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

• Type of Material: Article
• Authors: Dana Barr, Emory University; N Puttaswamy, Sri Ramachandra Inst Higher Educ & Res Deemed Uni; LM Jaacks, Harvard TH Chan Sch Publ Hlth; Kyle Steenland, Emory University; S Rajkumar, Sri Ramachandra Inst Higher Educ & Res Deemed Uni; S Gupton, Emory University; P Ryan, Emory University; K Balakrishnan, Sri Ramachandra Inst Higher Educ & Res Deemed Uni; JL Peel, Colorado State University; W Checkley, Johns Hopkins University; Thomas CLASEN, Emory University; Maggie L. Clark, Colorado State University
• Language: English
• Date: 2020-04-01
• Publisher: U.S. Department of Health
• Publication Version: Final Published Version
• Copyright Statement: © 2020 EHP
• License: Creative Commons Universal : Public Domain Dedication
• Final Published Version (URL): http://dx.doi.org/10.1289/EHP5751
• Title of Journal or Parent Work: Environmental Health Perspectives
• Volume: 128
• Issue: 4
• Start Page: 47010
• End Page: 47010
• Grant/Funding Information: The HAPIN trial is funded by the U.S. National Institutes of Health (cooperative agreement 1UM1HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279).; Additional support was provided by Emory’s NIH-funded Human Exposome Research Center (P30ES019776).
• Keywords: Mediation analysis; Cell secretory protein; Environmental Sciences; Life Sciences & Biomedicine; Cross validation; Environmental chemicals; Science & Technology; Toxicology; Lung cancer; Blood lipids; Occupational exposure; Chromatographt mass spectronomy; Ovarian cancer; Environmental Sciences & Ecology; Metabolome wide association; Public, Environmental & Occupational Health
• Research Categories: Health Sciences, Toxicology; Health Sciences, Public Health; Engineering, Environmental; Health Sciences, Occupational Health and Safety

Abstract

BACKGROUND: Biomarkers of exposure, susceptibility, and effect are fundamental for understanding environmental exposures, mechanistic pathways of effect, and monitoring early adverse outcomes. To date, no study has comprehensively evaluated a large suite and variety of biomarkers in household air pollution (HAP) studies in concert with exposure and outcome data. The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India). Their offspring will be followed from birth through 12 months of age to evaluate the role of pre-and postnatal exposure to HAP from biomass burning cookstoves in the control arm and LPG stoves in the intervention arm on growth and respiratory outcomes. In addition, up to 200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes. OBJECTIVES: Here we describe the rationale and ultimate design of a comprehensive biomarker plan to enable us to explore more fully how exposure is related to disease outcome. METHODS: HAPIN enrollment and data collection began in May 2018 and will continue through August 2021. As a part of data collection, dried blood spot (DBS) and urine samples are being collected three times during pregnancy in pregnant women and older adult women. DBS are collected at birth for the child. DBS and urine samples are being collected from the older adult women and children three times throughout the child’s first year of life. Exposure biomarkers that will be longitudinally measured in all participants include urinary hydroxy-polycyclic aromatic hydrocarbons, volatile organic chemical metabolites, metals/metalloids, levoglucosan, and cotinine. Biomarkers of effect, including inflammation, endothelial and oxidative stress biomarkers, lung cancer markers, and other clinically relevant measures will be analyzed in urine, DBS, or blood products from the older adult women. Similarly, genomic/epigenetic markers, microbiome, and metabolomics will be measured in older adult women samples. DISCUSSION: Our study design will yield a wealth of biomarker data to evaluate, in great detail, the link between exposures and health outcomes. In addition, our design is comprehensive and innovative by including cutting-edge measures such as metabolomics and epigenetics.