PROJECT ABSTRACT HIV prevalence is high among transgender and gender-diverse/expansive (TGD) individuals in the Ending the HIV Epidemic (EHE) priority jurisdiction of Los Angeles County (LAC). HIV pre-exposure prophylaxis (PrEP) is an evidence- based innovation and part of both the local LAC HIV Prevention Plan and the EHE ‘Prevent’ pillar for individuals with elevated risk for HIV exposure, such as TGD. However, uptake of PrEP remains low among TGNB individuals in LAC, especially among TGD individuals of color. Low uptake and persistence have been due to multiple structural and syndemic barriers such as unstable housing, financial hardship, violence exposure, and associated mental health burdens (e.g., depression, posttraumatic stress disorder [PTSD]) that have been previously identified in multiple studies as well as by our team in LAC. Currently, there is a high need to identify and test multilevel implementation strategies to improve and accelerate PrEP uptake and persistence among TGD individuals. Our uniquely qualified community-academic collaborative research team will leverage the parent study PrEP Well, a multiyear California HIV/AIDS Research Program-funded implementation science project (CHRP: H21IS3484), to bring comprehensive and gender-affirming PrEP services to scale in a first-of-its-kind transgender community center in LAC. Preliminary findings from the PrEP Well project indicate that that mental health burdens resulting from violence, trauma, and minority stressors, remain a significant barrier and that additional implementation strategies are currently needed for the successful integration of an evidence-based mental health intervention, Skills Training in Affect and Interpersonal Regulation (STAIR), within the PrEP Well implementation strategy. In the current 3-year pilot R34 study, we propose a Type 1: hybrid effectiveness-implementation pilot randomized controlled trial to assess the acceptability, feasibility, appropriateness, and preliminary effects of integrating a trans-affirming, evidence-based mental health treatment for persons who have experienced multiple prior traumas. Simultaneously, we will assess the implementation process and address implementation barriers through a multilevel implementation framework. This study will be among the first to integrate an evidence-based mental health intervention into an existing PrEP implementation project that has shown promising effects in increasing PrEP uptake and persistence while simultaneously addressing the structural needs (e.g., housing, legal, employment) of the local TGD community.

PROJECT NARRATIVE HIV pre-exposure prophylaxis (PrEP) is an evidence-based innovation and part of the EHE ‘Prevent’ pillar for individuals with an elevated risk for HIV exposure such as transgender and gender diverse/expansive (TGD) individuals, but uptake of PrEP remains low, especially among TGD individuals affected by violence and trauma. Currently, there is high need to identify and test multilevel implementation strategies that improve mental health and address structural barriers to improve and accelerate PrEP uptake and persistence among TGD individuals. Our uniquely qualified community-academic collaborative research team proposes to assess the acceptability, feasibility, appropriateness, and preliminary effects of integrating an evidence-based mental health treatment into an ongoing gender-affirming PrEP implementation project for TGD community members affected by violence, trauma, and HIV.