Compensating control participants when the intervention is of significant value: experience in Guatemala, India, Peru and Rwanda.

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

Correction: The use of bluetooth low energy Beacon systems to estimate indirect personal exposure to household air pollution

An amendment to this paper has been published and can be accessed via a link at the top of the paper

Designing a comprehensive behaviour change intervention to promote and monitor exclusive use of liquefied petroleum gas stoves for the Household Air Pollution Intervention Network (HAPIN) trial.

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

LPG stove and fuel intervention among pregnant women reduce fine particle air pollution exposures in three countries: Pilot results from the HAPIN trial

The Household Air Pollution Intervention Network trial is a multi-country study on the effects of a liquefied petroleum gas (LPG) stove and fuel distribution intervention on women's and children's health. There is limited data on exposure reductions achieved by switching from solid to clean cooking fuels in rural settings across multiple countries. As formative research in 2017, we recruited pregnant women and characterized the impact of the intervention on personal exposures and kitchen levels of fine particulate matter (PM2.5) in Guatemala, India, and Rwanda. Forty pregnant women were enrolled in each site. We measured cooking area concentrations of and personal exposures to PM2.5 for 24 or 48 h using gravimetric-based PM2.5 samplers at baseline and two follow-ups over two months after delivery of an LPG cookstove and free fuel supply. Mixed models were used to estimate PM2.5 reductions. Median kitchen PM2.5 concentrations were 296 μg/m3 at baseline (interquartile range, IQR: 158-507), 24 μg/m3 at first follow-up (IQR: 18-37), and 23 μg/m3 at second follow-up (IQR: 14-37). Median personal exposures to PM2.5 were 134 μg/m3 at baseline (IQR: 71-224), 35 μg/m3 at first follow-up (IQR: 23-51), and 32 μg/m3 at second follow-up (IQR: 23-47). Overall, the LPG intervention was associated with a 92% (95% confidence interval (CI): 90-94%) reduction in kitchen PM2.5 concentrations and a 74% (95% CI: 70-79%) reduction in personal PM2.5 exposures. Results were similar for each site. CONCLUSIONS: The intervention was associated with substantial reductions in kitchen and personal PM2.5 overall and in all sites. Results suggest LPG interventions in these rural settings may lower exposures to the WHO annual interim target-1 of 35 μg/m3. The range of exposure contrasts falls on steep sections of estimated exposure-response curves for birthweight, blood pressure, and acute lower respiratory infections, implying potentially important health benefits when transitioning from solid fuels to LPG

Developing Visual Messages to Support Liquefied Petroleum Gas Use in Intervention Homes in the Household Air Pollution Intervention Network (HAPIN) Trial in Rural Guatemala.

BackgroundHousehold air pollution adversely affects human health and the environment, yet more than 40% of the world still depends on solid cooking fuels. The House Air Pollution Intervention Network (HAPIN) randomized controlled trial is assessing the health effects of a liquefied petroleum gas (LPG) stove and 18-month supply of free fuel in 3,200 households in rural Guatemala, India, Peru, and Rwanda.AimsWe conducted formative research in Guatemala to create visual messages that support the sustained, exclusive use of LPG in HAPIN intervention households.MethodWe conducted ethnographic research, including direct observation (n = 36), in-depth (n = 18), and semistructured (n = 6) interviews, and 24 focus group discussions (n = 96) to understand participants' experience with LPG. Sixty participants were selected from a pilot study of LPG stove and 2-months of free fuel to assess the acceptability and use of LPG. Emergent themes were used to create visual messages based on observations and interviews in 40 households; messages were tested and revised in focus group discussions with 20 households.ResultsWe identified 50 codes related to household air pollution and stoves; these were reduced into 24 themes relevant to LPG stoves, prioritizing 12 for calendars. Messages addressed fear and reluctance to use LPG; preference of wood stoves for cooking traditional foods; sustainability and accessibility of fuel; association between health outcomes and household air pollution; and the need for inspirational and aspirational messages.DiscussionWe created a flip chart and calendar illustrating themes to promote exclusive LPG use in HAPIN intervention households

Does household air pollution from cooking fires affect infant neurodevelopment? Developing methods in the NACER pilot study in rural Guatemala

Background: Worldwide, 3 billion people are exposed to household air pollution from cooking fires. One of the top two risk factors among neonates, household air pollution greatly affects neonatal morbidity and mortality. In low-resource countries, neurodevelopmental impairments are often not identified during the neonatal period, leading to permanent disability. No published studies have examined the effect of household air pollution exposures on neurodevelopmental impairments in infants. The NACER study in rural Guatemala aims to measure personal exposures to household air pollution during pregnancy and infancy and to train birth attendants to collect standardised measures of infant neurodevelopment. Methods: Guatemalan indigenous women from rural communities were recruited from a health centre at less than 20 weeks' gestation and received prenatal health exams at less than 20 weeks, 24–28 weeks, and 32–36 weeks. The study was conducted between January, 2012, and December, 2013. Home visits were made three times during pregnancy to monitor prenatal exposures to carbon monoxide (particulate matter; PM2·5) and polycyclic aromatic hydrocarbons. Home visits were made within 48 h of birth and at 1, 3, 6, 9, and 12 months to assess household air pollution exposures and measure infant neurodevelopment with a validated 27-item instrument (Rapid Neurodevelopmental Assessment) developed in Bangladesh for use with semi-skilled health workers and adapted in Guatemala for use with traditional birth attendants. We report on household air pollution and results from Rapid Neurodevelopmental Assessment from the prenatal and neonatal periods. Findings: 37 pregnant women were enrolled and there were 31 liveborn infants. Gestational age was confirmed by fetal ultrasound (mean 15·2 weeks, range 7–20·1). Five (11%) households used open fires for cooking, whereas 33 (89%) used deteriorated chimney stoves. Mean 15-min maximum exposure to carbon monoxide were 16·9 parts per million (ppm, SD 12·4) during the prenatal period and 13·3 ppm (SD 23·4) during the neonatal. Mean 48-h PM2·5 concentrations were 130·2 μg/m3 (SD 65·3) during pregnancy and 63·8 μg/m3 (SD 17·3) during the neonatal period. 27% of infants were low birthweight (<2500 g) and 8% were preterm (<37 weeks). Of neonates, moderate/severe neurodevelopmental impairments, as defined by the Rapid Neurodevelopmental Assessment cutoff points, were identified in eight domains: fine motor (n=4, 13%), gross motor (10, 32%), speech (5, 16%), cognition (5, 16%), behaviour (4,13%), vision (1, 3%), hearing (6, 19%), and primitive reflexes (7, 23%). Interpretation: Maternal exposures to household air pollution were higher than were neonatal exposures, but both were higher than WHO recommended guidelines. Low birthweight and moderate/severe neurodevelopmental impairment were high. Pilot data will be used to develop a future, randomised stove intervention study to measure the effect of reduced exposures to household air pollution on low birthweight, preterm delivery, and infant neurodevelopmental impairment. Funding: University of California, National Center for Advancing Translational Sciences, National Institutes of Health

Determining gestational age and preterm birth in rural Guatemala: A comparison of methods

<div><p>Background</p><p>Preterm birth is the leading cause of death among children <5 years of age. Accurate determination of prematurity is necessary to provide appropriate neonatal care and guide preventive measures. To estimate the most accurate method to identify infants at risk for adverse outcomes, we assessed the validity of two widely available methods—last menstrual period (LMP) and the New Ballard (NB) neonatal assessment—against ultrasound in determining gestational age and preterm birth in highland Guatemala.</p><p>Methods</p><p>Pregnant women (n = 188) were recruited with a gestational age <20 weeks and followed until delivery. Ultrasound was performed by trained physicians and LMP was collected during recruitment. NB was performed on infants within 96 hours of birth by trained study nurses. LMP and NB accuracy at determining gestational age and identifying prematurity was assessed by comparing them to ultrasound.</p><p>Results</p><p>By ultrasound, infant mean gestational age at birth was 38.3 weeks (SD = 1.6) with 16% born at less than 37 gestation. LMP was more accurate than NB (mean difference of +0.13 weeks for LMP and +0.61 weeks for NB). However, LMP and NB estimates had low agreement with ultrasound-determined gestational age (Lin’s concordance<0.48 for both methods) and preterm birth (κ<0.29 for both methods). By LMP, 18% were judged premature compared with 6% by NB. LMP underestimated gestational age among women presenting later to prenatal care (0.18 weeks for each additional week). Gestational age for preterm infants was overestimated by nearly one week using LMP and nearly two weeks using NB. New Ballard neuromuscular measurements were more predictive of preterm birth than those measuring physical criteria.</p><p>Conclusion</p><p>In an indigenous population in highland Guatemala, LMP overestimated prematurity by 2% and NB underestimated prematurity by 10% compared with ultrasound estimates. New, simple and accurate methods are needed to identify preterm birth in resource-limited settings worldwide.</p></div

Sociodemographic characteristics of study participants.

<p>Sociodemographic characteristics of study participants.</p

Gestational age distributions by NB, LMP and ultrasound.

<p>The vertical line indicates 37 weeks, the threshold between term and preterm births (y-axis is the kernel density of the gestational age distribution for each method).</p

Performance of LMP and Ballard to determine gestational age at birth compared to ultrasound.

<p>Performance of LMP and Ballard to determine gestational age at birth compared to ultrasound.</p