Program Director/Principal Investigator (Last, First, Middle): Dubé, Karine Project Abstract: HIV cure research is a strategic priority of the National Institutes of Health (NIH), the International AIDS Society (IAS), and the pharmaceutical industry. While there have been over 240 biomedical studies related to HIV cure conducted around the world, and this field of research continues to grow and innovate, there has been limited work dedicated to understanding the motivations and experiences of people living with HIV (PLWHIV) who consider, enter, and participate in these clinical investigations. While preliminary research found a number of factors influence hypothetical participation in HIV cure-related research beyond personal clinical risks, including psychosocial, mental, emotional, logistical, ethical, societal and economic factors, we know little about how PLWHIV understand and experience actual HIV cure research participation, including factors that affect their decision to join, defer, continue or exit these high-risk/low-benefit HIV cure studies. Very little data exist as to participant experiences within HIV cure trials, and how they view these trials after participating. Our multidisciplinary team of social scientists, biomedical HIV cure researchers, and HIV patient advocates proposes to capture participant-centered outcomes longitudinally at critical time points in HIV cure clinical studies being conducted in the U.S. that include diverse populations with respect to sex/gender, health status and chronic/acute HIV status, and transmission groups (e.g. MSM, people who inject drugs (PWIDs). While patient- centered outcomes have been used extensively in HIV treatment, Hepatitis C and oncology, they have yet to be applied to participants of HIV cure research trials. We will integrate novel, longitudinal, mixed-methods assessments into at least three ongoing HIV cure clinical studies at AIDS Clinical Trials Group (ACTG)-affiliated sites: 1) “Last Gift” cohort involving PLWHIV at the end-of-life (EOL) who will interrupt HIV treatment (n=30); 2) ACTG 5345/A5347s (study involving intensively monitored antiretroviral pauses (IMAPs) and extensive tissue biopsies; n=66); 3) ACTG 5366 (latency-reversing study in women; n=30). Studies were selected because biomedical teams sought out this socio-behavioral research and expertise. We propose three specific aims: 1) Quantitatively and qualitatively assess PLWHIV experiences with enrollment into HIV cure clinical studies, including their decision-making processes (e.g., entry vs. non-entry), perceptions of risks and benefits, and understanding of the study; 2) Quantitatively and qualitatively assess how PLWHIV experience prospective participation in HIV cure studies using robust participant-centered outcomes; 3) Develop general and study-specific ethical, practical and tactical recommendations from key stakeholders to inform the design and conduct of future HIV cure studies. We anticipate that particip...