Expectations of preventative benefits and risk behaviors in a randomized trial evaluating oral HIV preexposure prophylaxis candidates

ABSTRACT

When participants enrolled in an HIV prevention trial hold a preventive misconception (PM) – expectations that experimental interventions will confer protection from HIV infection – they may engage in behaviors that increase their risk of acquiring HIV. This can raise ethical concerns about whether those enrolled in the trial understand the nature of participation and their safety. Consequently, we systematically evaluated the prevalence of PM and its association with risk behaviors in a trial examining three candidate regimens for oral HIV pre-exposure prophylaxis in which all participants received at least one antiretroviral agent. Overall, trial participants exhibited relatively high preventive expectations that may be associated with an increase in risk behaviors among men who have sex with men. In addition, we identified substantial site variability in PM that necessitates future research to uncover its source. This will allow appropriate measures to be taken to mitigate PM and help ensure that participants have an accurate understanding of the potential risks and benefits of trial participation throughout the course of a trial.

KEYWORDS:

• HIV prevention
• behaviors
• preventive misconception
• ethics

Sustainable Development Goals:

• SDG 3: Good health and well-being

Acknowledgements

The authors thank the study participants, sites and the HPTN 069/ACTG 5305 Study Team for making this study possible. Jeremy Sugarman, Kevin Weinfurt and Brian Weir were involved with the conception and design of this article. Brian Weir, Chen Dun, and Kevin Weinfurt contributed to the analysis and interpretation of the data. Jeremy Sugarman, Brian Weir and Kevin Weinfurt drafted the paper, which was critically revised for intellectual content and finally approved for publication by all authors. All authors agree to be accountable for all aspects of the work.

Disclosure statement

Jeremy Sugarman is a member of Merck KGaA’s Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; and a consultant to Merck. None of these activities are related to the material discussed in this manuscript. Kenneth Mayer’s institution has received unrestricted research grants from Gilead Sciences and Merck Inc and has served on Scientific Advisory Boards. His institution is currently funded by an unrestricted research grant from ViiV Healthcare. Timothy Wilkin has received grant support (paid to Weill Cornell Medicine) from Gilead, GlaxoSmithKline, ViiV Healthcare and Merck. He has served as an ad hoc consultant for GlaxoSmithKline/ViiV and Merck. Brian Weir, Chen Dun, Roy M. Gulick, and Kevin Weinfurt have nothing to disclose.

Additional information

Funding

This work was supported by the National Institute of Mental Health (NIMH) under grant R21MH092253. In addition, HPTN 069/ACTG 5305 provided support through collaboration. The HPTN 069 study was supported by the HIV Prevention Trials Network (HPTN) and by cooperative agreements from the National Institute of Allergy and Infectious Diseases (NIAID) to the HPTN Leadership and Operations Center (UM1AI068619), the HPTN Laboratory Center (UM1AI068613), and the HPTN Statistical and Data Management Center (UM1AI068617). ACTG5305 was supported by NIAID under grants U01AI068636 and UM1AI068636 and by NIMH and the National Institute of Dental and Craniofacial Research (NIDCR). Gilead and Viiv provided study medications. The sponsor had no role in the study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIMH, NIAID, NIDCR, or the National Institutes of Health (NIH).