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Background: Air pollution may impair child growth and cognitive development, with potential markers including birth length and head circumference. Methods: The Household Air Pollution Intervention Network (HAPIN) trial was an open label multi-country-randomized controlled trial, with 3200 pregnant women aged 18–34 years (9–19 weeks of gestation) randomly assigned in a 1:1 ratio to receive liquefied petroleum gas (LPG) stove intervention compared to women continuing to cook with solid fuels for 18 months. Particulate matter ≤ 2.5 μm (PM2.5), black carbon (BC) and carbon monoxide (CO) 24-hour personal exposures were measured three times during pregnancy. Head circumference and length were measured

Abstract Background Poor child feces management contributes to enteropathogen exposure and, consequently, is associated with diarrheal disease and negative impacts on child growth. Despite high latrine coverage, only 37% of Indian households safely dispose of their child’s feces into a latrine or have the child use the latrine, with the lowest rate in the state of Odisha at 12%. We evaluated a behavior change and hardware intervention designed to improve caregiver safe disposal of child feces and child latrine use. Methods We conducted a cluster-randomized controlled trial among 74 villages in rural Odisha, India. Eligible villages previously participated in a water and sanitation infrastructure program. Following a baseline survey, half the villages were assigned to intervention and half to control. Caregivers of children

Background: Anemia is common in low- and middle-income countries (LMICs), causing significant health issues and social burdens. Exposure to household air pollution from using biomass fuels for cooking and heating has been associated with anemia, but the exposure–response association has not been studied. Objectives: We evaluated the associations between personal exposure to air pollution and both hemoglobin levels and anemia prevalence among pregnant women in a multi-country randomized controlled trial. Methods: We studied 3,163 pregnant women aged 18–35 years with 9–20 weeks of gestation, recruited as part of the Household Air Pollution Intervention Network (HAPIN) randomized controlled trial in Guatemala, India, Peru, and Rwanda. We assessed 24-hour personal exposures to fine particulate matter (PM2.5), black carbon (BC), and carbon monoxide (CO), and measured hemoglobin levels at baseline (15 ± 3 weeks gestation). Linear and logistic regression models were used to examine the associations of measured pollutants with hemoglobin levels and anemia prevalence, adjusting for confounding. Results: Single-pollutant models showed associations of CO with higher hemoglobin levels and lower anemia prevalence. Bipollutant models involving CO and PM2.5 also revealed that an interquartile range (IQR) increase in CO concentrations (2.26 ppm) was associated with higher hemoglobin levels [β = 0.04; 95 % confidence interval (CI): 0.01, 0.07], and a lower odds of anemia prevalence [odds ratios (OR) = 0.90; 95 % CI: 0.83, 0.98]. PM2.5 was inversely related to hemoglobin and positively associated with anemia, but results were not statistically significant at the 0.05 alpha level. County-specific results showed that 3 of 4 countries showed a similar association between CO and hemoglobin. We found no association of BC levels with hemoglobin levels or with anemia prevalence. Conclusion: Our findings suggest that exposure to CO is associated with higher hemoglobin and lower anemia prevalence among pregnant women, whereas PM2.5 showed the opposite associations.

Background: Reducing household air pollution (HAP) to levels associated with health benefits requires nearly exclusive use of clean cooking fuels and abandonment of traditional biomass fuels. Methods: The Household Air Pollution Intervention Network (HAPIN) trial randomized 3,195 pregnant women in Guatemala, India, Peru, and Rwanda to receive a liquefied petroleum gas (LPG) stove intervention (n = 1,590), with controls expected to continue cooking with biomass fuels (n = 1,605). We assessed fidelity to intervention implementation and participant adherence to the intervention starting in pregnancy through the infant’s first birthday using fuel delivery and repair records, surveys, observations, and temperature-logging stove use monitors (SUMs). Results: Fidelity and adherence to the HAPIN intervention were high. Median time required to refill LPG cylinders was 1 day (interquartile range 0–2). Although 26% (n = 410) of intervention participants reported running out of LPG at some point, the number of times was low (median: 1 day [Q1, Q3: 1, 2]) and mostly limited to the first four months of the COVID-19 pandemic. Most repairs were completed on the same day as problems were reported. Traditional stove use was observed in only 3% of observation visits, and 89% of these observations were followed up with behavioral reinforcement. According to SUMs data, intervention households used their traditional stove a median of 0.4% of all monitored days, and 81% used the traditional stove

Household air pollution from solid cooking fuel use during gestation has been associated with adverse pregnancy and birth outcomes. The Household Air Pollution Intervention Network (HAPIN) trial was a randomized controlled trial of free liquefied petroleum gas (LPG) stoves and fuel in Guatemala, Peru, India, and Rwanda. A primary outcome of the main trial was to report the effects of the intervention on infant birth weight. Here we evaluate the effects of a LPG stove and fuel intervention during pregnancy on spontaneous abortion, postpartum hemorrhage, hypertensive disorders of pregnancy, and maternal mortality compared to women who continued to use solid cooking fuels. Pregnant women (18–34 years of age; gestation confirmed by ultrasound at 9–19 weeks) were randomly assigned to an intervention (n = 1593) or control (n = 1607) arm. Intention-to-treat analyses compared outcomes between the two arms using log-binomial models. Among the 3195 pregnant women in the study, there were 10 spontaneous abortions (7 intervention, 3 control), 93 hypertensive disorders of pregnancy (47 intervention, 46 control), 11 post postpartum hemorrhage (5 intervention, 6 control) and 4 maternal deaths (3 intervention, 1 control). Compared to the control arm, the relative risk of spontaneous abortion among women randomized to the intervention was 2.32 (95% confidence interval (CI): 0.60, 8.96), hypertensive disorders of pregnancy 1.02 (95% CI: 0.68, 1.52), postpartum hemorrhage 0.83 (95% CI: 0.25, 2.71) and 2.98 (95% CI: 0.31, 28.66) for maternal mortality. In this study, we found that adverse maternal outcomes did not differ based on randomized stove type across four country research sites.

Abstract Background Poor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child’s feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices. Methods The intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children

Child feces are an important source of fecal exposure in household environments. Typically, one of two behaviors is necessary to mitigate this risk: either caregivers dispose of their children’s feces into a latrine or children learn how to use a latrine. Although past studies have examined factors associated with these two behaviors collectively (i.e. “safe disposal”), there is a need to separately analyze these distinctive practices to better inform programming. This study aims to quantitatively examine contextual and psychosocial factors influencing caregiver safe disposal and, separately, child latrine training. We surveyed 791 primary female caregivers, who reported on 906 children

Behaviors related to water, sanitation, and hygiene (WASH) are key drivers of infectious disease transmission, and experiences of WASH are potential influencers of mental well-being. Important knowledge gaps exist related to the content and delivery of effective WASH programs and their associated health impacts, particularly within the contexts of government programs implemented at scale. We developed and tested a demand-side intervention called Andilaye, which aimed to change behaviors related to sanitation, personal hygiene, and household environmental sanitation. This theory-informed intervention was delivered through the existing Ethiopian Health Extension Programme (HEP). It was a multilevel intervention with a catalyzing event at the community level and behavior change activities at group and household levels. We randomly selected and assigned 50 kebeles (sub-districts) from three woredas (districts), half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). We collected data on WASH access, behavioral outcomes, and mental well-being. A total of 1,589 households were enrolled into the study at baseline; 1,472 households (94%) participated in an endline assessment two years after baseline, and approximately 14 months after the initiation of a multi-level intervention. The intervention did not improve construction of latrines (prevalence ratio [PR]: 0.99; 95% CI: 0.82, 1.21) or handwashing stations with water (PR: 0.96; 95% CI: 0.72, 1.26), or the removal of animal feces from the compound (PR: 1.10; 95% CI: 0.95, 1.28). Nor did it impact anxiety (PR: 0.90; 95% CI: 0.72, 1.11), depression (PR: 0.83; 95% CI: 0.64, 1.07), emotional distress (PR: 0.86; 95% CI: 0.67, 1.09) or well-being (PR: 0.90; 95% CI: 0.74, 1.10) scores. We report limited impact of the intervention, as delivered, on changes in behavior and mental well-being. The effectiveness of the intervention was limited by poor intervention fidelity. While sanitation and hygiene improvements have been documented in Ethiopia, behavioral slippage, or regression to unimproved practices, in communities previously declared open defecation free is widespread. Evidence from this trial may help address knowledge gaps related to challenges associated with scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. Trial registration: This trial was registered with clinicaltrials.gov (NCT03075436) on March 9, 2017.

Background We compared the relationship of past and contemporary sodium (Na) intake with cardiometabolic biomarkers. Methods and Results A total of 1191 participants' data from a randomized controlled trial in coastal Bangladesh were analyzed. Participants provided 24‐hour urine Na (24UNa) data for 5 monthly visits. Their fasting blood glucose, total cholesterol, triglycerides, high‐density lipoprotein, blood pressure, and 24‐hour urine protein were measured at the fifth visit. Participants' mean 24UNa over the first 4 visits was the past Na, and 24UNa of the fifth visit was the contemporary Na intake. We estimated the prevalence ratios of elevated cardiometabolic biomarkers and metabolic syndrome across 24UNa tertiles by multilevel logistic regression using participant‐, household‐, and community‐level random intercepts. Models were adjusted for age, sex, body mass index, smoking, physical activity, alcohol consumption, sleep hours, religion, and household wealth. Compared with participants in tertile 1 of past urine Na, those in tertile 3 had 1.46 (95% CI, 1.08–1.99) times higher prevalence of prediabetes or diabetes mellitus, 5.49 (95% CI, 2.73–11.01) times higher prevalence of large waist circumference, and 1.60 (95% CI, 1.04–2.46) times higher prevalence of metabolic syndrome. Compared with participants in tertile 1 of contemporary urine Na, those in tertile 3 had 1.93 (95% CI, 1.24–3.00) times higher prevalence of prediabetes or diabetes mellitus, 3.14 (95% CI, 1.45–6.83) times higher prevalence of proteinuria, and 2.23 (95% CI, 1.34–3.71) times higher prevalence of large waist circumference. Conclusions Both past and contemporary Na intakes were associated with higher cardiometabolic disease risk.

Pneumonia is both a treatable and preventable disease but remains a leading cause of death in children worldwide. Household air pollution caused by burning biomass fuels for cooking has been identified as a potentially preventable risk factor for pneumonia in low- and middle-income countries. We are conducting a randomised controlled trial of a clean energy intervention in 3200 households with pregnant women living in Guatemala, India, Peru and Rwanda. Here, we describe the protocol to ascertain the incidence of severe pneumonia in infants born to participants during the first year of the study period using three independent algorithms: the presence of cough or difficulty breathing and hypoxaemia (≤92% in Guatemala, India and Rwanda and ≤86% in Peru); presence of cough or difficulty breathing along with at least one World Health Organization-defined general danger sign and consolidation on chest radiography or lung ultrasound; and pneumonia confirmed to be the cause of death by verbal autopsy. Prior to the study launch, we identified health facilities in the study areas where cases of severe pneumonia would be referred. After participant enrolment, we posted staff at each of these facilities to identify children enrolled in the trial seeking care for severe pneumonia. To ensure severe pneumonia cases are not missed, we are also conducting home visits to all households and providing education on pneumonia to the mother. Severe pneumonia reduction due to mitigation of household air pollution could be a key piece of evidence that sways policymakers to invest in liquefied petroleum gas distribution programmes.

Background We compared the relationship between sodium (Na) intake and blood pressure when Na intake was estimated from first‐ and second‐morning spot urine samples using the INTERSALT (International Study on Salt and Blood Pressure) formula, versus directly measured 24‐hour samples. Methods and Results We collected 24‐hour urine and first‐ and second‐morning voids of 383 participants in coastal Bangladesh for 2 visits. We measured participants’ blood pressure using an Omron® HEM–907 monitor. To assess the shape of the relationship between urinary Na and blood pressure, we created restricted cubic spline plots adjusted for age, sex, body mass index, smoking and alcohol consumption, physical activities, religion, sleep hours, and household wealth. To assess multicollinearity, we reported variance inflation factors, tolerances, and Leamer's and Klein's statistics following linear regression models. The mean daily urinary Na was 122 (SD 26) mmol/d for the first; 122 (SD 27) mmol/d for the second; and 134 (SD 70) mmol/d for the 24‐hour samples. The restricted cubic spline plots illustrated no association between first‐morning urinary Na and systolic blood pressure until the 90th percentile distribution followed by a downward relationship; a nonlinear inverse‐V‐shaped relationship between second‐morning urinary Na and systolic blood pressure; and a monotonic upward relationship between 24‐hour urinary Na and systolic blood pressure. We found no evidence of multicollinearity for the 24‐hour urinary Na model. Conclusions The urinary Na and systolic blood pressure relationship varied for 3 urinary Na measurements. Twenty‐four‐hour urinary Na captured more variability of Na intake compared with spot urine samples, and its regression models were not affected by multicollinearity.

Background Sodium (Na+) in saline water may increase blood pressure (BP), but potassium (K+), calcium (Ca2+), and magnesium (Mg2+) may lower BP. We assessed the association between drinking water salinity and population BP. Methods and Results We pooled 6487 BP measurements from 2 cohorts in coastal Bangladesh. We used multilevel linear models to estimate BP differences across water salinity categories: fresh water (electrical conductivity,

Background: In Rwanda, pneumonia and diarrhea are the first and second leading causes of death, respectively, among children under five. Household air pollution (HAP) resultant from cooking indoors with biomass fuels on traditional stoves is a significant risk factor for pneumonia, while consumption of contaminated drinking water is a primary cause of diarrheal disease. To date, there have been no large-scale effectiveness trials of programmatic efforts to provide either improved cookstoves or household water filters at scale in a low-income country. In this paper we describe the design of a cluster-randomized trial to evaluate the impact of a national-level program to distribute and promote the use of improved cookstoves and advanced water filters to the poorest quarter of households in Rwanda. Methods/Design: We randomly allocated 72 sectors (administratively defined units) in Western Province to the intervention, with the remaining 24 sectors in the province serving as controls. In the intervention sectors, roughly 100,000 households received improved cookstoves and household water filters through a government-sponsored program targeting the poorest quarter of households nationally. The primary outcome measures are the incidence of acute respiratory infection (ARI) and diarrhea among children under five years of age. Over a one-year surveillance period, all cases of acute respiratory infection (ARI) and diarrhea identified by health workers in the study area will be extracted from records maintained at health facilities and by community health workers (CHW). In addition, we are conducting intensive, longitudinal data collection among a random sample of households in the study area for in-depth assessment of coverage, use, environmental exposures, and additional health measures. Discussion: Although previous research has examined the impact of providing household water treatment and improved cookstoves on child health, there have been no studies of national-level programs to deliver these interventions at scale in a developing country. The results of this study, the first RCT of a large-scale programmatic cookstove or household water filter intervention, will inform global efforts to reduce childhood morbidity and mortality from diarrheal disease and pneumonia. Trial registration: This trial is registered at Clinicaltrials.gov (NCT02239250).

Abstract Background In an effort to reduce the disease burden in rural Rwanda, decrease poverty associated with expenditures for fuel, and minimize the environmental impact on forests and greenhouse gases from inefficient combustion of biomass, the Rwanda Ministry of Health (MOH) partnered with DelAgua Health (DelAgua), a private social enterprise, to distribute and promote the use of improved cookstoves and advanced water filters to the poorest quarter of households (Ubudehe 1 and 2) nationally, beginning in Western Province under a program branded Tubeho Neza (“Live Well”). The project is privately financed and earns revenue from carbon credits under the United Nations Clean Development Mechanism. Methods During a 3-month period in late 2014, over 470,000 people living in over 101,000 households were provided free water filters and cookstoves. Following the distribution, community health workers visited nearly 98 % of households to perform household level education and training activities. Over 87 % of households were visited again within 6 months with a basic survey conducted. Detailed adoption surveys were conducted among a sample of households, 1000 in the first round, 187 in the second. Results Approximately a year after distribution, reported water filter use was above 90 % (+/−4 % CI) and water present in filter was observed in over 76 % (+/−6 % CI) of households, while the reported primary stove was nearly 90 % (+/−4.4 % CI) and of households cooking at the time of the visit, over 83 % (+/−5.3 % CI) were on the improved stove. There was no observed association between household size and stove stacking behavior. Conclusions This program suggests that free distribution is not a determinant of low adoption. It is plausible that continued engagement in households, enabled by Ministry of Health support and carbon financed revenue, contributed to high adoption rates. Overall, the program was able to demonstrate a privately financed, public health intervention can achieve high levels of initial adoption and usage of household level water filtration and improved cookstoves at a large scale.

Background Household air pollution (HAP) is a leading environmental risk factor accounting for about 1.6 million premature deaths mainly in low- and middle-income countries (LMICs). However, no multicounty randomized controlled trials have assessed the effect of liquefied petroleum gas (LPG) stove intervention on HAP and maternal and child health outcomes. The Household Air Pollution Intervention Network (HAPIN) was the first to assess this by implementing a common protocol in four LMICs. Objective This manuscript describes the implementation of the HAPIN data management protocol via Research Electronic Data Capture (REDCap) used to collect over 50 million data points in more than 4000 variables from 80 case report forms (CRFs). Methods We recruited 800 pregnant women in each study country (Guatemala, India, Peru, and Rwanda) who used biomass fuels in their households. Households were randomly assigned to receive LPG stoves and 18 months of free LPG supply (intervention) or to continue using biomass fuels (control). Households were followed for 18 months and assessed for primary health outcomes: low birth weight, severe pneumonia, and stunting. The HAPIN Data Management Core (DMC) implemented identical REDCap projects for each study site using shared variable names and timelines in local languages. Field staff collected data offline using tablets on the REDCap Mobile Application. Results Utilizing the REDCap application allowed the HAPIN DMC to collect and store data securely, access data (near real-time), create reports, perform quality control, update questionnaires, and provide timely feedback to local data management teams. Additional REDCap functionalities (e.g. scheduling, data validation, and barcode scanning) supported the study. Conclusions While the HAPIN trial experienced some challenges, REDCap effectively met HAPIN study goals, including quality data collection and timely reporting and analysis on this important global health trial, and supported more than 40 peer-reviewed scientific publications to date.

Introduction Despite clear linkages between provision of clean water and improvements in child health, limited information exists about the health impacts of large water infrastructure improvements in low-income settings. Billions of dollars are spent annually to improve urban water supply, and rigorous evaluation of these improvements, especially targeting informal settlements, is critical to guide policy and investment strategies. Objective measures of infection and exposure to pathogens, and measures of gut function, are needed to understand the effectiveness and impact of water supply improvements.Methods and analysis In the PAASIM study, we examine the impact of water system improvements on acute and chronic health outcomes in children in a low-income urban area of Beira, Mozambique, comprising 62 sub-neighbourhoods and ~26 300 households. This prospective matched cohort study follows 548 mother–child dyads from late pregnancy through 12 months of age. Primary outcomes include measures of enteric pathogen infections, gut microbiome composition and source drinking water microbiological quality, measured at the child’s 12-month visit. Additional outcomes include diarrhoea prevalence, child growth, previous enteric pathogen exposure, child mortality and various measures of water access and quality. Our analyses will compare (1) subjects living in sub-neighbourhoods with the improved water to those living in sub-neighbourhoods without these improvements; and (2) subjects with household water connections on their premises to those without such a connection. This study will provide critical information to understand how to optimise investments for improving child health, filling the information gap about the impact of piped water provision to low-income urban households, using novel gastrointestinal disease outcomes.Ethics and dissemination This study was approved by the Emory University Institutional Review Board and the National Bio-Ethics Committee for Health in Mozambique. The pre-analysis plan is published on the Open Science Framework platform (https://osf.io/4rkn6/). Results will be shared with relevant stakeholders locally, and through publications.

Pit latrines are the most common latrine technology in rural Bangladesh, and untreated effluent from pits can directly contaminate surrounding aquifers. Sand barriers installed around the latrine pit can help reduce contamination but can also alter the decomposition of the fecal sludge and accelerate pit fill-up, which can counteract their benefits. We aimed to evaluate whether there was a difference in decomposition of fecal sludge and survival of soil-transmitted helminth (STH) ova among latrines where a 50-cm sand barrier was installed surrounding and at the bottom of the pit, compared to latrines without a sand barrier, in coastal Bangladesh. We assessed decomposition in latrine pits by measuring the carbon-nitrogen (C/N) ratio of fecal sludge. We enumerated Ascaris lumbricoides and Trichuris trichiura ova in the pit following 18 and 24 months of latrine use. We compared these outcomes between latrines with and without sand barriers using generalized linear models with robust standard errors to adjust for clustering at the village level. The C/N ratio in latrines with and without a sand barrier was 13.47 vs. 22.64 (mean difference: 9.16, 95% CI: 0.15, 18.18). Pits with sand barriers filled more quickly and were reportedly emptied three times more frequently than pits without; 27/34 latrines with sand barriers vs. 9/34 latrines without barriers were emptied in the previous six months. Most reported disposal methods were unsafe. Compared to latrines without sand barriers, latrines with sand barriers had significantly higher log10 mean counts of non-larvated A. lumbricoides ova (log10 mean difference: 0.35, 95% CI: 0.12, 0.58) and T. trichiura ova (log10 mean difference: 0.47, 95% CI: 0.20, 0.73). Larvated ova counts were similar for the two types of latrines for both A. lumbricoides and T. trichiura. Our findings suggest that sand barriers help contain helminth ova within the pits but pits with barriers fill up more quickly, leading to more frequent emptying of insufficiently decomposed fecal sludge. Further research is required on latrine technologies that can both isolate pathogens from the environment and achieve rapid decomposition.

Child feces are an important source of fecal exposure in household environments. Typically, one of two behaviors is necessary to mitigate this risk: either caregivers dispose of their children's feces into a latrine or children learn how to use a latrine. Although past studies have examined factors associated with these two behaviors collectively (i.e. "safe disposal"), there is a need to separately analyze these distinctive practices to better inform programming. This study aims to quantitatively examine contextual and psychosocial factors influencing caregiver safe disposal and, separately, child latrine training. We surveyed 791 primary female caregivers, who reported on 906 children

Behaviors related to water, sanitation, and hygiene (WASH) are key drivers of infectious disease transmission, and experiences of WASH are potential influencers of mental well-being. Important knowledge gaps exist related to the content and delivery of effective WASH programs and their associated health impacts, particularly within the contexts of government programs implemented at scale. We developed and tested a demand-side intervention called Andilaye, which aimed to change behaviors related to sanitation, personal hygiene, and household environmental sanitation. This theory-informed intervention was delivered through the existing Ethiopian Health Extension Programme (HEP). It was a multilevel intervention with a catalyzing event at the community level and behavior change activities at group and household levels. We randomly selected and assigned 50 kebeles (sub-districts) from three woredas (districts), half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). We collected data on WASH access, behavioral outcomes, and mental well-being. A total of 1,589 households were enrolled into the study at baseline; 1,472 households (94%) participated in an endline assessment two years after baseline, and approximately 14 months after the initiation of a multi-level intervention. The intervention did not improve construction of latrines (prevalence ratio [PR]: 0.99; 95% CI: 0.82, 1.21) or handwashing stations with water (PR: 0.96; 95% CI: 0.72, 1.26), or the removal of animal feces from the compound (PR: 1.10; 95% CI: 0.95, 1.28). Nor did it impact anxiety (PR: 0.90; 95% CI: 0.72, 1.11), depression (PR: 0.83; 95% CI: 0.64, 1.07), emotional distress (PR: 0.86; 95% CI: 0.67, 1.09) or well-being (PR: 0.90; 95% CI: 0.74, 1.10) scores. We report limited impact of the intervention, as delivered, on changes in behavior and mental well-being. The effectiveness of the intervention was limited by poor intervention fidelity. While sanitation and hygiene improvements have been documented in Ethiopia, behavioral slippage, or regression to unimproved practices, in communities previously declared open defecation free is widespread. Evidence from this trial may help address knowledge gaps related to challenges associated with scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. Trial registration: This trial was registered with clinicaltrials.gov (NCT03075436) on March 9, 2017.

Introduction Increasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysis RISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.Ethics Study protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration number ACTRN12618000633280; Pre-results.

Introduction Increasing use of cleaner fuels, such as liquefied petroleum gas (LPG), and abandonment of solid fuels is key to reducing household air pollution and realising potential health improvements in low-income countries. However, achieving exclusive LPG use in households unaccustomed to this type of fuel, used in combination with a new stove technology, requires substantial behaviour change. We conducted theory-grounded formative research to identify contextual factors influencing cooking fuel choice to guide the development of behavioural strategies for the Household Air Pollution Intervention Network (HAPIN) trial. The HAPIN trial will assess the impact of exclusive LPG use on air pollution exposure and health of pregnant women, older adult women, and infants under 1 year of age in Guatemala, India, Peru, and Rwanda.Methods Using the Capability, Opportunity, Motivation–Behaviour (COM–B) framework and Behaviour Change Wheel (BCW) to guide formative research, we conducted in-depth interviews, focus group discussions, observations, key informant interviews and pilot studies to identify key influencers of cooking behaviours in the four countries. We used these findings to develop behavioural strategies likely to achieve exclusive LPG use in the HAPIN trial.Results We identified nine potential influencers of exclusive LPG use, including perceived disadvantages of solid fuels, family preferences, cookware, traditional foods, non-food-related cooking, heating needs, LPG awareness, safety and cost and availability of fuel. Mapping formative findings onto the theoretical frameworks, behavioural strategies for achieving exclusive LPG use in each research site included free fuel deliveries, locally acceptable stoves and equipment, hands-on training and printed materials and videos emphasising relevant messages. In the HAPIN trial, we will monitor and reinforce exclusive LPG use through temperature data loggers, LPG fuel delivery tracking, in-home observations and behavioural reinforcement visits.Conclusion Our formative research and behavioural strategies can inform the development, implementation, monitoring and evaluation of theory-informed strategies to promote exclusive LPG use in future stove programmes and research studies.Trial registration number NCT02944682, Pre-results.

The Household Air Pollution Intervention Network (HAPIN) trial is a randomised controlled trial in Guatemala, India, Peru and Rwanda to assess the health impact of a clean cooking intervention in households using solid biomass for cooking. The HAPIN intervention—a liquefied petroleum gas (LPG) stove and 18-month supply of LPG—has significant value in these communities, irrespective of potential health benefits. For control households, it was necessary to develop a compensation strategy that would be comparable across four settings and would address concerns about differential loss to follow-up, fairness and potential effects on household economics. Each site developed slightly different, contextually appropriate compensation packages by combining a set of uniform principles with local community input. In Guatemala, control compensation consists of coupons equivalent to the LPG stove’s value that can be redeemed for the participant’s choice of household items, which could include an LPG stove. In Peru, control households receive several small items during the trial, plus the intervention stove and 1 month of fuel at the trial’s conclusion. Rwandan participants are given small items during the trial and a choice of a solar kit, LPG stove and four fuel refills, or cash equivalent at the end. India is the only setting in which control participants receive the intervention (LPG stove and 18 months of fuel) at the trial’s end while also being compensated for their time during the trial, in accordance with local ethics committee requirements. The approaches presented here could inform compensation strategy development in future multi-country trials.

Summary: Background: Diarrhoea and growth faltering in early childhood are associated with subsequent adverse outcomes. We aimed to assess whether water quality, sanitation, and handwashing interventions alone or combined with nutrition interventions reduced diarrhoea or growth faltering. Methods: The WASH Benefits Bangladesh cluster-randomised trial enrolled pregnant women from villages in rural Bangladesh and evaluated outcomes at 1-year and 2-years' follow-up. Pregnant women in geographically adjacent clusters were block-randomised to one of seven clusters: chlorinated drinking water (water); upgraded sanitation (sanitation); promotion of handwashing with soap (handwashing); combined water, sanitation, and handwashing; counselling on appropriate child nutrition plus lipid-based nutrient supplements (nutrition); combined water, sanitation, handwashing, and nutrition; and control (data collection only). Primary outcomes were caregiver-reported diarrhoea in the past 7 days among children who were in utero or younger than 3 years at enrolment and length-for-age Z score among children born to enrolled pregnant women. Masking was not possible for data collection, but analyses were masked. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCC01590095. Findings: Between May 31, 2012, and July 7, 2013, 5551 pregnant women in 720 clusters were randomly allocated to one of seven groups. 1382 women were assigned to the control group; 698 to water; 696 to sanitation; 688 to handwashing; 702 to water, sanitation, and handwashing; 699 to nutrition; and 686 to water, sanitation, handwashing, and nutrition. 331 (6%) women were lost to follow-up. Data on diarrhoea at year 1 or year 2 (combined) were available for 14 425 children (7331 in year 1, 7094 in year 2) and data on length-for-age Z score in year 2 were available for 4584 children (92% of living children were measured at year 2). All interventions had high adherence. Compared with a prevalence of 5·7% (200 of 3517 child weeks) in the control group, 7-day diarrhoea prevalence was lower among index children and children under 3 years at enrolment who received sanitation (61 [3·5%] of 1760; prevalence ratio 0·61, 95% CI 0·46–0·81), handwashing (62 [3·5%] of 1795; 0·60, 0·45–0·80), combined water, sanitation, and handwashing (74 [3·9%] of 1902; 0·69, 0·53–0·90), nutrition (62 [3·5%] of 1766; 0·64, 0·49–0·85), and combined water, sanitation, handwashing, and nutrition (66 [3·5%] of 1861; 0·62, 0·47–0·81); diarrhoea prevalence was not significantly lower in children receiving water treatment (90 [4·9%] of 1824; 0·89, 0·70–1·13). Compared with control (mean length-for-age Z score −1·79), children were taller by year 2 in the nutrition group (mean difference 0·25 [95% CI 0·15–0·36]) and in the combined water, sanitation, handwashing, and nutrition group (0·13 [0·02–0·24]). The individual water, sanitation, and handwashing groups, and combined water, sanitation, and handwashing group had no effect on linear growth. Interpretation: Nutrient supplementation and counselling modestly improved linear growth, but there was no benefit to the integration of water, sanitation, and handwashing with nutrition. Adherence was high in all groups and diarrhoea prevalence was reduced in all intervention groups except water treatment. Combined water, sanitation, and handwashing interventions provided no additive benefit over single interventions. Funding: Bill & Melinda Gates Foundation.