Personal Clinical Benefits in HIV Cure Trials: Unlikely But Motivating
Regulators and HIV cure researchers in the United States concur that early cure studies have little chance of conferring direct clinical benefits on volunteers, according to the results of in-depth interviews. But high proportions of U.S. HIV-positive survey respondents saw diverse clinical benefits -- as well as benefits to society and to science -- as factors that would motivate them to participate in cure studies, according to the study poster presented at AIDS 2016.
AIDS service organization workers and academic collaborators conducted an online cross-sectional survey of 400 HIV-positive adults in 38 U.S. states in September and October 2015. They also completed in-depth interviews with 36 HIV-positive people, researchers, bioethicists and members of institutional review boards and regulatory agencies to assess perceived benefits. The survey required respondents to rank the importance of factors that would motivate them to consider participating in HIV cure studies as very important, somewhat important, barely important, not important and don't know/not applicable. Most survey respondents, 77%, were men. The ethnically diverse group was 65% white, 17% African-American, 12% Hispanic, 2% Asian and 4% mixed race/ethnicity.
The three leading "very important" potential clinical benefits that would motivate people to enroll in cure studies were preserving the immune system's ability to fight HIV (92%), reducing HIV in reservoirs or the entire body (85%) and controlling viral load in the absence of treatment (84%). The three top "very important" potential personal benefit motivators were feeling good about contributing to HIV cure research (80%), gaining knowledge about one's own health or HIV (78%) and learning about new treatment options (77%). The leading "very important" potential social benefit motivators were helping find a cure for HIV (95%), helping other people with HIV in the future (90%) and contributing to scientific knowledge (88%).
During in-depth interviews, regulators and clinician-researchers agreed that early HIV cure trials are unlikely to provide direct clinical benefits to participants. These experts stressed that participants may perceive indirect benefits that motivate them to volunteer for cure studies. During these interviews, potential volunteers listed diverse motivating factors, including feeling empowered, reducing stigma, bolstering advocacy work and ensuring participation of under-represented populations.
The researchers who conducted the survey offered several recommendations, starting with the responsibility of researchers "to report the associated lack of clinical benefits in early-phase HIV cure studies." To that end, informed-consent forms should "clearly distinguish between benefits to society and benefits to participants." The survey team called for more empirical research on actual benefits of participating in cure studies.