Implementing an Evidence-Based Trauma Treatment with Community-led PrEP Navigation for Transgender and Gender Diverse Individuals Affected by Violence and HIV. - HIV prevalence remains high among individuals at elevated risk in the Ending the HIV Epidemic priority jurisdiction of Los Angeles County. HIV pre-exposure prophylaxis (PrEP) is an evidence-based innovation and a cornerstone of both the local HIV Prevention Plan, and the national Ending the HIV Epidemic “Prevent” pillar. Despite this, PrEP uptake and persistence remain low, particularly among populations disproportionately impacted by HIV. Barriers to PrEP use include unstable housing, financial hardship, exposure to violence, and associated mental health burdens such as depression and posttraumatic stress disorder (PTSD). These challenges have been documented across multiple studies as well as in our own preliminary work in Los Angeles County. To address these barriers, there is an urgent need for multilevel implementation strategies that improve and accelerate PrEP uptake and persistence. Our community–academic research partnership will build on the PrEP Well, a multiyear California HIV/AIDS Research Program–funded implementation science project, which has expanded access to PrEP services through a community-based health center in Los Angeles County. Preliminary findings from PrEP Well indicate that mental health burdens related to trauma, violence, and chronic stress remain significant barriers to PrEP engagement, highlighting the need for integrated approaches that combine HIV prevention with mental health support. In this 3-year R34 pilot study, we propose a Type 1 hybrid effectiveness–implementation randomized controlled trial to evaluate the acceptability, feasibility, appropriateness, and preliminary effects of integrating an evidence-based trauma-focused mental health intervention, Skills Training in Affect and Interpersonal Regulation (STAIR), into the existing PrEP Well implementation strategy. In parallel, we will assess implementation processes and address barriers using a multilevel implementation framework. This study will be among the first to embed an evidence-based mental health intervention within a community-led PrEP implementation program, with the goal of enhancing PrEP uptake and persistence while simultaneously addressing broader needs such as housing, employment, and legal services for priority populations in Los Angeles County.
