TY - JOUR
T1 - Compensating control participants when the intervention is of significant value
T2 - Experience in Guatemala, India, Peru and Rwanda
AU - Quinn, Ashlinn K.
AU - Williams, Kendra
AU - Thompson, Lisa M.
AU - Rosa, Ghislaine
AU - Díaz-Artiga, Anaité
AU - Thangavel, Gurusamy
AU - Balakrishnan, Kalpana
AU - Miranda, J. Jaime
AU - Rosenthal, Joshua P.
AU - Clasen, Thomas F.
AU - Harvey, Steven A.
N1 - Funding Information:
1Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA 2Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA 3Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA 4Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK 5Centro de Estudios en Salud, Universidad del Valle de Guatemala, Guatemala City, Guatemala 6Department of Environmental Health Engineering, Sri Ramachandra Insitute of Higher Education and Research, Chennai, , India 7CRONICAS Center of Excellence in Chronic Diseases and Department of Medicine, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru 8Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA 9Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA Acknowledgements We thank Dr Joseph Millum (Bioethicist, NIH) for his early guidance on the competing ethical and scientific issues in this matter. We also thank Zoë Sakas and Mayari Hengstermann for their contributions to the HAPIN formative research, the numerous research staff in each IRC and the community participants in formative research. 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. DSMB members: Nalini Sathiakumar, MD, Dr PH (Chair, University of Alabama); Nancy R Cook, ScD (Harvard Medical School); Stephen Hecht, PhD (University of Minnesota); Catherine Karr, MD, PhD (University of Washington); Joseph Millum, PhD (National Institutes of Health, NIH); Paul K. Whelton, MD (Tulane University). NHLBI DSMB members: Katie H. Kavounis, MPH; Dong-Yun Kim, PhD; Lora A Reineck, MD, MS; Gail G Weinmann, MD (DSMB executive secretary). Program Coordination: Gail Rodgers, MD, Bill & Melinda Gates Foundation; Claudia L. Thompson, PhD National Institute of Environmental Health Science (NIEHS); Mark J Parascandola, PhD, MPH, National Cancer Institute (NCI); Danuta M Krotoski, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Joshua P. Rosenthal, PhD Fogarty International Center (FIC), Conception R Nierras, PhD NIH Office of Strategic Coordination Common Fund; Antonello Punturieri, MD, PhD and Barry S Schmetter, National Heart, Lung, and Blood Institute (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:
funding 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].
Publisher Copyright:
© 2019 Author(s).
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - compensation
KW - ethics
KW - multi-country trial
KW - randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85071427518&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071427518&partnerID=8YFLogxK
U2 - 10.1136/bmjgh-2019-001567
DO - 10.1136/bmjgh-2019-001567
M3 - Article
C2 - 31543990
AN - SCOPUS:85071427518
SN - 2059-7908
VL - 4
JO - BMJ Global Health
JF - BMJ Global Health
IS - 4
M1 - e001567
ER -