I Know That I Was a Part of Making a Difference: Participant Motivations for Joining a Cure-Directed HIV Trial with an Analytical Treatment Interruption

Analytical treatment interruption (ATI), defined as a closely monitored clinical pause in antiretroviral therapy (ART), is a core component of many HIV cure-directed clinical studies. ATIs may cause significant physical and psychosocial risks for people living with HIV and, as a result, integrating participant and community perspectives into clinical trial designs that include an ATI is crucial to ensuring a successful and person-centered trial. We conducted semi-structured interviews with participants enrolling in the BEAT-2 cure-directed trial (NCT03588715). Interviews elicited participant motivations and decision-making processes for trial participation along with participants' perceptions of the ATI. Interviews were recorded, transcribed, and analyzed using a directed content analysis. Fourteen of 15 trial participants completed interviews. The majority were Black (79%) cisgender male (79%). Participants noted several significant motivating factors contributing to their desire to enroll in the HIV cure-directed clinical trial, the most prominent being a desire to find a cure for HIV and help others in the HIV community. HIV care teams were the most commonly identified resource for patients when making the decision to enroll in the trial, and family, friends, and romantic partners also played a significant role. Altruism was a primary motivation for participation, although participants also shared interest in learning about HIV science and research. Participants had a strong understanding of trial procedures and displayed significant trust in the study team to keep them informed and healthy during their participation. The ATI was a significant source of anxiety for participants. Their primary worry was that their prior antiretroviral therapy (ART) regimen would no longer be effective once they resumed ART. Despite these concerns, participants shared considerable excitement for continued participation in the trial and being a part of the search toward an HIV cure.

Automated summary

Analytical treatment interruption (ATI), a clinical pause in antiretroviral therapy (ART) monitored closely, is an important component of HIV cure-directed clinical studies. This study aimed to understand the motivations and decision-making processes of participants enrolling in the BEAT-2 cure-directed trial, as well as their perceptions of ATI. The majority of participants were driven by a desire to find a cure for HIV and help others in the HIV community. While altruism was a primary motivation, participants also expressed interest in learning about HIV science and research. They displayed a strong understanding of trial procedures and trust in the study team, but also expressed anxiety about the potential ineffectiveness of their previous ART regimen after resuming ART.