IntroductionYoung women in sub-Saharan Africa bear a disproportionate HIV burden yet rarely participate in cure-related studies. Analytical treatment interruptions (ATI), used to assess sustained control off therapy, raise clinical, ethical, and psychosocial concerns.MethodsWe conducted a longitudinal qualitative study within a Phase 2A ATI trial (NCT05281510) at the FRESH site in Durban, South Africa. Nineteen women living with HIV (median age 26) completed in-depth interviews at 4 timepoints. We applied framework analysis informed by the Lazarus-Folkman stress and coping model.ResultsParticipants enrolled to contribute to science, reduce pill burden, and due to trust in the clinical team. They anticipated viral rebound, resistance, stigma, and partner transmission. Over time, many reported improved emotional well-being, using meaning-based strategies (pride in contribution) and problem-focused strategies (self-monitoring, condom negotiation). Burdens included stigma, selective disclosure, partner resistance, frequent visits, and blood draws. Benefits included increased HIV literacy, self-management, and comfort with procedures.ConclusionATI-inclusive clinical trials can be acceptable when designs include clear and ongoing education, strong confidentiality protections, mental health and peer support, partner-inclusive risk reductions, and flexible scheduling with practical supports to minimize participation burden and potential psychosocial harms.Clinical trial registrationNCT05281510.
Keywords: HIV cure research; HIV prevention; PrEP; mental health; resource-limited settings; women living with HIV.
Stress and Coping in Young Women During an HIV Cure-Related Trial in Durban, South AfricaYoung women in sub-Saharan Africa are disproportionately affected by HIV, yet they are underrepresented in HIV cure-related studies that include a temporary pause in treatment. This study explored the experiences of 19 young women in Durban, South Africa who participated in a Phase 2A HIV cure-related trial that included an analytical treatment interruption (ATI) under close clinical monitoring. Across interviews conducted from screening through end of the study, participants described specific stressors and shifting views of risk. The ATI period was marked by uncertainty, worry about viral rebound and health impacts, concerns about stigma and unintended disclosure, and fear of transmitting HIV to partners. Participants also described practical burdens from frequent clinic visits and monitoring. Over time, many reported increased confidence as they better understood study procedures and their health indicators, along with improved HIV knowledge and self-management. Participants described coping strategies supported by trusted clinical relationships, social support, planning around visits, and negotiating safer practices. Overall, participants indicated that ATI studies can be acceptable when they include clear and repeated education, strong confidentiality protections, access to mental health and peer support, and flexible scheduling and practical supports that reduce participation burden.