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    La Clinica de la Raza: Layla Welborn

    Gender Health Center: Ben Hudson

    UCSF: Culturally Relevant PrEP Demonstration for Trans Communities

    Jae Sevelius, Principal Investigator (UCSF)

    The overall goal of the proposed TRIUMPH Project (Trans Research-Informed communities United in Mobilization for the Prevention of HIV) is to develop and evaluate a culturally-relevant, community-led PrEP demonstration project, driven by the needs and experiences of transgender women of color. We will identify optimal methods to deliver PrEP safely and effectively, and with the highest possible levels of adherence, to both transgender women and men, with an emphasis on transgender women of color. Because trans women in particular have unique facilitators and barriers to care and high levels of medical mistrust, it is imperative that our interventions be guided by evidence specific to transgender populations, rather than adaptations of interventions originally developed for men who have sex with men (MSM). The TRIUMPH uptake intervention consists of community-led mobilization efforts to increase knowledge and acceptability of PrEP, utilizing PrEP champions from within trans communities, and trans-specific PrEP educational materials, including trans-specific patient decision aids that will assist people in making informed choices about PrEP. Our adherence intervention consists of peer-led health workshops and one-on-one personalized adherence counseling sessions. The conceptual framework for TRIUMPH is grounded in the Model of Gender Affirmation, the only trans-specific framework examining risk behavior among trans women (developed by PI Sevelius), and all aspects of service provision strategies will be trauma-informed, to address the significant barriers that transgender people often encounter when deciding to access care.

    As part of this project, our primary aims are to: 

    1. Develop an efficient PrEP delivery system within a network of clinics and community-based organizations through programming designed specifically to serve transgender communities.
    2. Develop a culturally-relevant, adaptive intervention to increase PrEP uptake and support adherence among transgender communities.
    3. Determine the feasibility, acceptability, and effectiveness of PrEP implementation in real world settings for transgender communities.

    We will test how our methods affect people’s choices about whether or not to take PrEP (uptake), whether they take it as prescribed (adherence), whether PrEP works well for participants (effectiveness), and whether they continue to take PrEP for the duration of the study (persistence). Other outcomes we are interested in include: 1) Assess potential drug interactions between Truvada and gender affirming hormone therapy, 2) Evaluate dosage effects of adaptive adherence interventions, 3) Explore risk perception, PrEP uptake, and adherence among transgender men, 4) Assess self-reported strategic dosing, changes in sexual practices, and sexual satisfaction during PrEP use and 5) Examine the role of bundling of hormone therapy with PrEP on primary outcomes. At least 40% of the sample will be persons of color, and at least 20% African-American. Through quantitative and qualitative evaluation methods, we will enumerate predictors and indicators of uptake of and adherence to PrEP, how long it is used, and best methods to determine when and how to discontinue PrEP use among trans people. Our trans-informed research methods and clinical expertise with trans populations are critical to the successful development and implementation of an effective PrEP demonstration project with this unique and under-served population.