UCSD: PrEP Linkage Adherence & Pharmacology in Transgender Persons

With the introduction of pre-exposure prophylaxis (PrEP) for HIV it is even more evident how transgender persons have been largely under served for HIV prevention. Experience with PrEP in transgender persons is generally lacking for how individuals will be engaged in care and whether they will be take their medication regularly. Fundamental questions about the how these drugs may interact with hormonal treatment are still outstanding. In this proposal, we developed scientific aims that were developed through community consultation to study PrEP in transgender persons. Based on these efforts we will examine methods to facilitate linkage into PrEP treatment and ways to assist in remembering to take medication, specifically designed for transgender women and men. Concern over drug interactions with hormone therapy was a common theme in our meetings with the community resulting in an aim to determine if there is any interaction of PrEP medication (tenofovir (TDF) and emtricitibine (FTC)) with hormonal therapy. Our study will enroll 300 transgender women and men who need HIV prevention to receive TDF/FTC for 48 weeks at five study sites as part of the California Collaborative Treatment Group (CCTG) that combine three academic centers (UCSD, Harbor-UCLA and USC) with the largest providers of transgender services in Los Angeles (The Lesbian, Gay, Bisexual and Transgender Center) and San Diego (Family Health Centers). Combined our sites have already provided PrEP in demonstration projects to over 600 individuals. For linkage improvement we will test if a transgender focused case management approach to contextualize PrEP within the needs of the whole person can improve PrEP linkage and engagement. For medication adherence we will use an already developed text messaging reminder system and test if added real-time counseling at times of missed doses will improve overall success in taking regular dosing over the course of study. We will use the daily reporting of doses taken by text messaging to confirm whether the same drug levels expected to be protective for HIV are achieved by transgender women on hormonal therapy and if taking TDF/FTC is associated with any changes in hormone levels. We expect these aims to deliver implementable real world solutions for PrEP delivery. Combined the aims of this proposal will provide the scientific rigor needed to support clinical guidelines on PrEP use in transgender persons.