Anopheles gambiae Re-Emergence and Resurgent Malaria Transmission in Eastern Rwanda, 2010-2020.

Rwanda achieved unprecedented malaria control gains from 2000 to 2010, but cases increased 20-fold between 2011 and 2017. Vector control challenges and environmental changes were noted as potential explanations, but no studies have investigated causes of the resurgence or identified which vector species drove transmission. We conducted a retrospective study in four sites in eastern Rwanda that conducted monthly entomological surveillance and outpatient malaria care. We compared sporozoite rates, human blood index (HBI), and relative abundance of the primary vectors, Anopheles gambiae and Anopheles arabiensis, from 2017 to 2020. We then modeled the effects of vector control interventions, insecticide resistance, and temperature changes on species composition and reported malaria incidence. Sporozoite rates were 28 times higher and HBI was four times higher in An. gambiae compared with An. arabiensis. Insecticide-treated bed nets, first distributed nationally in 2010, were associated with decreased An. gambiae relative abundance. However, increased pyrethroid resistance was associated with increased An. gambiae relative abundance and malaria incidence. Epidemic malaria peaks corresponded to periods of model-predicted An. gambiae re-emergence, and increased regional air temperatures during the period were further associated with increased malaria incidence. Indoor residual spraying (IRS), implemented with non-pyrethroid insecticides later in the period, was associated with 86% reductions in An. gambiae relative abundance and 75% reductions in malaria incidence. These findings suggest that increased pyrethroid resistance and the re-emergence of An. gambiae were closely linked to the malaria resurgence in eastern Rwanda. Non-pyrethroid IRS or other control measures that effectively target An. gambiae may help prevent future resurgences.

Data management plan and REDCap mobile data capture for a multi-country Household Air Pollution Intervention Network (HAPIN) trial.

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.

Effect of a behavior change and hardware intervention on safe child feces management practices in rural Odisha, India: a cluster-randomized controlled trial.

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 < 5 years old from households with a latrine were eligible to participate. The intervention included five behavior change activities. Hardware was provided at the first activity, based on child age, to aid safe disposal and latrine training (wash basin and bucket with lid for children < 7 months old; latrine training mat platform with removable tray for children 7 to 48 months old). The primary outcome was caregiver reported 'safe disposal' as defined by the WHO/UNICEF Joint Monitoring Programme (JMP) which encompasses two behaviors: caregiver disposal of child's feces into a latrine and child latrine use. Safe disposal was measured four to six months after intervention delivery (endline). RESULTS: Endline analysis included 665 intervention caregivers (840 children) and 634 control caregivers (785 children). Prevalence of JMP-defined safe disposal was 1.16 times greater in the intervention arm compared to control (77.7% vs. 65.9%; prevalence ratio [PR] 1.16, 95% CI 1.04-1.29), with higher prevalence of caregiver safe disposal (18.6% vs. 13.6%; PR 1.46, 95% CI 1.12-1.92) but no significant difference in child latrine use (59.0% vs. 52.2%; PR 1.06, 95% CI 0.95-1.18). When restricted to children < 3 years old, JMP-defined safe disposal was 1.42 times greater (67.5% vs. 46.7%; PR 1.42 95% CI 1.21-1.67) with higher prevalence of both caregiver safe disposal (34.6% vs. 25.7%; PR 1.44, 95% CI 1.11-1.86) and child latrine use (32.9% vs. 20.9%; PR 1.41, 95% CI 1.08-1.83). CONCLUSIONS: The intervention increased JMP-defined safe disposal, with substantial improvements in both caregiver safe disposal and child latrine use among children < 3 years old. While future research is needed to demonstrate sustainability of these effects, our results suggest a potentially scalable intervention for improving child feces disposal and reducing disease. TRIAL REGISTRATION: This trial was retrospectively registered at ISRCTN15831099 on 18/02/2020, which was approximately two months after the first participant was recruited for the baseline survey on 02/12/2019.

Variability in the Timing of Respiratory Syncytial Virus Epidemics in Guatemala, 2008-2018.

BACKGROUND: The description of local seasonality patterns in respiratory syncytial virus (RSV) incidence is important to guide the timing of administration of RSV immunization products. METHODS: We characterized RSV seasonality in Guatemala using the moving epidemic method (MEM) with absolute counts of RSV-associated acute respiratory infections (ARI) from hospital surveillance in Santa Rosa and Quetzaltenango departments of Guatemala. RESULTS: From Week 17 of 2008 through Week 16 of 2018, 8487 ARI cases tested positive for RSV by rRT-PCR. Season onsets varied up to 5 months; early seasons starting in late May to early August and finishing in September to November were most common, but late seasons starting in October to November and finishing in March to April were also observed. Both epidemic patterns had similar durations ranging from 4 to 6 months. Epidemic thresholds (the levels of virus activity that signal the onset and end of a seasonal epidemic) calculated prospectively using previous seasons' data captured between 70% and 99% of annual RSV detections. Onset weeks differed by 2-10 weeks, and offset weeks differed by 2-16 weeks between the two surveillance sites. CONCLUSIONS: Variability in the timing of seasonal RSV epidemics in Guatemala demonstrates the difficulty in precisely predicting the timing of seasonal RSV epidemics based on onset weeks from past seasons and suggests that maximal reduction in RSV disease burden would be achieved through year-round vaccination and immunoprophylaxis administration to at-risk infants.

Factors Determining Black Carbon Exposures among Pregnant Women Enrolled in the HAPIN Trial.

Residential biomass burning is an important source of black carbon (BC) exposure among rural communities in low- and middle-income countries. We collected 7165 personal BC samples and individual/household level information from 3103 pregnant women enrolled in the Household Air Pollution Intervention Network trial. Women in the intervention arm received free liquefied petroleum gas stoves and fuel throughout pregnancy; women in the control arm continued the use of biomass stoves. Median (IQR) postintervention BC exposures were 9.6 µg/m3 (5.2-14.0) for controls and 2.8 µg/m3 (1.6-4.8) for the intervention group. Using mixed models, we characterized predictors of BC exposure and assessed how exposure contrasts differed between arms by select predictors. Primary stove type was the strongest predictor (R2 = 0.42); the models including kerosene use, kitchen location, education, occupation, or stove use hours also provided additional explanatory power from the base model adjusted only for the study site. Our full, trial-wide, model explained 48% of the variation in BC exposures. We found evidence that the BC exposure contrast between arms differed by study site, adherence to the assigned study stove, and whether the participant cooked. Our findings highlight factors that may be addressed before and during studies to implement more impactful cookstove intervention trials.

Human Milk Composition Is Associated with Maternal Body Mass Index in a Cross-Sectional, Untargeted Metabolomics Analysis of Human Milk from Guatemalan Mothers.

Background: Maternal overweight and obesity has been associated with poor lactation performance including delayed lactogenesis and reduced duration. However, the effect on human milk composition is less well understood. Objectives: We evaluated the relationship of maternal BMI on the human milk metabolome among Guatemalan mothers. Methods: We used data from 75 Guatemalan mothers who participated in the Household Air Pollution Intervention Network trial. Maternal BMI was measured between 9 and <20 weeks of gestation. Milk samples were collected at a single time point using aseptic collection from one breast at 6 mo postpartum and analyzed using high-resolution mass spectrometry. A cross-sectional untargeted high-resolution metabolomics analysis was performed by coupling hydrophilic interaction liquid chromatography (HILIC) and reverse phase C18 chromatography with mass spectrometry. Metabolic features associated with maternal BMI were determined by a metabolome-wide association study (MWAS), adjusting for baseline maternal age, education, and dietary diversity, and perturbations in metabolic pathways were identified by pathway enrichment analysis. Results: The mean age of participants at baseline was 23.62 ± 3.81 y, and mean BMI was 24.27 ± 4.22 kg/m2. Of the total metabolic features detected by HILIC column (19,199 features) and by C18 column (11,594 features), BMI was associated with 1026 HILIC and 500 C18 features. Enriched pathways represented amino acid metabolism, galactose metabolism, and xenobiotic metabolic metabolism. However, no significant features were identified after adjusting for multiple comparisons using the Benjamini-Hochberg false discovery rate procedure (FDRBH < 0.2). Conclusions: Findings from this untargeted MWAS indicate that maternal BMI is associated with metabolic perturbations of galactose metabolism, xenobiotic metabolism, and xenobiotic metabolism by cytochrome p450 and biosynthesis of amino acid pathways. Significant metabolic pathway alterations detected in human milk were associated with energy metabolism-related pathways including carbohydrate and amino acid metabolism.This trial was registered at clinicaltrials.gov as NCT02944682.

Cooking with liquefied petroleum gas or biomass and fetal growth outcomes: a multi-country randomised controlled trial.

BACKGROUND: Household air pollution might lead to fetal growth restriction during pregnancy. We aimed to investigate whether a liquefied petroleum gas (LPG) intervention to reduce personal exposures to household air pollution during pregnancy would alter fetal growth. METHODS: The Household Air Pollution Intervention Network (HAPIN) trial was an open-label randomised controlled trial conducted in ten resource-limited settings across Guatemala, India, Peru, and Rwanda. Pregnant women aged 18-34 years (9-19 weeks of gestation) were randomly assigned in a 1:1 ratio to receive an LPG stove, continuous fuel delivery, and behavioural messaging or to continue usual cooking with biomass for 18 months. We conducted ultrasound assessments at baseline, 24-28 weeks of gestation (the first pregnancy visit), and 32-36 weeks of gestation (the second pregnancy visit), to measure fetal size; we monitored 24 h personal exposures to household air pollutants during these visits; and we weighed children at birth. We conducted intention-to-treat analyses to estimate differences in fetal size between the intervention and control group, and exposure-response analyses to identify associations between household air pollutants and fetal size. This trial is registered with ClinicalTrials.gov (NCT02944682). FINDINGS: Between May 7, 2018, and Feb 29, 2020, we randomly assigned 3200 pregnant women (1593 to the intervention group and 1607 to the control group). The mean gestational age was 14·5 (SD 3·0) weeks and mean maternal age was 25·6 (4·5) years. We obtained ultrasound assessments in 3147 (98·3%) women at baseline, 3052 (95·4%) women at the first pregnancy visit, and 2962 (92·6%) at the second pregnancy visit, through to Aug 25, 2020. Intervention adherence was high (the median proportion of days with biomass stove use was 0·0%, IQR 0·0-1·6) and pregnant women in the intervention group had lower mean exposures to particulate matter with a diameter less than 2·5 µm (PM2·5; 35·0 [SD 37·2] µg/m3vs 103·3 [97·9] µg/m3) than did women in the control group. We did not find differences in averaged post-randomisation Z scores for head circumference (0·30 vs 0·39; p=0·04), abdominal circumference (0·38 vs 0·39; p=0·99), femur length (0·44 vs 0·45; p=0·73), and estimated fetal weight or birthweight (-0·13 vs -0·12; p=0·70) between the intervention and control groups. Personal exposures to household air pollutants were not associated with fetal size. INTERPRETATION: Although an LPG cooking intervention successfully reduced personal exposure to air pollution during pregnancy, it did not affect fetal size. Our findings do not support the use of unvented liquefied petroleum gas stoves as a strategy to increase fetal growth in settings were biomass fuels are used predominantly for cooking. FUNDING: US National Institutes of Health and Bill & Melinda Gates Foundation. TRANSLATIONS: For the Kinyarwanda, Spanish and Tamil translations of the abstract see Supplementary Materials section.

Liquefied Petroleum Gas or Biomass Cooking and Severe Infant Pneumonia.

BACKGROUND: Exposure to household air pollution is a risk factor for severe pneumonia. The effect of replacing biomass cookstoves with liquefied petroleum gas (LPG) cookstoves on the incidence of severe infant pneumonia is uncertain. METHODS: We conducted a randomized, controlled trial involving pregnant women 18 to 34 years of age and between 9 to less than 20 weeks' gestation in India, Guatemala, Peru, and Rwanda from May 2018 through September 2021. The women were assigned to cook with unvented LPG stoves and fuel (intervention group) or to continue cooking with biomass fuel (control group). In each trial group, we monitored adherence to the use of the assigned cookstove and measured 24-hour personal exposure to fine particulate matter (particles with an aerodynamic diameter of ≤2.5 µm [PM2.5]) in the women and their offspring. The trial had four primary outcomes; the primary outcome for which data are presented in the current report was severe pneumonia in the first year of life, as identified through facility surveillance or on verbal autopsy. RESULTS: Among 3200 pregnant women who had undergone randomization, 3195 remained eligible and gave birth to 3061 infants (1536 in the intervention group and 1525 in the control group). High uptake of the intervention led to a reduction in personal exposure to PM2.5 among the children, with a median exposure of 24.2 µg per cubic meter (interquartile range, 17.8 to 36.4) in the intervention group and 66.0 µg per cubic meter (interquartile range, 35.2 to 132.0) in the control group. A total of 175 episodes of severe pneumonia were identified during the first year of life, with an incidence of 5.67 cases per 100 child-years (95% confidence interval [CI], 4.55 to 7.07) in the intervention group and 6.06 cases per 100 child-years (95% CI, 4.81 to 7.62) in the control group (incidence rate ratio, 0.96; 98.75% CI, 0.64 to 1.44; P = 0.81). No severe adverse events were reported to be associated with the intervention, as determined by the trial investigators. CONCLUSIONS: The incidence of severe pneumonia among infants did not differ significantly between those whose mothers were assigned to cook with LPG stoves and fuel and those whose mothers were assigned to continue cooking with biomass stoves. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; HAPIN ClinicalTrials.gov number, NCT02944682.).

Effects of a liquefied petroleum gas stove intervention on stillbirth, congenital anomalies and neonatal mortality: A multi-country household air pollution intervention network trial.

Household air pollution (HAP) from cooking with solid fuels used during pregnancy has been associated with adverse pregnancy outcomes. The Household Air Pollution Intervention Network (HAPIN) trial was a randomized controlled trial that assessed the impact of a liquefied petroleum gas (LPG) stove and fuel intervention on health in Guatemala, India, Peru, and Rwanda. Here we investigated the effects of the LPG stove and fuel intervention on stillbirth, congenital anomalies and neonatal mortality and characterized exposure-response relationships between personal exposures to fine particulate matter (PM2.5), black carbon (BC) and carbon monoxide (CO) and these outcomes. Pregnant women (18 to <35 years of age; gestation confirmed by ultrasound at 9 to <20 weeks) were randomly assigned to intervention or control arms. We monitored these fetal and neonatal outcomes and personal exposure to PM2.5, BC and CO three times during pregnancy, we conducted intention-to-treat (ITT) and exposure-response (E-R) analyses to determine if the HAPIN intervention and corresponding HAP exposure was associated with the risk of fetal/neonatal outcomes. A total of 3200 women (mean age 25.4 ± 4.4 years, mean gestational age at randomization 15.4 ± 3.1 weeks) were included in this analysis. Relative risks for stillbirth, congenital anomaly and neonatal mortality were 0.99 (0.60, 1.66), 0.92 (95 % CI 0.52, 1.61), and 0.99 (0.54, 1.85), respectively, among women in the intervention arm compared to controls in an ITT analysis. Higher mean personal exposures to PM2.5, CO and BC during pregnancy were associated with a higher, but statistically non-significant, incidence of adverse outcomes. The LPG stove and fuel intervention did not reduce the risk of these outcomes nor did we find evidence supporting an association between personal exposures to HAP and stillbirth, congenital anomalies and neonatal mortality.

Effects of Cooking with Liquefied Petroleum Gas or Biomass on Stunting in Infants.

BACKGROUND: Household air pollution is associated with stunted growth in infants. Whether the replacement of biomass fuel (e.g., wood, dung, or agricultural crop waste) with liquefied petroleum gas (LPG) for cooking can reduce the risk of stunting is unknown. METHODS: We conducted a randomized trial involving 3200 pregnant women 18 to 34 years of age in four low- and middle-income countries. Women at 9 to less than 20 weeks' gestation were randomly assigned to use a free LPG cookstove with continuous free fuel delivery for 18 months (intervention group) or to continue using a biomass cookstove (control group). The length of each infant was measured at 12 months of age, and personal exposures to fine particulate matter (particles with an aerodynamic diameter of ≤2.5 µm) were monitored starting at pregnancy and continuing until the infants were 1 year of age. The primary outcome for which data are presented in the current report - stunting (defined as a length-for-age z score that was more than two standard deviations below the median of a growth standard) at 12 months of age - was one of four primary outcomes of the trial. Intention-to-treat analyses were performed to estimate the relative risk of stunting. RESULTS: Adherence to the intervention was high, and the intervention resulted in lower prenatal and postnatal 24-hour personal exposures to fine particulate matter than the control (mean prenatal exposure, 35.0 µg per cubic meter vs. 103.3 µg per cubic meter; mean postnatal exposure, 37.9 µg per cubic meter vs. 109.2 µg per cubic meter). Among 3061 live births, 1171 (76.2%) of the 1536 infants born to women in the intervention group and 1186 (77.8%) of the 1525 infants born to women in the control group had a valid length measurement at 12 months of age. Stunting occurred in 321 of the 1171 infants included in the analysis (27.4%) of the infants born to women in the intervention group and in 299 of the 1186 infants included in the analysis (25.2%) of those born to women in the control group (relative risk, 1.10; 98.75% confidence interval, 0.94 to 1.29; P = 0.12). CONCLUSIONS: An intervention strategy starting in pregnancy and aimed at mitigating household air pollution by replacing biomass fuel with LPG for cooking did not reduce the risk of stunting in infants. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; HAPIN ClinicalTrials.gov number, NCT02944682.).

Heat Exposure among Adult Women in Rural Tamil Nadu, India.

Exposure to heat is associated with a substantial burden of disease and is an emerging issue in the context of climate change. Heat is of particular concern in India, which is one of the world's hottest countries and also most populous, where relatively little is known about personal heat exposure, particularly in rural areas. Here, we leverage data collected as part of a randomized controlled trial to describe personal temperature exposures of adult women (40-79 years of age) in rural Tamil Nadu. We also characterize measurement error in heat exposure assessment by comparing personal exposure measurements to the nearest ambient monitoring stations and to commonly used modeled temperature data products. We find that temperatures differ across individuals in the same area on the same day, sometimes by more than 5 °C within the same hour, and that some individuals experience sharp increases in heat exposure in the early morning or evening, potentially a result of cooking with solid fuels. We find somewhat stronger correlations between the personal exposure measurements and the modeled products than with ambient monitors. We did not find evidence of systematic biases, which indicates that adjusting for discrepancies between different exposure measurement methods is not straightforward.

Fidelity and adherence to a liquefied petroleum gas stove and fuel intervention: The multi-country Household Air Pollution Intervention Network (HAPIN) trial.

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 < 1 day per month. Traditional stove use was slightly higher post-COVID-19 (detected on a median [Q1, Q3] of 0.0% [0.0%, 3.4%] of days) than pre-COVID-19 (0.0% [0.0%, 1.6%] of days). There was no significant difference in intervention adherence pre- and post-birth. CONCLUSION: Free stoves and an unlimited supply of LPG fuel delivered to participating homes combined with timely repairs, behavioral messaging, and comprehensive stove use monitoring contributed to high intervention fidelity and near-exclusive LPG use within the HAPIN trial.

Effects of a LPG stove and fuel intervention on adverse maternal outcomes: A multi-country randomized controlled trial conducted by the Household Air Pollution Intervention Network (HAPIN).

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.

Fidelity and adherence to a liquefied petroleum gas stove and fuel intervention: the multi-country Household Air Pollution Intervention Network (HAPIN) trial.

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 <1 day per month. Traditional stove use was slightly higher post-COVID-19 (detected on a median [Q1, Q3] of 0.0% [0.0%, 3.4%] of days) than pre-COVID-19 (0.0% [0.0%, 1.6%] of days). There was no significant difference in intervention adherence pre- and post-birth. Conclusion: Free stoves and an unlimited supply of LPG fuel delivered to participating homes combined with timely repairs, behavioral messaging, and comprehensive stove use monitoring contributed to high intervention fidelity and near-exclusive LPG use within the HAPIN trial.

Study design and rationale for the PAASIM project: a matched cohort study on urban water supply improvements and infant enteric pathogen infection, gut microbiome development and health in Mozambique.

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.

Lung Ultrasound Protocol and Quality Control of Image Interpretation Using an Adjudication Panel in the Household Air Pollution Intervention Network (HAPIN) Trial.

OBJECTIVE: Lung ultrasound (LUS) is an alternative to chest radiography to confirm a diagnosis of pneumonia. For research and disease surveillance, methods to use LUS to diagnose pneumonia are needed. METHODS: In the Household Air Pollution Intervention Network (HAPIN) trial, LUS was used to confirm a clinical diagnosis of severe pneumonia in infants. We developed a standardized definition of pneumonia, protocols for recruitment and training of sonographers, along with LUS image acquisition and interpretation. We use a blinded panel approach to interpretation with LUS cine-loops randomized to non-scanning sonographers with expert review. DISCUSSION: We obtained 357 lung ultrasound scans: 159, 8 and 190 scans were collected in Guatemala, Peru and Rwanda, respectively. The diagnosis of primary endpoint pneumonia (PEP) required an expert tie breaker in 181 scans (39%). PEP was diagnosed in 141 scans (40%), not diagnosed in 213 (60%), with 3 scans (<1%) deemed uninterpretable. Agreement among the two blinded sonographers and the expert reader in Guatemala, Peru and Rwanda was 65%, 62% and 67%, with a prevalence-and-bias-corrected kappa of 0.30, 0.24 and 0.33, respectively. CONCLUSION: Use of standardized imaging protocols, training and an adjudication panel resulted in high confidence for the diagnosis of pneumonia using LUS.

Liquefied Petroleum Gas or Biomass for Cooking and Effects on Birth Weight.

BACKGROUND: Exposure during pregnancy to household air pollution caused by the burning of solid biomass fuel is associated with adverse health outcomes, including low birth weight. Whether the replacement of a biomass cookstove with a liquefied petroleum gas (LPG) cookstove would result in an increase in birth weight is unclear. METHODS: We performed a randomized, controlled trial involving pregnant women (18 to <35 years of age and at 9 to <20 weeks' gestation as confirmed on ultrasonography) in Guatemala, India, Peru, and Rwanda. The women were assigned in a 1:1 ratio to use a free LPG cookstove and fuel (intervention group) or to continue using a biomass cookstove (control group). Birth weight, one of four prespecified primary outcomes, was the primary outcome for this report; data for the other three outcomes are not yet available. Birth weight was measured within 24 hours after birth. In addition, 24-hour personal exposures to fine particulate matter (particles with a diameter of ≤2.5 µm [PM2.5]), black carbon, and carbon monoxide were measured at baseline and twice during pregnancy. RESULTS: A total of 3200 women underwent randomization; 1593 were assigned to the intervention group, and 1607 to the control group. Uptake of the intervention was nearly complete, with traditional biomass cookstoves being used at a median rate of less than 1 day per month. After randomization, the median 24-hour personal exposure to fine particulate matter was 23.9 µg per cubic meter in the intervention group and 70.7 µg per cubic meter in the control group. Among 3061 live births, a valid birth weight was available for 94.9% of the infants born to women in the intervention group and for 92.7% of infants born to those in the control group. The mean (±SD) birth weight was 2921±474.3 g in the intervention group and 2898±467.9 g in the control group, for an adjusted mean difference of 19.6 g (95% confidence interval, -10.1 to 49.2). CONCLUSIONS: The birth weight of infants did not differ significantly between those born to women who used LPG cookstoves and those born to women who used biomass cookstoves. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; HAPIN ClinicalTrials.gov number, NCT02944682.).

Contextual and psychosocial factors influencing caregiver safe disposal of child feces and child latrine training in rural Odisha, India.

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 <5 years old, across 74 villages in rural Odisha, India. At their last defecation event, 38% of children used the latrine and another 10% had their feces safely disposed of into the latrine. Since caregiver safe disposal was rare, we instead assessed safe disposal intention. We used linear regression and multilevel mixed effects models to examine contextual and psychosocial factors. For contextual factors, we found caregivers had stronger safe disposal intention when they came from wealthier households and had greater informational support, but weaker intention when their latrine was near the household. Caregivers more intensely practiced latrine training with their child when they themselves used the latrine for defecation, the latrine was fully intact, and they had greater instrumental support. For psychosocial factors, caregivers had stronger safe disposal intention when their households expected them to practice safe disposal, they felt strongly committed to the behavior, and had a plan for what to do when faced with a water shortage. Caregivers more intensely taught their child how to use the latrine when they believed their child was at risk of becoming sick if they practiced open defecation (OD); viewed child OD as unbeneficial; liked teaching their child; personally felt it was important for the child's father to help; felt confident in their ability to teach their child; and had greater action control over their training practice. Interestingly, caregivers put less effort into latrine training when they felt more concerned for their child's safety when the child defecated outside. These findings underscore the critical need to separately assess unique child feces management (CFM) practices and also provide a road map for practitioners on the types of behavior change strategies to consider in their CFM programming.

Global practices, geographic variation, and determinants of child feces disposal in 42 low- and middle-income countries: An analysis of standardized cross-sectional national surveys from 2016 - 2020.

BACKGROUND: Despite considerable progress improving water and sanitation access globally, unsafe child feces disposal remains common in many low- and middle-income countries (LMICs), posing an important health risk. The present study characterizes the current prevalence of child feces disposal practices and child latrine use across low- and middle-income countries and investigates determinants associated with appropriate disposal practices. METHODS: Data for children ranging from 0 through 4 years of age were analyzed from standardized and nationally-representative surveys of 42 LMICs collected from 2016 to 2020 to assess child feces disposal practices. We report child feces disposal in three categories: disposal in any type of latrine, disposal in an improved latrine, and disposal through means other than in a latrine. Survey weighted multiple Poisson regression models were used to explore factors associated with these practices. RESULTS: Data on 403,036 children (weighted N = 191 million) demonstrated that a minority (40.3%) of children have their feces disposed of in a latrine of any kind, and just 29% have feces disposed of in an improved latrine. Prevalence varied considerably by country and region. In adjusted analyses, both child feces disposal in any latrine and disposal in an improved latrine increased with child age, higher intra-country relative wealth, and urban living, and decreased with breastfeeding and shared sanitation facilities. Disposal in improved latrines additionally increased with access to higher levels of service for drinking water and higher mother's education. Nevertheless, the role of facility access alone was insufficient, as only about half of children with household access to any latrine or improved latrines had their feces disposed of in these facilities. Child latrine use among households with latrine access was also low and highly variable across countries. CONCLUSIONS: Children's feces in LMICs are infrequently disposed of in any latrine type, and even less frequently in improved latrines. In order to minimize health risks in LMICs, increased effort must be undertaken not just to increase sanitation coverage but to address these common barriers to safe child feces disposal and child latrine use.