Background:
Most HIV cure-directed clinical trials require an analytical treatment interruption (ATI) to test the efficacy of interventions aimed at keeping HIV suppressed in the absence of antiretroviral treatment (ART). Little is known about how people with HIV (PWH) articulate or feel about having experienced extended ATIs.
Methods:
From April – August 2022, we conducted two sequential qualitative interviews with participants in the BEAT-HIV-02 (NCT03588715) HIV cure-directed trial testing a combination of immunotherapy (peg-IFN-ɑ2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) given for 26 weeks after ART interruption. Immunotherapy was followed by up to an additional 24-week follow-up ATI until ART re-start criteria was met. Interviews took place at study baseline and immediately after completion of study ATI when re-start ART criteria were met. Interviews elicited participant experiences during the ATI and the trial in general. Interviews were recorded, transcribed, and analyzed using directed content analysis.
Results:
In total, 13 PWH, 77% male, 77% Black, completed sequential interviews. The mean ATI was 38 weeks in duration. Participants viewed the ATI as positive because they appreciated a respite from daily medication. Some reported increased self-confidence when their counts remained low during the ATI, before viral rebound. However, when viral counts rose, some expressed feelings of fear, frustration, anger and despair. Three expressed disappointment that they were not cured of their HIV. Rising viral loads led some to feel a sense of failure. All participants reported a positive and trusting relationship with the clinical trial team. Reciprocal respectful relationships between participants and study staff were noted as helping to mitigate participants’ safety concerns.
Conclusions:
Our socio-behavioral study identifies key points for intervention and participant support during HIV cure-directed studies including an extended ATI. Managing expectations, focusing on participants’ contributions, and providing support to reduce feelings of having failed the research team and/or the HIV community following viral rebound should be part of study design. Continued efforts to understand how PWH experience ATIs will improve future designs of HIV cure-directed clinical trials.
Key Themes and Representative Quotes