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Background: We investigated perceptions of risks in HIV cure clinical research in the United States. We hypothesized that perceived clinical risks, including study procedures, side effects, and social risks affect willingness to participate in research.
Methods: We implemented a cross-sectional survey with 400 American adults living with HIV (22% female; 77% male; < 1% transgender) in 2015. The sample was ethnically diverse (65% Caucasian, 17% African-American, 12% Hispanic, 4% mixed and 2% Asian). Most U.S. states were represented. We also conducted extensive key informant interviews with 36 people living with HIV, as well as numerous researchers, bioethicists, members of IRBs and regulatory agencies to assess perceptions of risks.
Results: Increased cancer risk (49% [95% CI: 42, 52%]; n = 358), developing resistance to ARVs (37% [32, 42%]; n = 358), toxicities (30% [25, 35%]; n = 358) and known risks of stopping HIV medications (30% [25, 35%]; n = 358) were the potential clinical risks most likely to discourage participation. Procedures presenting the greatest barriers were lumbar punctures (26%), bone marrow biopsies (22%), lymph node biopsies (13%), and rectal biopsies (13%). Risk of transmitting HIV in case of unsuspected viral rebound (28% [23, 33%]; n = 358) was the most concerning potential social risk to participation. Additional risks discouraging participation included various clinical risks such as side effects, pain, debilitation, irreversible harm or death, scientific uncertainty, and failure to achieve a cure. Dissuading financial risks included loss of disability insurance or employment. Social risks included disclosure of HIV status, stigma/discrimination, and media attention. The burdens of finding transportation and parking were also significant deterrents to participation. Overall, key informants agreed that the riskiest HIV cure research modalities were stem cell transplants/gene therapy, latency-reversing agents, and combination approaches.
Conclusions: Understanding perceptions of risks is important to inform study design, informed consent, and recruitment and retention strategies for HIV cure-related research. HIV cure clinical researchers should minimize risks to study participants while maximizing scientific knowledge gained. Community and participant confidence regarding the safety of a scalable cure should be a compelling driver for discovery and progress towards a cure.

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