CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 136 enrolled
Drug / intervention
Daily Oral PrEP +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02584140
NCT02584140Phase 4Completed
CompareCT.gov

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

University of California, Los Angeles·interventional·Posted Oct 22, 2015·Updated Jul 8, 2021

In Brief

A Phase 4 clinical trial evaluating Text Messaging, Adherence Counseling, and 1 other intervention for HIV Prevention. Completed, enrolled 136 participants across 5 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesUnited States
CollaboratorsUniversity of California, San Diego, California HIV/AIDS Research Program, Los Angeles County Department of Public Health, AIDS Project Los Angeles

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2015
Enrollment StartMay 1, 2016
Primary CompletionMay 15, 2019
Study CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.7 years ago

Interventions

Text Messagingbehavioral

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.

Adherence Counselingbehavioral

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.

Daily Oral PrEPdrug

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