroth K,Jaramillo E,Lienhardt C,Dias HM et al.WHOs new End TB Strategy.Lancet.2015;385:1799801(https:/doi.org/10.1016/s0140-6736(15)60570-0).5.Comstock GW,Ferebee SH,Hammes LM.A controlled trial of community-wide isoniazid prophylaxis in Alaska.Am Rev Respir Dis.1967;95:93543(https:/pubmed.ncbi.nlm.nih.gov/6026165/).6.Comstock GW,Philip RN.Decline of the tuberculosis epidemic in Alaska.Public Health Rep.1961;76:1924(https:/pmc.ncbi.nlm.nih.gov/articles/PMC1929584/).7.Golub JE,Mohan CI,Comstock GW,Chaisson RE.Active case finding of tuberculosis:historical perspective and future prospects.Int J Tuberc Lung Dis.2005;9:1183203(https:/pubmed.ncbi.nlm.nih.gov/16333924/).8.Bogdanova E,Mariandyshev O,Hinderaker SG,Nikishova E,Kulizhskaya A,Sveshnikova O et al.Mass screening for active case finding of pulmonary tuberculosis in the Russian Federation:how to save costs.Int J Tuberc Lung Dis.2019;23:8307(https:/doi.org/10.5588/ijtld.18.0449).9.Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.Geneva:World Health Organization;2011(https:/apps.who.int/iris/bitstream/handle/10665/44472/9789241500708_eng.pdf).10.Recommendations for investigating contacts of persons with infectious tuberculosis in low-and middle-income countries.Geneva:World Health Organization;2012(https:/apps.who.int/iris/bitstream/handle/10665/77741/9789241504492_eng.pdf).11.Systematic screening for active tuberculosis:principles and recommendations(WHO/HTM/TB/2013.04).Geneva:World Health Organization;2013(http:/apps.who.int/iris/bitstream/10665/84971/1/9789241548601_eng.pdf).12.Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance:Xpert MTB/RIF system:policy statement.Geneva:World Health Organization;2011(https:/iris.who.int/handle/10665/44586).13.Law I,Floyd K.National tuberculosis prevalence surveys in Africa,20082016:an overview of results and lessons learned.Trop Med Int Health.2020;25:130827(https:/doi.org/10.1111/tmi.13485).14.Frascella B,Richards AS,Sossen B,Emery JC,Odone A,Law I et al.Subclinical tuberculosis disease a review and analysis of prevalence surveys to inform definitions,burden,associations,and screening methodology.Clin Infect Dis.2021;73:e830e41(https:/doi.org/10.1093/cid/ciaa1402).Target product profiles for tuberculosis screening tests2215.Report of the WHO consultation on asymptomatic tuberculosis,Geneva,Switzerland,1415 October 2024.Geneva:World Health Organization;2025(https:/iris.who.int/handle/10665/380616).16.Report of the WHO consultation on systematic screening for tuberculosis,Geneva,Switzerland,1618 October 2024.Geneva:World Health Organization;2025(in press).17.Portable digital radiography system:technical specifications.Geneva:World Health Organization;2021(https:/iris.who.int/handle/10665/344514).18.WHO consolidated guidelines on tuberculosis:module 2:screening:systematic screening for tuberculosis disease.Geneva:World Health Organization;2021(https:/iris.who.int/handle/10665/340255).19.WHO operational handbook on tuberculosis:module 2:screening:systematic screening for tuberculosis disease.Geneva:World Health Organization;2021(https:/iris.who.int/handle/10665/340256).20.Marks GB,Nguyen NV,Nguyen PTB,Nguyen TA,Nguyen HB,Tran KH et al.Community-wide screening for tuberculosis in a high-prevalence setting.N Engl J Med.2019;381:134757(https:/doi.org/10.1056/NEJMoa1902129).21.Resolution 78/5:Political declaration of the second high-level meeting of the General Assembly on the fight against tuberculosis.New York:United Nations General Assembly;2023(https:/digitallibrary.un.org/record/4025280).22.Target product profiles for tuberculosis diagnosis and detection of drug resistance.Geneva:World Health Organization;2024(https:/iris.who.int/handle/10665/378358).23.WHO consolidated guidelines on tuberculosis:module 3:diagnosis:rapid diagnostics for tuberculosis detection,2021 update.Geneva:World Health Organization;2021(https:/iris.who.int/handle/10665/342331).24.National tuberculosis prevalence surveys 20072016.Geneva:World Health Organization;2021(https:/iris.who.int/handle/10665/341072).25.Aung ST,Nyunt WW,Moe MM,Aung HL,Lwin T.The fourth national tuberculosis prevalence survey in Myanmar.PLoS Glob Public Health.2022;2:e0000588(https:/doi.org/10.1371/journal.pgph.0000588).26.Moyo S,Ismail F,Van der Walt M,Ismail N,Mkhondo N,Dlamini S et al.Prevalence of bacteriologically confirmed pulmonary tuberculosis in South Africa,201719:a multistage,cluster-based,cross-sectional survey.Lancet Infect Dis.2022;22:117280(https:/doi.org/10.1016/s1473-3099(22)00149-9).27.Matji R,Maama L,Roscigno G,Lerotholi M,Agonafir M,Sekibira R et al.Policy and programmatic directions for the Lesotho tuberculosis programme:findings of the national tuberculosis prevalence survey,2019.PLoS One.2023;18:e0273245(https:/doi.org/10.1371/journal.pone.0273245).28.Regulation(EU)2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data,and repealing Directive 95/46/EC(General Data Protection Regulation).Luxemborg:Official Journal of the European Union;2016(https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32016R0679).29.IEC 62304:2006:Medical device software software life cycle processes(edition 1).Geneva:International Organization for Standardization/International Electrotechnical Commission;2006(https:/www.iso.org/standard/38421.html).30.ISO 13485:2016:Medical devices quality management systems requirements for regulatory purposes.Geneva:International Organization for Standardization;2016(https:/www.iso.org/obp/ui/en/#iso:std:iso:13485:ed-3:v1:en).31.ISO 14971:2019:Medical devices application of risk management to medical devices(edition 3).Geneva:International Organization for Standardization;2019(https:/www.iso.org/standard/72704.html).23Annex 1.Overview of the results of the Delphi-like consultation and WHO public comment process for the TPP for TB screening testsTo develop the updated World Health Organization(WHO)target product profiles(TPPs)for novel screening tests for tuberculosis(TB),a Delphi-like consultation was conducted with the Scientific TPP Development Group,to facilitate consensus-building around the core components of the updated TPP.Following the consultation,a public commentary process was held to seek input from a broad range of constituents;a total of 276 individuals expressed interest in this process,and 163(59%)individuals consented to participate and provided input.During the Delphi-like consultation with the Scientific TPP Development Group,overall,there was a high level of consensus on many key aspects of the TPP.Through subsequent discussions and incorporating feedback from the public commentary,consensus was achieved on all parameters.This annex summarizes the survey results,key discussions and inputs from public commentary on all aspects of the TPP.ScopeOverall,there was a high level of agreement for the parameters included in the“Scope”section.There was complete agreement on the goal of a screening test;a public comment suggested separating out symptomatic and asymptomatic populations for minimal and optimal tests but the expert group agreed this was not ideal,given the desire for the next generation of screening tests to be able to detect asymptomatic TB across all settings.There was 98%and 91%agreement from the expert group on the target populations for novel screening tests in the minimal and optimal cases,respectively.Some members of the group felt that targeting populations down to 0.25%TB prevalence for screening was unrealistic given the high costs involved,but ultimately the group felt that it was important to keep this level of ambition in the updated TPP document.There were suggestions to include mention of pregnant women and paediatric populations of different age ranges wherever possible.There was 93%and 86%agreement on the target user of novel screening tests in the minimal and optimal cases,respectively,with the expert group encouraging the inclusion of a self-testing modality in the TPP.There was 93%agreement on the target setting of the test,with the expert group agreeing that,ideally,novel screening tests should be able to be conducted in a variety of settings and not limited to health care facilities,even in a minimal case.Target product profiles for tuberculosis screening tests24PerformanceAlthough there was a diversity of thinking with regard to test performance,overall,there was high agreement(80%)on all the specific accuracy values(sensitivity and specificity)for all types of screening tests included in the document,with two exceptions.The first exception was the minimum specificity of a high-sensitivity test in a two-step algorithm;originally,this was set at 50%,and this value had 72%agreement.However,the expert group felt that the value of 50%was too low and would result in extraneous costs for screening implementation;thus,it was amended to 60%.The second exception was the minimum sensitivity of a high-specificity test;originally,this was set at 50%,and this value had 68%agreement.However,the expert group again felt that the value of 50%was too low and would result in unacceptable case detection for screening programmes;thus,it was amended to 60%.Throughout the discussions,it was noted that the target accuracy values need to be combined with other characteristics(e.g.the setting of the test,time to result and ease of use),to ensure that such a novel test would be useful in programmatic screening implementation.PricingInitially,there was less agreement in the area of pricing,with agreement levels of 56%and 66%,respectively,for proposed minimal and optimal per-test costs.Many group members felt the proposed unit costs were too high,given the volume of testing required in large-scale screening.There was extensive discussion during the expert consultation,which resulted in updated unit costs for all three types of screening tests described in the document.Although the group acknowledged the importance of market value in screening tests,it also felt strongly that it is necessary to advocate for cheaper screening tests,especially for a benchmark of a US$1 per test in the optimal case.The group also felt that having a separate price point for capital costs for a screening test was unnecessary;rather,members preferred to include all aspects of pricing under a unit cost.Operational characteristicsThere was generally high agreement across operational characteristic parameters.On the specimen type,agreement was 88%and 84%,respectively,for the minimal and optimal cases,with some discussion to ensure that the document included a broad array of potential sample types that would be easy to obtain.There was 70%and 86%agreement for the minimal and optimal time to result,respectively,with the group largely agreeing on the optimal time frame for a screening test.Subsequent discussion focused on the acceptable time to result for the minimal case.There was 86%agreement on the minimal requirements for the instrument type for novel screening tests,but a slightly lower agreement level of 79%for the optimal case,as members of the Scientific Expert Group discussed how to capture a wide range of possible new test technologies within the document.The following characteristics all had over 80%agreement from the expert group in the Delphi-like consultation:preparation of 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