Clinical Trial

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

Study acronym: TAF4TRANS

Active, Not Recruiting Phase 4

Record status

This record was last updated May 6, 2023 (before its estimated January 31, 2024 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2020-11-03; most recent amendment 2024-07-29.

Status change: Completed → Active, Not Recruiting 2023-05-02

Status change: Active, Not Recruiting → Completed 2022-09-21

Status change: Recruiting → Active, Not Recruiting 2022-01-24

Trial Details

NCT Number	NCT04616963
Lead Sponsor	University of California, San Diego
Conditions	Hiv, Hormone Therapy
Enrollment	64 participants
Start Date	2019-10-24
Primary Completion	2024-01-31 (estimated)
Study Completion	2024-01-31 (estimated)
Updated on ClinicalTrials.gov	2023-05-06