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Background Antibiotic use during early infancy has been linked to childhood obesity in high-income countries. We evaluated whether a single oral dose of azithromycin administered during infant-well visits led to changes in infant growth outcomes at 6 months of age in a setting with a high prevalence of undernutrition in rural Burkina Faso. Methods and findings Infants were enrolled from September 25, 2019, until October 22, 2022, in a randomized controlled trial designed to evaluate the efficacy of a single oral dose of azithromycin (20 mg/kg) compared to placebo when administered during well-child visits for prevention of infant mortality. The trial found no evidence of a difference in the primary endpoint. This paper presents prespecified secondary anthropometric endpoints including weight gain (g/day), height change (mm/day), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and mid-upper arm circumference (MUAC). Infants were eligible for the trial if they were between 5 and 12 weeks of age, able to orally feed, and their families were planning to remain in the study area for the duration of the study. Anthropometric measurements were collected at enrollment (5 to 12 weeks of age) and 6 months of age. Among 32,877 infants enrolled in the trial, 27,298 (83%) were followed and had valid anthropometric measurements at 6 months of age. We found no evidence of a difference in weight gain (mean difference 0.03 g/day, 95% confidence interval (CI) -0.12 to 0.18), height change (mean difference 0.004 mm/day, 95% CI -0.05 to 0.06), WAZ (mean difference -0.004 SD, 95% CI -0.03 to 0.02), WLZ (mean difference 0.001 SD, 95% CI -0.03 to 0.03), LAZ (mean difference -0.005 SD, 95% CI -0.03 to 0.02), or MUAC (mean difference 0.01 cm, 95% CI -0.01 to 0.04). The primary limitation of the trial was that measurements were only collected at enrollment and 6 months of age, precluding assessment of shorter-term or long-term changes in growth. Conclusions Single-dose azithromycin does not appear to affect weight and height outcomes when administered during early infancy. Trial registration ClinicalTrials.gov NCT03676764, Author(s): Ali Sié 1,2,*, Mamadou Ouattara 1, Mamadou Bountogo 1, Clarisse Dah 1, Thierry Ouedraogo 1, Valentin Boudo 1, Elodie Lebas 2, Huiyu Hu 2, Benjamin F. Arnold 2,3,4, Kieran [...]

Monitoring trachoma transmission with antibody data requires characterization of decay in IgG to Chlamydia trachomatis antigens. In a 3-year longitudinal cohort in a high-transmission setting, we estimated a median IgG half-life of 3 years and a seroreversion rate of 2.5 per 100 person-years (95% confidence interval, 1.6–3.5). Clinical Trials Registration NCT02754583. [ABSTRACT FROM AUTHOR]

Objective To determine whether a water, sanitation and hygiene intervention could change hygiene behaviours thought to be important for trachoma control. Methods We conducted a cluster-randomized trial in rural Ethiopia from 9 November 2015 to 5 March 2019. We randomized 20 clusters to an intervention consisting of water and sanitation infrastructure and hygiene promotion and 20 clusters to no intervention. All intervention clusters received a primary-school hygiene curriculum, community water point, household wash station, household soap and home visits from hygiene promotion workers. We assessed intervention fidelity through annual household surveys. Findings Over the 3 years, more wash stations, soap and latrines were seen at households in the intervention clusters than the control clusters: risk difference 47 percentage points (95% confidence interval, CI: 41- 53) for wash stations, 18 percentage points (95% CI: 12-24) for soap and 12 percentage points (95% CI: 5-19) for latrines. A greater proportion of people in intervention clusters reported washing their faces with soap (e.g. risk difference 21 percentage points; 95% CI: 15-27 for 0- 5 year-old children) and using a latrine (e.g. risk difference 9 percentage points; 95% CI: 2-15 for 6-9 year-old children). Differences between the intervention and control arms were not statistically significant for many indicators until the programme had been implemented for at least a year; they did not decline during later study visits. Conclusion The community- and school-based intervention was associated with improved hygiene access and behaviours, although changes in behaviour were slow and required several years of the intervention. Objectif Determiner si une intervention au niveau de l'eau, de l'assainissement et de 1'hygiene pourrait avoir une influence sur les comportements en la matiere, consideres comme importants dans la lutte contre le trachome. Methodes Nous avons mene un essai randomise par grappes dans les regions rurales d'Ethiopie entre le 9 novembre 2015 et le 5 mars 2019. Nous avons reparti aleatoirement 20 echantillons ou l'intervention consistait a developper les infrastructures d'assainissement et d'approvisionnement en eau et a promouvoir l'hygiene, et 20 echantillons n'ayant fait l'objet d'aucune intervention. Tous les echantillons du groupe d'intervention ont suivi une formation sur l'hygiene a l'ecole primaire, disposaient d'un point d'eau communautaire, d'un poste de lavage par menage, de savon a domicile, et recevaient des visites de la part de travailleurs charges d'enseigner les bonnes pratiques en matiere d'hygiene. Nous avons evalue le niveau d'observance des mesures en effectuant des enquetes annuelles au sein des foyers. Resultats En l'espace de 3 ans, le nombre de postes de lavage, de savons et de latrines dans les menages a davantage augmente dans le groupe d'intervention que dans le groupe de controle: la difference de risque s'elevait a 47 points de pourcentage (intervalle de confiance de 95%, IC: 41-53) pour les postes de lavage, a 18 points de pourcentage (IC de 95%: 12-24) pour le savon et a 12 points de pourcentage (IC de 95%: 5-19) pour les latrines. La proportion de gens declarant se laver le visage au savon etait plus grande dans le groupe d'intervention (difference de risque de 21 points de pourcentage; IC de 95%: 15-27 pour les enfants de 0 a 5 ans), tout comme celle mentionnant l'usage de latrines (difference de risque de 9 points de pourcentage; IC de 95%: 2-15 pour les enfants de 6 a 9 ans). Pour de multiples indicateurs, il a fallu attendre minimum un an apres l'instauration du programme pour que les variations observees entre les groupes d'intervention et de controle deviennent statistiquement significatives; ces variations se sont ensuite maintenues lors des visites ulterieures. Conclusion Intervenir a l'ecole et au sein de la communaute a permis d'ameliorer l'acces a l'hygiene et les comportements en la matiere. Neanmoins, cette evolution prend du temps et plusieurs annees d'intervention sont necessaires. Objetivo Determinar si una intervencion de agua, saneamiento e higiene cambiaria las practicas de higiene que se consideran importantes para el control del tracoma. Metodos Se realizo un ensayo aleatorizado por grupos en zonas rurales de Etiopia del 9 de noviembre de 2015 al 5 de marzo de 2019. Se asignaron de manera aleatoria 20 grupos a una intervencion que consistia en infraestructura de agua y saneamiento y promocion de la higiene, y 20 grupos a ninguna intervencion. Todos los grupos de intervencion recibieron un programa educativo sobre higiene en la escuela primaria, un punto de abastecimiento de agua en la comunidad, una estacion de lavado en el hogar, jabon en el hogar y visitas a domicilio de profesionales dedicados a la promocion de la higiene. Se evaluo la fidelidad de la intervencion mediante encuestas anuales en los hogares. Resultados Durante los tres anos, se observaron mas estaciones de lavado, jabon y letrinas en los hogares de los grupos de intervencion que en los de control: diferencia de riesgo de 47 puntos porcentuales (intervalo de confianza del 95 %, IC: entre 41 y 53) para las estaciones de lavado, 18 puntos porcentuales (IC del 95 %: entre 12 y 24) para el jabon y 12 puntos porcentuales (IC del 95 %: entre 5 y 19) para las letrinas. Un mayor porcentaje de personas en los grupos de intervencion informo de que se lavaba la cara con jabon (p. ej., diferencia de riesgo de 21 puntos porcentuales; IC del 95 %: entre 15 y 27; para ninos de 0 a 5 anos) y de que usaba una letrina (p. ej., diferencia de riesgo de 9 puntos porcentuales; IC del 95 %: entre 2 y 15; para ninos de 6 a 9 anos). Las diferencias entre los grupos de intervencion y de control no fueron significativas desde el punto de vista estadistico para muchos indicadores hasta que el programa se ejecuto durante al menos un ano; tampoco disminuyeron durante las visitas posteriores del estudio. Conclusion La intervencion en la comunidad y en la escuela se asocio a una mejora del acceso y de las practicas de higiene, aunque los cambios en las practicas fueron lentos y necesitaron varios anos de intervencion., Introduction The World Health Organization recommends improvements in water sources and promotion of facial cleanliness for trachoma elimination. (1) However, very few randomized trials have assessed whether hygiene interventions targeted [...]

BACKGROUND: Diarrheal disease is a leading cause of childhood morbidity and mortality globally. Household water, sanitation, and handwashing (WASH) interventions can reduce exposure to diarrhea-causing pathogens, but meteorological factors may impact their effectiveness. Information about effect heterogeneity under different weather conditions is critical to refining these targeted interventions. OBJECTIVES: We aimed to determine whether temperature and precipitation modified the effect of low-cost, point-of-use WASH interventions on child diarrhea. METHODS: We analyzed data from a trial in rural Bangladesh that compared child diarrhea prevalence between clusters (푁 = 720) that were randomized to different WASH interventions between 2012 and 2016 (NCT01590095). We matched temperature and precipitation measurements to diarrhea outcomes (푁 = 12,440 measurements, 6,921 children) by geographic coordinates and date. We estimated prevalence ratios (PRs) using generative additive models and targeted maximum likelihood estimation to assess the effectiveness of each WASH intervention under different weather conditions. RESULTS: Generally, WASH interventions most effectively prevented diarrhea during monsoon season, particularly following weeks with heavy rain or high temperatures. The PR for diarrhea in the WASH interventions group compared with the control group was 0.49 (95% CI: 0.35, 0.68) after 1 d of heavy rainfall, with a less-protective effect [PR = 0:87 (95% CI: 0.60, 1.25)] when there were no days with heavy rainfall. Similarly, the PR for diarrhea in the WASH intervention group compared with the control group was 0.60 (95% CI: 0.48, 0.75) following above-median temperatures vs. 0.91 (95% CI: 0.61, 1.35) following below-median temperatures. The influence of precipitation and temperature varied by intervention type; for precipitation, the largest differences in effectiveness were for the sanitation and combined WASH interventions. DISCUSSION: WASH intervention effectiveness was strongly influenced by precipitation and temperature, and nearly all protective effects were observed during the rainy season. Future implementation of these interventions should consider local environmental conditions to maximize effectiveness, including targeted efforts to maintain latrines and promote community adoption ahead of monsoon seasons. [ABSTRACT FROM AUTHOR]

Background Diarrhea and acute respiratory infection (ARI) are leading causes of death in children. The WASH Benefits Bangladesh trial implemented a multicomponent sanitation intervention that led to a 39% reduction in the prevalence of diarrhea among children and a 25% reduction for ARI, measured 1 to 2 years after intervention implementation. We measured longer-term intervention effects on these outcomes between 1 to 3.5 years after intervention implementation, including periods with differing intensity of behavioral promotion. Methods and findings WASH Benefits Bangladesh was a cluster-randomized controlled trial of water, sanitation, hygiene, and nutrition interventions (NCT01590095). The sanitation intervention included provision of or upgrades to improved latrines, sani-scoops for feces removal, children's potties, and in-person behavioral promotion. Promotion was intensive up to 2 years after intervention initiation, decreased in intensity between years 2 to 3, and stopped after 3 years. Access to and reported use of latrines was high in both arms, and latrine quality was significantly improved by the intervention, while use of child feces management tools was low. We enrolled a random subset of households from the sanitation and control arms into a longitudinal substudy, which measured child health with quarterly visits between 1 to 3.5 years after intervention implementation. The study period therefore included approximately 1 year of high-intensity promotion, 1 year of low-intensity promotion, and 6 months with no promotion. We assessed intervention effects on diarrhea and ARI prevalence among children Conclusions The observed effect of the WASH Benefits Bangladesh sanitation intervention on diarrhea in children appeared to be sustained for at least 3.5 years after implementation, including 1.5 years after heavy promotion ceased. Existing latrine access was high in the study setting, suggesting that improving on-site latrine quality can deliver health benefits when latrine use practices are in place. Further work is needed to understand how latrine adoption can be achieved and sustained in settings with low existing access and how sanitation programs can adopt transformative approaches of excreta management, including safe disposal of child and animal feces, to generate a hygienic home environment. Trial registration ClinicalTrials.gov; NCT01590095; https://clinicaltrials.gov/ct2/show/NCT01590095., Author(s): Jesse D. Contreras 1, Mahfuza Islam 2, Andrew Mertens 3, Amy J. Pickering 4, Benjamin F. Arnold 5, Jade Benjamin-Chung 6, Alan E. Hubbard 3, Mahbubur Rahman 2, Leanne [...]

Key Points: Question: Does twice-annual mass azithromycin distribution prevent all-cause childhood mortality among children in Burkina Faso aged 1 to 59 months in the setting of seasonal malaria chemoprevention distribution? Findings: In this randomized trial of twice-yearly mass azithromycin distribution, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years) in the azithromycin group compared with 588 deaths over 58 547 person-years (10.0 deaths/1000 person-years) in the placebo group. The difference was not statistically significant. Meaning: Communities with mass azithromycin distribution had lower child mortality than controls, although the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference. Importance: Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions. Objective: To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention. Design, Setting, and Participants: This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities. Interventions: Communities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023. Main Outcomes and Measures: The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census. Results: A total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P =.07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months. Conclusions and Relevance: Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03676764 This cluster randomized placebo-controlled trial examines the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality in rural Burkina Faso. [ABSTRACT FROM AUTHOR]

Abstract Background Estimating the required sample size and statistical power for a study is an integral part of study design. For standard designs, power equations provide an efficient solution to the problem, but they are unavailable for many complex study designs that arise in practice. For such complex study designs, computer simulation is a useful alternative for estimating study power. Although this approach is well known among statisticians, in our experience many epidemiologists and social scientists are unfamiliar with the technique. This article aims to address this knowledge gap. Methods We review an approach to estimate study power for individual- or cluster-randomized designs using computer simulation. This flexible approach arises naturally from the model used to derive conventional power equations, but extends those methods to accommodate arbitrarily complex designs. The method is universally applicable to a broad range of designs and outcomes, and we present the material in a way that is approachable for quantitative, applied researchers. We illustrate the method using two examples (one simple, one complex) based on sanitation and nutritional interventions to improve child growth. Results We first show how simulation reproduces conventional power estimates for simple randomized designs over a broad range of sample scenarios to familiarize the reader with the approach. We then demonstrate how to extend the simulation approach to more complex designs. Finally, we discuss extensions to the examples in the article, and provide computer code to efficiently run the example simulations in both R and Stata. Conclusions Simulation methods offer a flexible option to estimate statistical power for standard and non-traditional study designs and parameters of interest. The approach we have described is universally applicable for evaluating study designs used in epidemiologic and social science research.