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Helminth and protozoan infections affect more than 1 billion children globally. Improving water quality, sanitation, handwashing, and nutrition could be more sustainable control strategies for parasite infections than mass drug administration, while providing other quality of life benefits. We enrolled geographic clusters of pregnant women in rural western Kenya into a cluster-randomized controlled trial (ClinicalTrials.gov NCT01704105) that tested 6 interventions: water treatment, improved sanitation, handwashing with soap, combined water treatment, sanitation, and handwashing (WSH), improved nutrition, and combined WSH and nutrition (WSHN). We assessed intervention effects on parasite infections by measuring Ascaris lumbricoides, Trichuris trichiura, hookworm, and Giardia duodenalis among children born to the enrolled pregnant women (index children) and their older siblings. After 2 years of intervention exposure, we collected stool specimens from 9,077 total children aged 2 to 15 years in 622 clusters, including 2,346 children in an active control group (received household visits but no interventions), 1,117 in the water treatment arm, 1,160 in the sanitation arm, 1,141 in the handwashing arm, 1,064 in the WSH arm, 1,072 in the nutrition arm, and 1,177 in the WSHN arm. In the control group, 23% of children were infected with A. lumbricoides, 1% with T. trichiura, 2% with hookworm, and 39% with G. duodenalis. The analysis included 4,928 index children (median age in years: 2) and 4,149 older siblings (median age in years: 5); study households had an average of 5 people, <10% had electricity access, and >90% had dirt floors. Compared to the control group, Ascaris infection prevalence was lower in the water treatment arm (prevalence ratio [PR]: 0.82 [95% CI 0.67, 1.00], p = 0.056), the WSH arm (PR: 0.78 [95% CI 0.63, 0.96], p = 0.021), and the WSHN arm (PR: 0.78 [95% CI 0.64, 0.96], p = 0.017). We did not observe differences in Ascaris infection prevalence between the control group and the arms with the individual interventions sanitation (PR: 0.89 [95% CI 0.73, 1.08], p = 0.228), handwashing (PR: 0.89 [95% CI 0.73, 1.09], p = 0.277), or nutrition (PR: 86 [95% CI 0.71, 1.05], p = 0.148). Integrating nutrition with WSH did not provide additional benefit. Trichuris and hookworm were rarely detected, resulting in imprecise effect estimates. No intervention reduced Giardia. Reanalysis of stool samples by quantitative polymerase chain reaction confirmed the reductions in Ascaris infections measured by microscopy in the WSH and WSHN groups. Trial limitations included imperfect uptake of targeted intervention behaviors, limited power to detect effects on rare parasite infections, and that it was not feasible to blind participants and sample collectors to treatment status. However, lab technicians and data analysts were blinded to treatment status. The trial was funded by the Bill & Melinda Gates Foundation and the United States Agency for International Development. Integration of improved water quality, sanitation, and handwashing could contribute to sustainable control strategies for Ascaris infections, particularly in similar settings with recent or ongoing deworming programs. Combining nutrition with WSH did not provide further benefits, and water treatment alone was similarly effective to integrated WSH. Our findings provide new evidence that drinking water should be given increased attention as a transmission pathway for Ascaris. ClinicalTrials.gov NCT01704105.

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

A previous cluster-randomized controlled trial in Bangladesh found that individual or combined water, handwashing, sanitation, and nutrition interventions during pregnancy and after birth improved developmental outcomes of children at 1 and 2 years of age. In this study, we aimed to determine if these intervention effects were sustained for children at school age. Clusters of pregnant women were enrolled between May 31, 2012 and July 7, 2013 and block-randomized into chlorinated drinking water (W); improved sanitation (S); handwashing with soap (H); combined WSH; nutrition counseling and provision of lipid-based supplements (N); combined WSH + N, or a double-sized passive control arm (C) with no intervention visits (N = 5,551). The primary outcomes of the main trial after the 2-year intervention were 7-day diarrhea prevalence and length-for-age z-score, measured in 4,584 children of enrolled pregnant women. We conducted a post hoc, follow-up of all initially enrolled mothers and their children 5 years after intervention completion, when children were 7 years old. Primary outcomes were child cognition assessed using the Wechsler Pre and Primary Scale of Intelligence (WPPSI-IV), along with assessments of fine motor abilities, behavior, school achievement, and executive function; secondary outcomes were maternal mental health and stimulation in the home environment. We conducted intention-to-treat analyses using generalized linear models to calculate unadjusted and adjusted comparisons between each arm and the control group, accounting for block-level clustering. Between September 2019 and February 2021, we re-enrolled 4,175 households from all 720 original clusters, with the full set of child development assessments conducted on 3,833 children across 718 clusters. Children in the WSH + N, N, and S arms had improved cognitive scores on one or more domains compared to the control arm, with adjusted effect sizes between 0.10 (95%CI: 0.00, 0.20) and 0.15 (0.03, 0.27). Children in the W, H, N, WSH, and WSH + N arms demonstrated improved prosocial behaviors (adjusted effect sizes between 0.20 (0.07, 0.33) and 0.31 (0.16, 0.46)) and reduced difficult behaviors (adjusted effect sizes between -0.15 (-0.28, -0.01) and -0.31 (-0.45, -0.17)). No intervention effects were observed for fine motor, executive functioning, or school achievement outcomes. Maternal depressive symptoms were improved in the WSH + N, H, and N arms (adjusted effect sizes between -0.14 (-0.24, -0.03) and -0.21 (-0.31, -0.11)), and the stimulating home environment was improved in all intervention arms (adjusted effect sizes between 0.17 (0.01, 0.33) and 0.40 (0.25, 0.56)). Children whose families had higher wealth at baseline and those who were male tended to have larger effect sizes on the FSIQ. Data collection for this study was interrupted by a 6-month pause at the start of the COVID-19 pandemic. The main limitation of this study is loss to follow-up. At 7 years of age, we found small, sustained benefits of early water, sanitation, handwashing, and nutrition interventions on child cognitive and socioemotional outcomes, the stimulating home environment, and maternal mental health. Future work to determine the mechanisms underlying these intervention effects will further inform the design of early interventions to improve child health and development. Trial registration: Follow-up trial: ClinicalTrials.gov, NCT04443855. Original WASH-Benefits Bangladesh (WASH-B): ClinicalTrials.gov, NCT01590095.

While water, sanitation, and hygiene (WASH) interventions can reduce diarrheal disease, many large-scale trials have not found the expected health gains for young children in low-resource settings. Evidence-based guidance is needed to improve interventions and remove barriers to diarrheal disease reduction. We aimed to estimate how sensitive WASH intervention effectiveness was to underlying contextual and intervention factors in the WASH Benefits (WASH-B) Bangladesh cluster-randomized controlled trial. The investigators measured diarrheal prevalence in children enrolled in the WASH-B trial at three time points approximately 1 year apart ( observations). We developed a susceptible-infectious-susceptible model with transmission across multiple environmental pathways and evaluated each of four interventions [water (W), sanitation (S), hygiene (H), and nutrition (N) applied individually and in combination], compliance with interventions, and the impact of individuals not enrolled in the study. Leveraging a set of mechanistic parameter combinations fit to the WASH-B Bangladesh trial using a hybrid Bayesian sampling-importance resampling and maximum-likelihood estimation approach, we simulated trial outcomes under counterfactual scenarios to estimate how changes in six WASH factors (preexisting WASH conditions, disease transmission potential, intervention compliance, intervenable fraction of transmission, intervention efficacy, and community coverage) impacted intervention effectiveness. Increasing community coverage had the greatest impact on intervention effectiveness (e.g., median increases in effectiveness of 34.0 and 45.5 percentage points in the WSH and WSHN intervention arms when increasing coverage to 20%). The effect of community coverage on effectiveness depended on how much transmission was along pathways not modified by the interventions. Intervention effectiveness was reduced by lower levels of preexisting WASH conditions or increased baseline disease burden. Individual interventions had complementary but not synergistic effects when combined. To realize the expected health gains, future WASH interventions must address community coverage and transmission along pathways not traditionally covered by WASH. The effectiveness of individual-level WASH improvements is reduced more the further the community is from achieving the coverage needed for herd protection. https://doi.org/10.1289/EHP15200.

To examine the effects of poor sanitation and hygiene on the prevalence of antimicrobial-resistant bacteria, we surveyed households in two rural and two urban communities in Guatemala (N = 196 randomly selected households). One adult (≥ 18-years old) and, when available, one child (≤ 5 years-old) provided a stool sample. Up to 48 presumptive Escherichia coli isolates were collected from each stool sample (n = 21,256 total) and were subjected to breakpoint assays for ten antibiotics. Mixed-effects logistic models were used to identify potential factors influencing the likelihood of harboring antibiotic-resistant bacteria. For nine out of ten antibiotics, the odds of detecting resistant bacteria decreased by ~ 32% (odds ratios, OR 0.53–0.8, P < 0.001) for every unit of improvement of a hygiene scale. Hygiene differences between households had a greater impact on prevalence compared to antibiotic use differences. The likelihood of detecting resistant isolates was lower for five antibiotics among households that boiled raw milk before consumption (OR 0.31–0.69), and higher for nine antibiotics in urban households (OR > 1.89–9.6). Poor hygiene conditions likely obscure effects of individual antibiotic use, presumably due to enhanced microbial transmission. Consequently, efforts to improve antibiotic stewardship should be coupled with improving hygiene conditions.

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. 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 <5 years through intention-to-treat analysis using generalized linear models with robust standard errors. Masking was not possible during data collection, but data analysis was masked. We enrolled 720 households (360 per arm) from the parent trial and made 9,800 child observations between June 2014 and December 2016. Over the entire study period, diarrheal prevalence was lower among children in the sanitation arm (11.9%) compared to the control arm (14.5%) (prevalence ratio [PR] = 0.81, 95% CI 0.66, 1.00, p = 0.05; prevalence difference [PD] = -0.027, 95% CI -0.053, 0, p = 0.05). ARI prevalence did not differ between sanitation (21.3%) and control (22.7%) arms (PR = 0.93, 95% CI 0.82, 1.05, p = 0.23; PD = -0.016, 95% CI -0.043, 0.010, p = 0.23). There were no significant differences in intervention effects between periods with high-intensity versus low-intensity/no promotion. Study limitations include use of caregiver-reported symptoms to define health outcomes and limited data collected after promotion ceased. 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. ClinicalTrials.gov; NCT01590095; https://clinicaltrials.gov/ct2/show/NCT01590095.

Background School-based water, sanitation and hygiene (WASH) may improve the health and attendance of schoolchildren, particularly post-menarcheal girls, but existing evidence is mixed. We examined the impact of an urban school-based WASH programme (Project WISE) on child health and attendance. Methods The WISE cluster-randomised trial, conducted in 60 public primary schools in Addis Ababa, Ethiopia over one academic year, enrolled 2–4 randomly selected classes per school (~ 100 pupils) from grades 2 to 8 (aged 7–16) in an ‘open cohort’. Schools were assigned 1:1 by stratified randomisation to receive the intervention during the 2021/2022 or the 2022/2023 academic year (waitlist control). The intervention included improvements to drinking water storage, filtration and access, handwashing stations and behaviour change promotion. Planned sanitation improvements were not realised. At four unannounced classroom visits post-intervention (March–June 2022), enumerators recorded primary outcomes of roll-call absence, and pupil-reported respiratory illness and diarrhoea in the past 7 days among pupils present. Analysis was by intention-to-treat. Results Of 83 eligible schools, 60 were randomly selected and assigned. In total, 6229 eligible pupils were enrolled (median per school 101.5; IQR 94–112), 5987 enrolled at study initiation (23rd November–22nd December 2021) and the remaining 242 during follow-up. Data were available on roll-call absence for 6166 pupils (99.0%), and pupil-reported illness for 6145 pupils (98.6%). We observed a 16% relative reduction in odds of pupil-reported respiratory illness in the past 7 days during follow-up in intervention vs. control schools (aOR 0.84; 95% CI 0.71–1.00; p  = 0.046). There was no evidence of effect on pupil-reported diarrhoea in the past 7 days (aOR 1.15; 95% CI 0.84–1.59; p  = 0.39) nor roll-call absence (aOR 1.07; 95% 0.83–1.38; p  = 0.59). There was a small increase in menstrual care self-efficacy (aMD 3.32 on 0–100 scale; 95% CI 0.05–6.59), and no evidence of effects on other secondary outcomes. Conclusions This large-scale intervention to improve school WASH conditions city-wide had a borderline impact on pupil-reported respiratory illness but no effect on diarrhoeal disease nor pupil absence. Future research should establish relationships between WASH-related illness, absence and other educational outcomes. Trial registration ClinicalTrials.gov, number NCT05024890.

Diarrhea and growth faltering in early childhood reduce survival and impair neurodevelopment. We assessed whether a national program combining (i) funds for latrine and water upgrades; (ii) institutional strengthening; and (iii) behavior change campaigns reduced diarrhea and stunting, and strengthened local institutions. We collaborated with program implementers to conduct a cluster-randomized controlled trial in four provinces of the Democratic Republic of Congo (DRC). Three hundred thirty-two rural villages were grouped into 121 clusters to minimize geographic spillovers. Between 15 March and 30 June 2018, we randomly assigned, after stratifying by province and cluster size, 50 intervention and 71 control clusters. Masking of participants and interviewers was not possible. Primary outcomes were length-for-age Z-score among children under 5 years of age, caregiver-reported diarrhea in last 7 days among children under 5 years of age, and an index of community WASH institutions. The primary analysis was on an intention-to-treat basis, using a binary variable indicating whether the participant was in an intervention or control cluster. Three thousand two hundred eighty-three households were interviewed between November 2022 and April 2023, median 3.6 years post-intervention. The intervention had no effect on diarrhea (adjusted mean difference -0.01 [95% -0.05 to 0.03]). Diarrhea prevalence was high overall, at 38% in the treatment group and 42% in the control group. The intervention had no effect on length-for-age Z-scores in children (adjusted mean difference -0.01 [95% CI -0.15 to 0.12]). In the control group, the mean length-for-age Z-score was -2.18 (1.60 SD). Villages in the intervention group had a 0.40 higher score on the WASH institutions index (95% CI 0.16-0.65). The percentage of villages in the intervention group with an active water, sanitation, and hygiene (or just water) committee was 21 pp higher than the control group. Households in the intervention group were 24 pp (95% CI 12-36) more likely to report using an improved water source, 18 pp (95% CI 10-25) more likely to report using an improved sanitation facility, and reported more positive perceptions of water governance (adjusted difference 0.19 SD [95% CI 0.04-0.34]). The trial had several limitations, including incomplete (86%) adherence in the implementation group, the absence of baseline measures, and the reliance on self-reported outcomes for some measures. The DRC's national rural WASH program increased access to improved water and sanitation infrastructure, and created new WASH institutions, all of which persisted for at least 3.6 years. However, these effects were not sufficient to reduce diarrhea or growth faltering. The Pan African Clinical Trials Registry PACTR202102616421588 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14670). The American Economics Association RCT registry AEARCTR-0004648 (https://www.socialscienceregistry.org/trials/4648).

This study evaluated the impact of packaged interventions for operation and maintenance (O&M) on the usability and cleanliness of toilets in public schools in the Philippines. In this cluster-randomized controlled trial, the divisions of Roxas City and Passi City were randomly assigned to the intervention or control group. Schools in Roxas City (n = 14) implemented the packaged O&M interventions; schools in Passi City (n = 16) formed the control group. Outcome variables were toilet usability—defined as accessible, functional and private—and toilet cleanliness, measured using the Sanitation Assessment Tool (SAT) and the Cleaner Toilets, Brighter Future (CTBF) instruments at baseline and at four months follow-up through direct observation of school toilets. SAT results showed that intervention schools had a 32.0% (4.6%; 59.3%) higher percentage of usable toilets than control schools at follow-up after full adjustment (p = 0.024). CTBF results found a similar result, although this was not statistically significant (p = 0.119). The percentage of toilets that were fully clean was 27.1% (3.7%; 50.6%) higher in intervention schools than in control schools after adjustment (p = 0.025). SAT results also showed an improvement in cleanliness of toilets in intervention schools compared to those in controls, but this did not remain significant after adjustment. The findings indicate that the additional implementation of O&M interventions can further stimulate progress towards reaching Water, Sanitation and Hygiene service levels aligned with the Sustainable Development Goals.