NCT02584140

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an open-label single-arm longitudinal clinical trial to estimate medication adherence and retention in a PrEP HIV prevention program that implements a combination intervention strategy that uses text-messages (iTAB) and a staged adherence counseling support strategy titrated from real-time drug levels in women at-risk for HIV acquisition. A total of 135 participants will receive the combined intervention of text messaging adherence reminders and adherence support. The text messaging system consists of daily, personalized, automated 2-way text messages to maintain adherence and retention. Participants that have a low intracellular tenofovir diphosphate (TFV-DP) concentration will receive escalated, targeted adherence support. All participants will receive access to PrEP in accordance with standardized comprehensive methods of prescribing and clinical assessments that include safety monitoring as well as regular HIV and sexually transmitted infection (STI) screening. All participants will be followed for 48 weeks after enrollment and will receive a post study follow-up at 60 weeks. The primary endpoint will be measured at 48 weeks.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-05-15
• Completion: 2019-06-14
• First posted: 2015-10-22
• Last updated: 2021-07-08
• Results posted: 2020-05-27

Locations

5 sites across 1 country: United States