NCT03652623View on ClinicalTrials.gov

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

July 23, 2018

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
HIV/AIDSGenderBehavior and Behavior Mechanisms
Interventions
DRUG

TDF/FTC

In Phase 1, a PK study will be conducted to evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among transgender women taking estradiol and transgender men taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily TDF/FTC adherence and maximize drug exposure.

Trial Locations (1)

80045

University of Colorado, Denver, Aurora

Sponsors
All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Hektoen Institute for Medical Research

OTHER