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

Study acronym: TAF4TRANS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary and study completion dates: Jun 30, 2022 to Jan 31, 2024 Trial status: Completed to Active, Not Recruitingv6 Show 1 more changeShow less
    • Trial status: Completed to Active, Not Recruiting
  2. Trial status: Active, Not Recruiting to Completedv5
  3. Primary and study completion dates: Dec 31, 2023 to Jun 30, 2022v4
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 64 · Site details revisedv3 Show 2 more changesShow less
    • Enrollment target: estimated 60 to confirmed 64
    • Site details revised
  5. Secondary endpoints: details revised at 1 of 5 entriesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04616963
Lead Sponsor University of California, San Diego
Conditions Hiv, Hormone Therapy
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov