Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women

PHASE4CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

May 15, 2019

Study Completion Date

June 14, 2019

Conditions
HIV Prevention
Interventions
BEHAVIORAL

Text Messaging

All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.

BEHAVIORAL

Adherence Counseling

All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of \<1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of \<1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.

DRUG

Daily Oral PrEP

All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.

Trial Locations (5)

90016

APLA Health & Wellness' Gleicher / Chen Health Center, Los Angeles

90033

Los Angeles Biomedical Research Institute at Harbor-UCLA, Los Angeles

USC 5P21 Rand Schrader Clinic, Los Angeles

90062

T.H.E. at Ruth Temple, Los Angeles

92103

UCSD Antiviral Research Center, San Diego

All Listed Sponsors
collaborator

University of California, San Diego

OTHER

collaborator

California HIV/AIDS Research Program

OTHER

collaborator

Los Angeles County Department of Public Health

OTHER_GOV

collaborator

AIDS Project Los Angeles

OTHER

lead

University of California, Los Angeles

OTHER

NCT02584140 - Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women | Biotech Hunter | Biotech Hunter