Ethical Approval and Dissemination: The study protocol was reviewed and approved by institutional review boards (IRBs) or Ethics Committees at Emory University (00089799), Johns Hopkins University (00007403), Sri Ramachandra Institute of Higher Education and Research (IEC-N1/16/JUL/54/49) and the Indian Council of Medical Research – Health Ministry Screening Committee (5/8/4-30/(Env)/Indo-US/2016-NCD-I), Universidad del Valle de Guatemala (146-08-2016/11-2016) and Guatemalan Ministry of Health National Ethics Committee (11-2016), A.B. PRISMA, the London School of Hygiene and Tropical Medicine (11664-5) and the Rwandan National Ethics Committee (No.357/RNEC/2018), and Washington University in St. Louis (201611159).
Funding: This study is funded by the U.S. National Institutes of Health (cooperative agreement 1UM1HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279). Participating NIH organizations include the National Heart, Lung and Blood Institute, National Institute of Environmental Health Sciences, National Cancer Institute, National Institute of Child Health and Human Development, Fogarty International Center, and the NIH Common Fund. Suzanne M. Simkovich was supported by funding from the National Heart, Lung and Blood Institute T32 HL007534-36, the National Heart, Lung, and Blood Institute 1F32HL143909-01, the National Heart, Lung, and Blood Institute K12HL137942. Lindsay J. Underhill and Kendra Williams were supported by Research Training Grant D43TW009340 (MPIs: Buekens, Checkley, Chi, Kondwani) funded by United States National Institutes of Health through the following Institutes and Centers: Fogarty International Center, National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, National Heart, Lung, and Blood Institute and the National Institute of Environmental Health Sciences along with the National Heart, Lung, and Blood Institute 1F32HL143909-01.
Role of Study Sponsor: Program officials participated in regular conference calls, made recommendations about study design and participated in final decision-making on the trial study protocol; however, they had no role in the writing of this report or decision to submit it for publication. The corresponding authors share final responsibility for the decision to submit for publication.
Data Availability Statement: Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.
Competing Interests: No authors have competing interests.
Contributions: SS & JR conceptualized design of the tool, built the tool, completed the risk assessment of each activity, provided scientific input to assess each activity and wrote the manuscript. LT and MC built the tool, provided scientific input to assess each activity and participated in the writing of the manuscript.TC, WC, AL, JP oversaw the trial’s decisions in risk and benefit and the building of the risk assessment tool and provided comments to the writing of the manuscript. KB, AB, WC, TC, VDR, ADA, LF, SH, MK, AL, EM, JP, AQ, GR, provided scientific input into the design of the tool, reviewed and provided input on each activity, and provided comments to the writing of the manuscript. LU, KW, BY provided scientific input into the design of the tool, completed the assessment of activities, provided scientific input on the tool and provided comments to the writing of the manuscript.
All Authors have reviewed and approved the final manuscript.
Acknowledgements: 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. NHLBI DSMB: Nancy R. Cook, Sc.D.; Stephen Hecht, Ph.D.; Catherine Karr, M.D., Ph.D.; Katie H. Kavounis, M.P.H.; Dong-Yun Kim, Ph.D.; Joseph Millum, Ph.D.; Lora A. Reineck, M.D., M.S.; Nalini Sathiakumar, M.D., Dr.P.H.; Paul K. Whelton, M.D.; Gail G. Weinmann, M.D.
Program Coordination: Gail Rodgers, M.D., Bill & Melinda Gates Foundation; Claudia L. Thompson, Ph.D., National Institute of Environmental Health Science (NIEHS); Mark J. Parascandola, Ph.D., M.P.H., National Cancer Institute (NCI); Danuta M. Krotoski, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Joshua P. Rosenthal, Ph.D., Fogarty International Center (FIC); Conception R. Nierras, Ph.D., NIH Office of Strategic Coordination Common Fund; Antonello Punturieri, M.D., Ph.D. and Barry S. Schmetter, B.S., 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 U.S. National Institutes of Health or Department of Health and Human Services.
HAPIN Investigators: Vigneswari Aravindalochanan, Kalpana Balakrishnan, Dana Boyd Barr, Vanessa Burrowes, Devan Campbell, Julia McPeek Campbell, Eduardo Canuz, Adly Castañaza, Howard Chang, William Checkley, Yunyun Chen, Marilú Chiang, Maggie L. Clark, Thomas Clasen, Rachel Craik, Mary Crocker, Victor Dávila-Román, Lisa de las Fuentes, Oscar De Léon, Anaité Diaz-Artiga, Ephrem Dusabimana, Lisa Elon, Juan Gabriel Espinoza, Irma Sayury Pineda Fuentes, Sarada Garg, Dina Goodman, Savannah Gupton, Meghan Hardison, Stella Hartinger, Steven A. Harvey, Mayari Hengstermann, Phabiola Herrera, Shakir Hossen, Penelope Howards, Lindsay Jaacks, Shirin Jabbarzadeh, Michael A. Johnson, Abigail Jones, Katherine Kearns, Miles Kirby, Jacob Kremer, Margaret Laws, Patricia M. Lenzen, Jiawen Liao, Amy Lovvorn, Fiona Majorin, Eric McCollum, John P. McCracken, Rachel M. Meyers, J. Jaime Miranda, Erick Mollinedo, Lawrence Moulton, Krishnendu Mukhopadhyay, Luke Naeher, Abidan Nambajimana, Florien Ndagijimana, Azhar Nizam, Jean de Dieu Ntivuguruzwa, Aris Papageorghiou, Jennifer Peel, Ricardo Piedrahita, Ajay Pillarisetti, Naveen Puttaswamy, Elisa Puzzolo, Ashlinn Quinn, Sarah Rajkumar, Usha Ramakrishnan, Davis Reardon, Ghislaine Rosa, Joshua Rosenthal, P. Barry Ryan, Zoe Sakas, Sankar Sambandam, Jeremy Sarnat, Suzanne Simkovich, Sheela Sinharoy, Kirk R. Smith, Kyle Steenland, Damien Swearing, Gurusamy Thangavel, Lisa M. Thompson, Ashley K. Toenjes, Lindsay Underhill, Jean Damascene Uwizeyimana, Viviane Valdes, Amit Verma, Lance Waller, Megan Warnock, Kendra Williams, Wenlu Ye, Bonnie N. Young
The Healthcare Delivery Network at Medstar Health Research Institute supported the submission of this manuscript as Suzanne M. Simkovich transferred her affiliation.