Risks and Potential Benefits of Participating in Cure Research
By Jeffrey Laurence, M.D.
In order to document whether an intervention designed to cure HIV is successful, an intensively monitored pause of the participant’s antiretroviral treatment (ART) is almost certainly required. Researchers hope that alternatives to stopping ART that accurately predict who is most likely to benefit from a cure strategy will be found, but finding those alternatives will also require monitored pauses in ART. Perceptions of cure trial participants concerning personal and community risks and benefits are relevant to such studies and have received little attention.
A National Institutes of Health trial of people living with HIV taking effective ART in the U.S. and Thailand involved a pause in treatment in order to identify possible markers predicting time to rebound of HIV when no intervention had been administered.
Researchers used a questionnaire to evaluate participant perceptions before and after initiating that pause. Thirty-two individuals at U.S. trial sites were surveyed, half before and half after the ART interruption. All participants saw a social benefit to participation—“Participating moves researchers closer to finding a cure for HIV”—compared to only half of the respondents who believed there would be any direct benefits to them before the pause.
However, in those who were surveyed after the ART pause, 69% thought that there was a direct benefit. In terms of risks of participation, 81% of individuals in both groups reported concern over risks in participating, particularly side effects and physical pain. Participants also reported concern over safety risks related to experiencing a detectable viral load.
The authors concluded that “Key messages pertaining to study-related risks and benefits may need to be clarified or reiterated periodically” in cure-related studies involving planned treatment interruptions. One limitation to generalizing these results is that 75% of the participants were White, non-Hispanic, and all except two were male.
amfAR was a funder of this research.
Dr. Laurence is amfAR’s senior scientific consultant.