Asma Binte Aziz,Susanne Dudman,Khalequ Zaman,John D Clemens
{"title":"Hepatitis E vaccine and fetal loss: the potential pathophysiological basis - Authors' reply.","authors":"Asma Binte Aziz,Susanne Dudman,Khalequ Zaman,John D Clemens","doi":"10.1016/s2214-109x(24)00412-1","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00412-1","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"234 1","pages":"e1760"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robin C Nesbitt,Andrew S Azman,Vincent Kinya Asilaza,Jessie K Edwards,Priscillah Gitahi,Patrick Nkemenang,Jetske Duncker,Melat Haile,Primitive Gakima,Joseph F Wamala,Fredrick Beden Loro,Duol Biem,Nelly Staderini,Manuel Albela,Monica Rull,John Rumunu,Iza Ciglenecki,Etienne Gignoux
{"title":"Safety of hepatitis E vaccine in pregnancy: an emulated target trial following a mass reactive vaccination campaign in Bentiu internally displaced persons camp, South Sudan.","authors":"Robin C Nesbitt,Andrew S Azman,Vincent Kinya Asilaza,Jessie K Edwards,Priscillah Gitahi,Patrick Nkemenang,Jetske Duncker,Melat Haile,Primitive Gakima,Joseph F Wamala,Fredrick Beden Loro,Duol Biem,Nelly Staderini,Manuel Albela,Monica Rull,John Rumunu,Iza Ciglenecki,Etienne Gignoux","doi":"10.1016/s2214-109x(24)00321-8","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00321-8","url":null,"abstract":"BACKGROUNDEpidemic forms of hepatitis E cause high mortality among pregnant people, with case fatality risks over 30% and adverse fetal outcomes. In 2022, the first mass reactive vaccination campaign against hepatitis E was conducted in South Sudan with the HEV239 vaccine. We aimed to assess whether vaccination against hepatitis E in pregnancy increases the risk of fetal loss in a cohort of vaccinated and unvaccinated pregnant people.METHODSIn this emulated target trial, an exhaustive pregnancy census was conducted in Bentiu internally displaced persons camp after the second of three vaccination rounds. Women and girls aged 14-45 years with no current jaundice or acute illness were eligible for participation. Individuals who consented were revisited 28 days after their delivery date to document the pregnancy outcome. We used an emulated target trial framework to address biases inherent in observational studies. We matched vaccinated to unvaccinated participants on age, gestational age, and vaccination propensity score and estimated cumulative incidence functions for fetal loss in vaccinated compared to unvaccinated women in a competing risks framework using the Aalen-Johansen estimator.FINDINGSBetween May 16 and June 30, 2022, 3421 participants were enrolled and followed up for inclusion in analysis. Among 2741 women who had a pregnancy outcome after the start of the vaccination campaign, 67 (2·4%) were vaccinated before conception, 2036 (74·3%) were vaccinated during pregnancy, and 638 (23·2%) were not vaccinated. Among the 2407 women retained in the matched analyses, the cumulative risk of fetal loss among individuals vaccinated during pregnancy was 7·2% (95% CI 5·6-8·7) compared with 6·1% (3·7-9·2) among unvaccinated individuals, implying a risk ratio of 1·2 (95% CI 0·7-1·9).INTERPRETATIONNo evidence of increased risk of fetal loss was found among individuals vaccinated during pregnancy.FUNDINGMédecins Sans Frontières.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"233 1","pages":"e1881-e1890"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Agnes Natukunda,Gyaviira Nkurunungi,Ludoviko Zirimenya,Jacent Nassuuna,Christopher Zziwa,Caroline Ninsiima,Josephine Tumusiime,Ruth Nyanzi,Milly Namutebi,Fred Kiwudhu,Govert J van Dam,Paul L A M Corstjens,Robert Kizindo,Ronald Nkangi,Joyce Kabagenyi,Beatrice Nassanga,Stephen Cose,Anne Wajja,Pontiano Kaleebu,Alison M Elliott,Emily L Webb,
{"title":"Schistosome and malaria exposure and urban-rural differences in vaccine responses in Uganda: a causal mediation analysis using data from three linked randomised controlled trials.","authors":"Agnes Natukunda,Gyaviira Nkurunungi,Ludoviko Zirimenya,Jacent Nassuuna,Christopher Zziwa,Caroline Ninsiima,Josephine Tumusiime,Ruth Nyanzi,Milly Namutebi,Fred Kiwudhu,Govert J van Dam,Paul L A M Corstjens,Robert Kizindo,Ronald Nkangi,Joyce Kabagenyi,Beatrice Nassanga,Stephen Cose,Anne Wajja,Pontiano Kaleebu,Alison M Elliott,Emily L Webb,","doi":"10.1016/s2214-109x(24)00340-1","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00340-1","url":null,"abstract":"BACKGROUNDVaccine immunogenicity and effectiveness vary geographically. Chronic immunomodulating parasitic infections including schistosomes and malaria have been hypothesised to be mediators of geographical variations.METHODSWe compared vaccine-specific immune responses between three Ugandan settings (schistosome-endemic rural, malaria-endemic rural, and urban) and did causal mediation analysis to assess the role of Schistosoma mansoni and malaria exposure in observed differences. We used data from the control groups of three linked randomised trials investigating the effects of intensive parasite treatment among schoolchildren. All participants received the BCG vaccine (week 0); yellow fever (YF-17D), oral typhoid (Ty21a), human papillomavirus (HPV; week 4); and HPV booster and tetanus-diphtheria (week 28). Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, week 52. We estimated the total effect (TE) of setting on vaccine responses and natural indirect effect (NIE) mediated through current or previous infection with S mansoni or malaria, and baseline vaccine-specific responses.FINDINGSWe included 239 (43%) participants from the schistosomiasis-endemic setting, 171 (30%) from the malaria-endemic setting, and 151 (27%) from the urban setting. At week 8, vaccine responses were lower in rural settings: schistosomiasis-endemic versus urban settings (TE geometric mean ratio for YF-17D plaque reduction neutralisation at 50% (PRNT50) titres 0·58 [95% CI 0·37 to 0·91], for S Typhi O-lipopolysaccharide-specific IgG 0·61 [0·40 to 0·93], and for tetanus-specific IgG 0·33 [0·22 to 0·51]); malaria-endemic versus urban settings (YF-17D 0·70 [0·49 to 0·99], S Typhi O-lipopolysaccharide-specific IgG 0·29 [0·20 to 0·43], and tetanus-specific IgG 0·53 [-0·35 to 0·80]). However, we found higher BCG-specific IFNγ responses in the malaria-endemic versus urban setting (1·54 [1·20 to 1·98]). The estimated NIEs of setting on vaccine responses mediated through previous and current S mansoni and malaria were not statistically significant. For malaria-endemic versus urban settings, baseline vaccine-specific responses contributed to some but not all differences: S Typhi O-lipopolysaccharide-specific IgG at week 8 (57.9% mediated [38·6 to 77·2]) and week 52 (70·0% mediated [49·4 to 90·6]) and BCG at week 52 (46.4% mediated [-4·8 to 97·7]).INTERPRETATIONWe found significant variation in vaccine response between urban and rural settings but could not confirm a causal role for schistosome or malaria exposure. Other exposures require consideration.FUNDINGUK Medical Research Council.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"23 1","pages":"e1860-e1870"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rapid surveys on violence against women in crisis contexts: decision-making guidance based on the UN Women Rapid Gender Assessment surveys on violence against women during COVID-19.","authors":"Raphaëlle Rafin,Nabamallika Dehingia,Juncal Plazaola-Castaño,Anita Raj","doi":"10.1016/s2214-109x(24)00278-x","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00278-x","url":null,"abstract":"Rapid surveys or assessments offer the possibility to collect data in contexts where classic data collection is not feasible (such as health, humanitarian, or climate crises) and when evidence-based urgent action is needed to mitigate the effects of the crisis. Until the past 5 years, rapid surveys were not widely used by practitioners, researchers, or policy makers to measure the effect of crises on violence against women due to a paucity of empirical evidence on their safety and likely utility in such contexts. In recent years, and particularly during the COVID-19 global pandemic, UN Women led the piloting and implementation of such surveys in various countries. We use our experiences from this work and other studies to offer concrete decision-making guidance-in the form of a checklist-for whether to conduct rapid surveys on violence against women in crisis contexts, with consideration of their value, risks, and the minimum safeguards needed to implement this type of work.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"12 1","pages":"e1899-e1904"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fixing the system to end violence against women.","authors":"The Lancet Global Health","doi":"10.1016/s2214-109x(24)00429-7","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00429-7","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"124 1","pages":"e1737"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ursula Gazeley,Antonino Polizzi,Julio Romero Prieto,José Manuel Aburto,Georges Reniers,Veronique Filippi
{"title":"The lifetime risk of maternal near miss morbidity in Asia, Africa, the Middle East, and Latin America: a cross-country systematic analysis.","authors":"Ursula Gazeley,Antonino Polizzi,Julio Romero Prieto,José Manuel Aburto,Georges Reniers,Veronique Filippi","doi":"10.1016/s2214-109x(24)00322-x","DOIUrl":"https://doi.org/10.1016/s2214-109x(24)00322-x","url":null,"abstract":"BACKGROUNDLife-threatening maternal near miss (MNM) morbidity can have long-term consequences for the physical, psychological, sexual, social, and economic wellbeing of female individuals. The lifetime risk of MNM (LTR-MNM) quantifies the probability that a female individual aged 15 years will have an MNM before age 50 years, given current mortality and fertility rates. We compare the LTR-MNM globally to reveal inequities in the cumulative burden of severe maternal morbidity across the reproductive life course.METHODSWe estimated the LTR-MNM for 40 countries with multifacility, regional, or national data on the prevalence of MNM morbidity measured using WHO or modified WHO criteria of organ dysfunction from 2010 onwards (Central and Southern Asia=6, Eastern and Southeastern Asia=9, Latin America and the Caribbean=10, Northern Africa and Western Asia=2, sub-Saharan Africa=13). We also calculated the lifetime risk of severe maternal outcome (LTR-SMO) as the lifetime risk of maternal death or MNM.FINDINGSThe LTR-MNM ranges from a 1 in 269 risk in Viet Nam (2010) to 1 in 6 in Guatemala (2016), whereas the LTR-SMO ranges from a 1 in 201 risk in Malaysia (2014) to 1 in 5 in Guatemala (2016). The LTR-MNM is a 1 in 20 risk or higher in nine countries, seven of which are in sub-Saharan Africa. The LTR-SMO is a 1 in 20 risk or higher in 11 countries, eight of which are in sub-Saharan Africa. The relative contribution of the LTR-MNM to the LTR-SMO ranges from 42% in Angola to 99% in Japan.INTERPRETATIONThere exist substantial global and regional disparities in the cumulative burden of severe maternal morbidity across the reproductive life course. The LTR-MNM is an important indicator to highlight the magnitude of inequalities in MNM morbidity, once accounting for obstetric risk, fertility rates, and mortality rates. The LTR-SMO can be used to highlight variation in the relative importance of morbidity to the overall burden of maternal ill-health across the female reproductive life course, given countries' stage in the obstetric transition. Both the LTR-MNM and LTR-SMO can serve as important indicators to advocate for further global commitment to end preventable maternal morbidity and mortality.FUNDINGUK Economic and Social Research Council, EU Horizon 2020 Marie Curie Fellowship, and Leverhulme Trust Large Centre Grant.","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"83 1","pages":"e1775-e1784"},"PeriodicalIF":34.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet Global HealthPub Date : 2024-11-01Epub Date: 2024-09-05DOI: 10.1016/S2214-109X(24)00318-8
{"title":"Mechanisms and causes of death after abdominal surgery in low-income and middle-income countries: a secondary analysis of the FALCON trial.","authors":"","doi":"10.1016/S2214-109X(24)00318-8","DOIUrl":"10.1016/S2214-109X(24)00318-8","url":null,"abstract":"<p><strong>Background: </strong>Death after surgery is devasting for patients, families, and communities, but remains common in low-income and middle-income countries (LMICs). We aimed to use high-quality data from an existing global randomised trial to describe the causes and mechanisms of postoperative mortality in LMICs. To do so, we developed a novel framework, learning from both existing classification systems and emerging insights during data analysis.</p><p><strong>Methods: </strong>This study was a preplanned secondary analysis of the FALCON trial in 54 hospitals across seven LMICs (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). FALCON was a pragmatic, 2 × 2 factorial, randomised controlled trial that compared the effectiveness of two types of interventions for skin preparation (10% aqueous povidone-iodine vs 2% alcoholic chlorhexidine) and sutures (triclosan-coated vs uncoated). Patients who did not have surgery or were lost to follow-up were excluded (n=231). The primary outcomes of the present analysis were the mechanism and cause of death within 30-days of surgery, determined using a modified verbal autopsy strategy from serious adverse event reports. Factors associated with mortality were explored in a mixed-effects Cox proportional hazards model. The FALCON trial is registered with ClinicalTrials.gov, NCT03700749.</p><p><strong>Findings: </strong>This preplanned secondary analysis of the FALCON trial included 5558 patients who underwent abdominal surgery, of whom 4248 (76·4%) patients underwent surgery in tertiary, referral centres and 1310 (23·6%) underwent surgery in primary referral (ie, district or rural) hospitals. 3704 (66·7%) of 5558 surgeries were emergent. 306 (5·5%) of 5558 patients died within 30 days of surgery. 226 (74%) of 306 deaths were due to circulatory system failure, which included 173 (57%) deaths from sepsis and 29 (9%) deaths from hypovolaemic shock including bleeding. 47 (15%) deaths were due to respiratory failure. 60 (20%) of 306 patients died without a clear cause of death: 45 (15%) patients died with sepsis of unknown origin and 15 (5%) patients died of an unknown cause. 46 (15%) of 306 patients died within 24 h, 111 (36%) between 24 h and 72 h, 57 (19%) between >72 h and 168 h, and 92 (30%) more than 1 week after surgery. 248 (81%) of 306 patients died in hospital and 58 (19%) patients died out of hospital. The adjusted Cox regression model identified age (hazard ratio 1·01, 95% CI 1·01-1·02; p<0·0001), ASA grade III-V (4·93, 3·45-7·03; p<0·0001), presence of diabetes (1·47, 1·04-2·41; p=0·033), being an ex-smoker (1·59, 1·10-2·30; p=0·013), emergency surgery (2·08, 1·45-2·98; p<0·0001), cancer (1·98, 1·42-2·76; p<0·0001), and major surgery (3·94, 2·30-6·75; p<0·0001) as risk factors for postoperative mortality INTERPRETATION: Circulatory failure leads to most deaths after abdominal surgery, with sepsis accounting for almost two-thirds. Variability in timing of death highlights opportun","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":"e1807-e1815"},"PeriodicalIF":19.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142156357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Omar Syarif, Rita Oladele, Tinne Gils, Radha Rajasingham, Jonathan Falconer, Pamela Achii, Edna Tembo, Donald Denis Tobaiwa, Kenneth Mwehonge, Charlotte Schutz, Nelesh P Govender, Graeme Meintjes, David B Meya, Angela Loyse
{"title":"Resolving the CD4-testing crisis to help end AIDS-related deaths.","authors":"Omar Syarif, Rita Oladele, Tinne Gils, Radha Rajasingham, Jonathan Falconer, Pamela Achii, Edna Tembo, Donald Denis Tobaiwa, Kenneth Mwehonge, Charlotte Schutz, Nelesh P Govender, Graeme Meintjes, David B Meya, Angela Loyse","doi":"10.1016/S2214-109X(24)00444-3","DOIUrl":"https://doi.org/10.1016/S2214-109X(24)00444-3","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nicaise Ndembi, Ngashi Ngongo, Moréniké Oluwátóyìn Foláyan, Jean Marie Yameogo, Fiona Braka, Salam Abdou Gueye, Moeti Matshidiso, Jean Kaseya
{"title":"Africa's mpox strategic preparedness and response plan: a coordinated continental effort to boost health security.","authors":"Nicaise Ndembi, Ngashi Ngongo, Moréniké Oluwátóyìn Foláyan, Jean Marie Yameogo, Fiona Braka, Salam Abdou Gueye, Moeti Matshidiso, Jean Kaseya","doi":"10.1016/S2214-109X(24)00464-9","DOIUrl":"https://doi.org/10.1016/S2214-109X(24)00464-9","url":null,"abstract":"","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carina King, Rochelle Ann Burgess, Ayobami A Bakare, Funmilayo Shittu, Julius Salako, Damola Bakare, Obioma C Uchendu, Agnese Iuliano, Nehla Djellouli, Adamu Isah, Ibrahim Haruna, Samy Ahmar, Tahlil Ahmed, Paula Valentine, Temitayo Folorunso Olowookere, Matthew MacCalla, Hamish R Graham, Eric D McCollum, James Beard, Adegoke G Falade, Tim Colbourn
{"title":"Effect of a participatory whole-systems approach on mortality in children younger than 5 years in Jigawa state, Nigeria (INSPIRING trial): a community-based, parallel-arm, pragmatic, cluster randomised controlled trial and concurrent mixed-methods process evaluation.","authors":"Carina King, Rochelle Ann Burgess, Ayobami A Bakare, Funmilayo Shittu, Julius Salako, Damola Bakare, Obioma C Uchendu, Agnese Iuliano, Nehla Djellouli, Adamu Isah, Ibrahim Haruna, Samy Ahmar, Tahlil Ahmed, Paula Valentine, Temitayo Folorunso Olowookere, Matthew MacCalla, Hamish R Graham, Eric D McCollum, James Beard, Adegoke G Falade, Tim Colbourn","doi":"10.1016/S2214-109X(24)00369-3","DOIUrl":"https://doi.org/10.1016/S2214-109X(24)00369-3","url":null,"abstract":"<p><strong>Background: </strong>In 2019, Nigeria reported the highest mortality rate in children younger than 5 years globally. We aimed to assess a whole-systems approach to improving child mortality in northern Nigeria.</p><p><strong>Methods: </strong>We conducted a community-based, parallel-arm, pragmatic, cluster randomised controlled trial in Kiyawa local government area, Jigawa state, Nigeria, and a concurrent mixed-methods process evaluation using ethnography and quantitative implementation monitoring. Trial clusters were population catchment areas of 32 government primary health-care facilities. Compounds were randomly sampled, proportional to cluster size, and all women aged 16-49 years and children younger than 5 years who were permanent residents were eligible for inclusion and recruited as the evaluation population. Children younger than 7 days were recruited but excluded from analysis. Evaluation clusters were allocated to intervention or control via simple randomisation with a 1:1 ratio. Cluster names were written on paper, folded, and placed in a container by community representatives. Different community representatives took out names one by one, with the first half assigned to receive the intervention. The intervention consisted of three components: participatory learning and action (PLA) groups for men and women (including compound heads [ie, the member of the compound that residents deemed most senior]), partnership defined quality scorecard (PDQS), and health-care worker capacity building; it was delivered from March 1, 2021, to Dec 31, 2022. We could not mask participants, field staff, or intervention-delivery staff to cluster allocation but baseline, endline, and follow-up data excluded information on cluster allocation. PLA groups involved separate groups of up to 25 men or women from all villages in the intervention clusters. The primary outcome was all-cause mortality in children aged 7 days to 59 months between Oct 1, 2021, and Sept 20, 2022, referred to as the evaluation period. The trial was prospectively registered (ISRCTN 39213655) and the protocol has been published.</p><p><strong>Findings: </strong>We recruited 3800 compounds at baseline, with 12 893 children contributing to analysis of the primary outcome (7316 [56·8%] of 12 893 in the intervention group and 5577 [43·3%] in the control group). 6617 (51·3%) of 12 893 children were male, 6275 (48·7%) were female, and one (<0·1%) child had missing sex data. Sampled compounds randomly came from 388 (91·3%) of 425 villages in the 32 clusters. We conducted verbal autopsies for 1182 deaths, of which 369 (31·2%) were children aged 7 days to 59 months during the evaluation period. Of these 369, 91 (24·7%) were classified as pneumonia deaths. Children contributed a median 361 days (IQR 236-365) to the analysis, with 369 (2·9%) of 12 893 children censored on their date of death, 1545 (12·0%) on their 5th birthday, and 3392 (26·3%) on the date of the most recent follow-up in ","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":" ","pages":""},"PeriodicalIF":19.9,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}