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PrEP Adherence Enhancement Guided by iTAB and Drug Levels for Women (AEGiS)

Status
Planned
Phase
Demo Project
Principal Investigator(s)
Raphael Landovitz, MD
Objective

The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when taken daily)

Prevention Option(s)
PrEP
Study Design
Open label
Arms and Assigned Interventions
Description
ing/Counseling 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. Other Name: iTAB Behavioral: Text Messaging/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. Other Names: Integrate Next Step Counseling (iNSC) Targeted iNSC PrEP Steps
Products
TDF
ARMs
Experimental
Trial Sponsors
California HIV/AIDS Research Program of the University of California; Gilead Sciences
Product Developers
California Collaborative Treatment Group; University of California, San Diego; UCLA; University of Southern California; City of Long Beach Department of Health and Human Services
January 2016
January 2018
Enrollment
100
18
Years
Population
Women
Sites

UCSD Antiviral Research Center

San Diego, California
United States of America

Los Angeles Biomedical Research Institute at Harbor-UCLA

Los Angeles, California
United States of America

USC 5P21 Rand Schrader Clinic

Los Angeles, California
United States of America

APLA Health & Wellness' Gleicher / Chen Health Center

Los Angeles, California
United States of America