@article{8643ee10187347b7a3d3850ae76a4992,
title = "Development and implementation of participant safety plans for international research with stigmatised populations",
abstract = "People who inject drugs with high-risk sharing practices have high rates of HIV transmission and face barriers to HIV care. Interventions to overcome these barriers are needed; however, stigmatisation of drug use and HIV infection leads to safety concerns during the planning and conduct of research on such interventions. In preparing to address concerns about safety and wellbeing of participants in an international research study, HIV Prevention Trials Network 074, we developed participant safety plans (PSPs) at each site to supplement local research ethics committee oversight, community engagement, and usual clinical trial procedures. The PSPs were informed by systematic local legal and policy assessments, and interviews with key stakeholders. After PSP refinement and implementation, we assessed social impacts at each study visit to ensure continued safety. Throughout the study, five participants reported a negative social impact, with three resulting from study participation. Future research with stigmatised populations should consider using and assessing this approach to enhance safety and welfare.",
author = "Jeremy Sugarman and Mark Barnes and Scott Rose and Kostyantyn Dumchev and Riza Sarasvita and Viet, {Ha Tran} and Oleksandr Zeziulin and Hepa Susami and Vivian Go and Irving Hoffman and Miller, {William C.}",
note = "Funding Information: Acknowledgments, We appreciate the contributions of the experts at each site who prepared reports and did interviews regarding the local legal and policy issues relevant to the research as well as the stakeholders who participated in in-depth interviews. Specifically, in Indonesia, Diah Setia Utami (Indonesia National Narcotics Board) provided information related to current policy; in Ukraine, Iryna Pykalo, Olena Makarenko, and Tetiana Kiriazova (Ukrainian Institute on Public Health Policy, Kiev, Ukraine) did interviews; and in Vietnam, Nguyen Thi Minh Tam (Vietnam Administration for HIV/AIDS Control, Ministry of Health, Hanoi, Vietnam) helped to develop the legal analysis and Nguyen Duc Vuong (Pho Yen Health Center, Thai Nguyen, Vietnam) facilitated interviews. Katie Mollan, Ilana Trumble (University of North Carolina at Chapel Hill, Chapel Hill, NC, USA), and Brett S Hanscom (Fred Hutchinson Cancer Research Center Seattle, WA, USA), assisted with identifying the number of reported negative social impacts and offered feedback on earlier versions of the manuscript. Erica Hamilton (FHI 360, Durham, NC, USA) helped coordinate manuscript reviews. Finally, we would like to thank the participants in HPTN 074 for their invaluable contributions to this research. Publisher Copyright: {\textcopyright} 2018 Elsevier Ltd",
year = "2018",
month = aug,
doi = "10.1016/S2352-3018(18)30073-0",
language = "English (US)",
volume = "5",
pages = "e468--e472",
journal = "The Lancet HIV",
issn = "2352-3018",
publisher = "Elsevier Ltd",
number = "8",
}