Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

Summary

The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

Timeline

Start

2019-10-24

Primary completion

2024-01-31

Completion

2024-01-31

Publications

• Patel N, Awdishu L, Burke LB, Vaingankar S, Chow K, Pacheco D, Silva J, Higgins N, Muttera L, Blumenthal J, Morris S. Comparison of Existing and New Race- and Sex-Free Kidney Function Equations in Transgender Adults without CKD. Clin J Am Soc Nephrol. 2025 Jul 22;20(9):1280-1282. doi: 10.2215/CJN.0000000688. No abstract available.

Drugs

Indications