CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 145 enrolled
Drug / intervention
Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP) +2 morebehavioral
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/NCT05262426
NCT05262426N/AActive

Optimizing an mHealth Intervention to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Vulnerable Adolescents and Emerging Adults

University of Massachusetts, Worcester·interventional·Posted Mar 2, 2022·Updated Mar 13, 2026

In Brief

A clinical study evaluating Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool, and 1 other intervention for Pre-Exposure Prophylaxis. Active but no longer recruiting, targeting 145 participants across 3 sites.

Detailed Summary

The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.

Study Details

Timeline

N/AActive
20222023202420252026
First PostedMar 2, 2022
Enrollment StartDec 27, 2021
Primary CompletionJan 31, 2026
Study CompletionJul 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 4.3 years ago

Interventions

Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)behavioral

MES-PrEP is a two-session computer-delivered intervention based on IMB model. The intervention is tailored based on the person's ratings of perceived importance and confidence of initiating PrEP and sustaining adherence to PrEP. Participants are routed to different intervention content based on their assessment of their importance and confidence. Youth are provided with feedback on scores on the knowledge assessment followed by information about protective effect that can result from improved PrEP adherence. Finally, participants are asked to set a goal: obtain PrEP prescription, optimal adherence, practice steps, or thinking about it more, and they form plans for overcoming barriers. In the second session, branches are based on whether the youth felt they met the goal, partially met the goal, or did not meet the goal. Sessions of MES-PrEP will occur at baseline and month 1.

Enhanced YaCoolbehavioral

Enhanced YaCool is mobile application developed to support transgender women self-management of their gender and sexual health, including PrEP use. YaCool is a passcode-protected app that allows users to personalized text messaged reminders to take PrEP and/or clinic appointments, record PrEP adherence and sexual activity, and track lab tests. The application is set up to provide personalized recommendations for PrEP regimen, confirmed by clinic healthcare staff. Participants will be asked to download Enhanced YaCool to support PrEP use and gender/sexual health self-management between MES-PrEP sessions for 30 days, and thereafter until the end of Month 12 (if desired).

Standard PrEP Counselingbehavioral

All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3, 6, 9 and 12. Standard PrEP counseling includes sexual and behavioral risk assessment for HIV/STIs and risk reduction. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP/post-exposure prophylaxis (PEP) and facilitators and barriers of accessing PrEP. For those on PrEP, the sessions will focus on adherence. Standard counseling sessions will be nonjudgmental, non-discriminatory and client-centered.