TY - JOUR
T1 - Design and rationale of the biomarker center of the household air pollution intervention network (Hapin) trial
AU - HAPIN Investigative Team
AU - Barr, Dana Boyd
AU - Puttaswamy, Naveen
AU - Jaacks, Lindsay M.
AU - Steenland, Kyle
AU - Rajkumar, Sarah
AU - Gupton, Savannah
AU - Ryan, P. Barry
AU - Balakrishnan, Kalpana
AU - Peel, Jennifer L.
AU - Checkley, William
AU - Clasen, Thomas
AU - Clark, Maggie L.
N1 - Funding Information:
Program Coordination: G. Rodgers, Bill & Melinda Gates Foundation; C.L. Thompson, National Institute of Environmental Health Science; M.J. Parascandola, National Cancer Institute; D.M. Krotoski and M. Koso-Thomas, Eunice Kennedy Shriver National Institute of Child Health and Human Development; J.P. Rosenthal, Fogarty International Center; C.R. Nierras, NIH Office of Strategic Coordination Common Fund; K. Kavounis, D. Kim, A. Punturieri, and B.S. Schmetter, NHLBI. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US National Institutes of Health or Department of Health and Human Services.
Funding Information:
We thank N. Rothman and Q. Lan from the National Institutes of Health (NIH) National Cancer Institute (NCI) for their advice and discussions regarding the novel biomarkers to be measured in Peru and Guatemala. 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). A multidisciplinary, independent Data and Safety Monitoring Board (DSMB) appointed by the National Heart, Lung, and Blood Institute (NHLBI) monitors the quality of the data and protects the safety of patients enrolled in the HAPIN trial. Members of the NHLBI DSMB: N.R. Cook, S. Hecht, C. Karr, J. Millum, N. Sathiakumar (Chair), P.K. Whelton, and G.G. Weinmann (Executive Secretary). Program Coordination: G. Rodgers, Bill & Melinda Gates Foundation; C.L. Thompson, National Institute of Environmental Health Science; M.J. Parascandola, National Cancer Institute; D.M. Krotoski and M. Koso-Thomas, Eunice Kennedy Shriver National Institute of Child Health and Human Development; J.P. Rosenthal, Fogarty International Center; C.R. Nierras, NIH Office of Strategic Coordination Common Fund; K. Kavounis, D. Kim, A. Punturieri, and B.S. Schmetter, NHLBI. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US National Institutes of Health or Department of Health and Human Services.
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). A multidisciplinary, independent Data and Safety Monitoring Board (DSMB) appointed by the National Heart, Lung, and Blood Institute (NHLBI) monitors the quality of the data and protects the safety of patients enrolled in the HAPIN trial.
Publisher Copyright:
© 2020, Public Health Services, US Dept of Health and Human Services. All rights reserved.
PY - 2020/4
Y1 - 2020/4
N2 - 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. https://doi.org/10.1289/EHP5751.
AB - 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. https://doi.org/10.1289/EHP5751.
UR - http://www.scopus.com/inward/record.url?scp=85084208342&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85084208342&partnerID=8YFLogxK
U2 - 10.1289/EHP5751
DO - 10.1289/EHP5751
M3 - Article
C2 - 32347765
AN - SCOPUS:85084208342
SN - 0091-6765
VL - 128
JO - Environmental health perspectives
JF - Environmental health perspectives
IS - 4
M1 - 047010
ER -