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Ethics Hum Res. 2019 Sep;41(5):28-34. doi: 10.1002/eahr.500030.

Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs.

Author information

1
Harvey M. Meyerhoff professor of bioethics and medicine at the Berman Institute of Bioethics and the Department of Medicine at Johns Hopkins University.
2
Research assistant and PhD student in the Department of Biostatistics and Informatics at the Colorado School of Public Health.
3
Clinical research manager with the HPTN Leadership and Operations Center at FHI 360.
4
Director of Strengthening Government-based Rehabilitation Centre of the Indonesia National Narcotics Board.
5
Scientific director at the Ukrainian Institute on Public Health Policy.
6
Investigator of record of HPTN 074 in Pho Yen CRS Vietnam and a research assistant professor in the Department of Health Behavior at the University of North Carolina Gillings School of Public Health.
7
Professor of medicine and the director of international operations for the University of North Carolina Institute of Global Health and Infectious Diseases.
8
Professor in and the chair of the Division of Epidemiology in the College of Public Health at The Ohio State University.
9
Biostatistician with the Statistical Center for HIV Research and Prevention in Seattle.

Abstract

Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. We evaluated participant-reported benefits in a trial conducted in Indonesia, Ukraine, and Vietnam that assessed an intervention combining psychosocial counseling and referral for antiretroviral therapy and substance use treatment for HIV-infected people who use drugs. Reported benefits were aggregated into three groups: clinical (antiretroviral therapy, reduced cravings, reduced drug use, lab testing, medical referral, mental health, physical health), social (employment, financial, relationships, reduced stigma), and general (gained knowledge, life improvement). Overall, 438 index participants (90.5%) and 642 injection partners (83.1%) reported at least one benefit. Significantly more index participants who received the study intervention reported at least one benefit versus those who received the standard of care. Clinical trial participation can provide broad direct and indirect benefits for stigmatized populations, which has implications for assessing the ethical appropriateness of studies with such populations.

KEYWORDS:

HIV clinical trials; Human subjects research; people who inject drugs; research benefits; research risks

PMID:
31541541
DOI:
10.1002/eahr.500030

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