PROJECT SUMMARY In this R34 application (PAR-23-060, Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes), we propose to develop and pilot test an integrated intervention that addresses the dual and interconnected priorities of mental health and HIV medication adherence. This research responds to the global public health calls to enhance HIV intervention science for MSM who experience growing HIV prevalence and the highest HIV incidence rates in sub-Saharan Africa. Despite South Africa national campaigns to provide HIV prevention medication (daily PrEP) and treatment medication (ART) to this population, growing evidence points to suboptimal adherence to these efficacious biomedical interventions among MSM communities, and underscores a need for medication adherence programs targeting this group. Common mental health problems such as depression are also prevalent among MSM, and untreated mental health problems are strongly associated with poor adherence to PrEP and ART. There are emerging indications that interventions providing targeted and integrated mental health treatment and adherence support can impact both outcomes in general populations in sub-Saharan Africa, but there is need to develop and evaluate MSM-focused programs. The proposed intervention, currently titled WeCare, will be based on principles of problem-solving therapy, minority stress theory, and a status-neutral approach which includes MSM in mental health and adherence interventions regardless of HIV status in order to optimize reach and impact, minimize stigma, and enhance support in this community. We will use a three-phase research approach to address our specific aims. First, we will conduct formative qualitative research to develop an intervention approach targeting mental health and HIV medication adherence support, and that is responsive to the social context and minority stressors in this key population. Second, we will conduct an open pilot to refine and finalize the intervention manual and research protocol. Third, we will conduct a randomized pilot trial to test the intervention compared to an enhanced standard of care control. Participants in the pilot trial will be assessed at baseline, 3-months, and 6-months post-enrollment. We will assess intervention effects on primary outcomes including a mental health, biologically confirmed medication adherence; exploratory secondary outcomes including self-report medication adherence, PrEP persistence, and interest in long-acting PrEP and ART; exploratory theoretical mediators including multidimensional stigma (internalized, anticipated, enacted, concealment), social support, and positive identity. We will also conduct qualitive assessment to examine intervention characteristics that can optimize further implementation and scalability. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined mental health and medication adherence i...