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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 24, 2019

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2024

Conditions
HivHormone Therapy
Interventions
DRUG

Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg

Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.

DRUG

Emtricitabine Tenofovir Alafenamide 200/25 mg

Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation

Trial Locations (1)

92103

UC San Diego AntiViral Research Center (AVRC), San Diego

All Listed Sponsors
lead

University of California, San Diego

OTHER