Integrating Trauma-Informed Research in Assessment of Young Women Engaged in HIV Cure Research (Post-Intervention Control) Trial with Analytical Treatment Interruption in Durban, South Africa

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7. PROJECT SUMMARY/ABSTRACT Significance: HIV cure has emerged as a global research priority requiring the field to look beyond trials conducted primarily in the US enrolling white men. Participation in cure research that includes prolonged complex visit requirements and analytical treatment interruptions (ATIs) pose not only biological risk, but also social, emotional, and ethical challenges. Understanding barriers to inclusion of key populations in high-HIV burden low- and middle-income countries (LMICs), particularly challenges facing marginalized groups, is critical to designing protocols that promote equitable enrollment of those in greatest need of innovations in HIV cure and treatment. Women remain critically underrepresented in cure research globally. Despite representing 53% of HIV infections worldwide, women represent only 12% of HIV cure research participants. Opportunity: To conduct a socio-behavioral research (SBR) study to assess the experiences of young women enrolled in a first-in-Africa all-female HIV cure trial that includes an ATI, in KwaZulu-Natal, South Africa. The trial will recruit from FRESH, a clinical research site established in 2012 to enroll young women in HIV prevention, early treatment, and HIV cure-related (post-intervention control) research. High intimate partner violence (IPV) is endemic in the region, underscoring the need for trauma-informed research (TIR) and healing-centered design (HCD). Proposal: A SBR study that includes a TIR framework and robust psychosocial support, with study interactions that take place at key points during the trial, including at enrollment, prior to the first dose of study product, before pausing ART during ATI, and after viral rebound. Longitudinal assessments will allow insight into decision making related to trial participation, as well as potential worries around viral rebound, partner protections and disclosure. Inclusion of open-ended discussions will allow sharing of challenges and give social context beyond triggers related to trial participation. The study will also engage non-trial participants and clinical research staff contributing perceptions about HIV cure and trial implementation challenges. Specific Aims: 1) Develop strategies to reduce risks related to enrollment in an HIV cure trial, by characterizing the experiences of 25 trial participants, focusing on their decision-making processes, trial-related concerns (e.g., disclosure, partner protections) and lived experience at key points during the trial. 2) Gain an understanding of the social context and challenges of women enrolled in an HIV cure trial, by quantifying trauma and IPV exposure, self-esteem, resilience, and mental health (anxiety, depression) outcomes in 25 trial participants and 25 non-trial participants living with HIV, and 50 women without HIV. 3) Develop recommendations for safe and ethical enrollment of women in future HIV cure trials in Africa, based on input from 20 clinical research staff about trial implementation, trauma-informed and healing- centered strategies. Expected Outcomes: To achieve an HIV cure globally, research must include key at-risk groups from high-HIV burden LIMCs (e.g., young women in sub-Saharan Africa), underscoring the importance of developing concrete recommendations on trial design, recruitment, informed consent, and retention.