Active, not recruitingInterventionalPhase 4Last updated May 6, 2023

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

F/TAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis (TAF4TRANS)

Overview

ClinicalTrials.gov ID: NCT04616963
Lead Sponsor: University of California, San DiegoOTHER
Brief 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.

Status

Overall Status: Active, not recruiting
Start Date: Oct 24, 2019Actual
Primary Completion Date: Jan 31, 2024Estimated
Completion Date: Jan 31, 2024Estimated

Study Record Dates

First Submitted: Jul 13, 2020
First Submitted that Met QC Criteria: Nov 3, 2020
First Posted: Nov 5, 2020Actual
Last Update Submitted that Met QC Criteria: May 2, 2023
Last Update Posted: May 6, 2023Actual
Last Verified: May 2023

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