Stress and Coping During an HIV Cure-Related Trial with an Analytical Treatment Interruption: A Qualitative Assessment of the Experiences of Young Women in Durban, South Africa

Abstract

Introduction: Young 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. Methods: We 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. Results: Participants 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. Conclusion: ATI-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 registration: NCT05281510