Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial

Barr, Dana Boyd; Puttaswamy, Naveen; Jaacks, Lindsay M.; Steenland, Kyle; Rajkumar, Sarah; Gupton, Savannah; Ryan, P. Barry; Balakrishnan, Kalpana; Peel, Jennifer L.; Clasen, Thomas; Clark, Maggie L.; Team, HAPIN Investigative

doi:10.1289/ehp5751

Cited by 29 publications

(19 citation statements)

References 87 publications

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“…Investigators in the Household Air Pollution Intervention Network (HAPIN) trial initially suspended data collection due to the pandemic and have since restarted collection of behavioural, environmental, biological and clinical measurements in the fth year of a ve-year, multi-country trial. [5][6][7][8] HAPIN is a randomized controlled trial in Guatemala, India, Peru, and Rwanda that is assessing the health bene ts of providing lique ed petroleum gas (LPG) stoves and an 18-month supply of free LPG to 3,200 households that otherwise depend on solid biomass fuel (wood, animal dung, or crop residue) for cooking.…”

Section: Introductionmentioning

confidence: 99%

“…Measurements of cooking behavior, personal and in-home exposure to air pollution, biological samples and clinical measurements are being collected longitudinally from pregnant women and their newborns in every household, along with an older adult woman, if present. [5][6][7][8] Our study involves home visits, as well as visits to health centers and hospitals during the woman's pregnancy and the rst year of the child's life.…”

Section: Introductionmentioning

confidence: 99%

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A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Simkovich

Thompson

Clark

et al. 2020

Preprint

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Rationale: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. Objectives: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize integrity of reseach aims while minimizing infection risk based on the latest understanding of the virus. Methods: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. Results: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential aerosolization while performing the activity. One of of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities which can potentially aerosolize the virus are deemed the highest risk. Conclusions: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we can compare trial activities using the same criteria. This approach allows us to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our participants, local communities, and funders. The trial is registered with clinicaltrials.gov (NCT02944682).

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Simkovich

Thompson

Clark

et al. 2020

Preprint

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“…Finally, although our analysis will focus on PM 2:5 as our primary pollutant, black carbon and CO estimates will be incorporated into exposure-response models and may provide new insights into their health implications either as independent predictors or in combination. The exposure measurements will also be evaluated in conjunction with the planned biomarker assessments (e.g., urinary PAHs and levoglucosan) (Boyd Barr et al 2020), allowing mediation analysis to assess whether the biomarkers may be intermediate variables between exposure and health effects.…”

Section: Discussionmentioning

confidence: 99%

“…Here we summarize our methods used for estimating personal exposure for the HAPIN participants. A description of the overall trial methods can be found in the paper by Clasen et al (2020) and a description of the biomarker methods, including repeated measures of biomarkers of exposure [e.g., urinary polycyclic aromatic hydrocarbons (PAHs), levoglucosan], can be found in the paper by Boyd Barr et al (2020). Our methods build on previous efforts while making use of newer approaches and tools with the aim of maximizing the quality and accuracy of personal exposure estimates.…”

Section: Introductionmentioning

confidence: 99%

Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial

Johnson

Steenland

Piedrahita

et al. 2020

Environ Health Perspect

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BACKGROUND: High quality personal exposure data is fundamental to understanding the health implications of household energy interventions, interpreting analyses across assigned study arms, and characterizing exposure-response relationships for household air pollution. This paper describes the exposure data collection for the Household Air Pollution Intervention Network (HAPIN), a multicountry randomized controlled trial of liquefied petroleum gas stoves and fuel among 3,200 households in India, Rwanda, Guatemala, and Peru. OBJECTIVES: The primary objectives of the exposure assessment are to estimate the exposure contrast achieved following a clean fuel intervention and to provide data for analyses of exposure-response relationships across a range of personal exposures. METHODS: Exposure measurements are being conducted over the 3-y time frame of the field study. We are measuring fine particulate matter [PM < 2:5 lm in aerodynamic diameter (PM 2:5)] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children <1 year of age, primarily via multiple 24-h personal assessments (three, six, and three measurements, respectively) over the course of the 18month follow-up period using lightweight monitors. For children we are using an indirect measurement approach, combining data from area monitors and locator devices worn by the child. For a subsample (up to 10%) of the study population, we are doubling the frequency of measurements in order to estimate the accuracy of subject-specific typical exposure estimates. In addition, we are conducting ambient air monitoring to help characterize potential contributions of PM 2:5 exposure from background concentration. Stove use monitors (Geocene) are being used to assess compliance with the intervention, given that stove stacking (use of traditional stoves in addition to the intervention gas stove) may occur. CONCLUSIONS: The tools and approaches being used for HAPIN to estimate personal exposures build on previous efforts and take advantage of new technologies. In addition to providing key personal exposure data for this study, we hope the application and learnings from our exposure assessment will help inform future efforts to characterize exposure to household air pollution and for other contexts.

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“…Using urine and DBS collected at regular intervals from the pregnant woman, older adult woman, and child (Table 1), the Biomarker Center will: a) assess repeated measures, including targeted biomarkers of exposure, biomarkers of tobacco smoke exposure, biomarkers of effect that are predictive of clinical outcomes, and exploratory analyses that include metabolomics, mRNA, miRNA, and DNA methylation; b) perform HAP-specific biomarker development and validation; c) create and operate a biospecimen repository; and d) create a data set for deposit in the National Institutes of Health (NIH) BioLINCC repository and ensure that study procedures are compatible with that program's requirements for biospecimen collection, labeling, and storage. Biomarker sampling methodologies are described in detail elsewhere (Barr et al 2020;Hu et al 2000;Liu et al 2014).…”

Section: Biomonitoringmentioning

confidence: 99%

Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution

Clasen

Checkley

Peel

et al. 2020

Environ Health Perspect

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BACKGROUND: Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority residing in low-and middle-income countries (LMICs). The resulting household air pollution (HAP) is a leading environmental risk factor, accounting for an estimated 1.6 million premature deaths annually. Previous interventions of cleaner stoves have often failed to reduce exposure to levels that produce meaningful health improvements. There have been no multicountry field trials with liquefied petroleum gas (LPG) stoves, likely the cleanest scalable intervention. OBJECTIVE: This paper describes the design and methods of an ongoing randomized controlled trial (RCT) of LPG stove and fuel distribution in 3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda). METHODS: We are enrolling 800 pregnant women at each of the 4 international research centers from households using biomass fuels. We are randomly assigning households to receive LPG stoves, an 18-month supply of free LPG, and behavioral reinforcements to the control arm. The mother is being followed along with her child until the child is 1 year old. Older adult women (40 to <80 years of age) living in the same households are also enrolled and followed during the same period. Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman. Secondary health outcomes are also being assessed. We are assessing stove and fuel use, conducting repeated personal and kitchen exposure assessments of fine particulate matter with aerodynamic diameter ≤2:5 lm (PM 2:5), carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis. Enrollment and data collection began in May 2018 and will continue through August 2021. The trial is registered with ClinicalTrials.gov (NCT02944682). CONCLUSIONS: This study will provide evidence to inform national and global policies on scaling up LPG stove use among vulnerable populations.

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Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial

Cited by 29 publications

References 87 publications

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial

Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution

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