Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults

NCT05262426 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Pre-Exposure Prophylaxis

Interventions

BEHAVIORAL

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

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.

BEHAVIORAL

Enhanced YaCool

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).

BEHAVIORAL

Standard PrEP Counseling

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Wayne State University

    collaborator OTHER
  • Institute of HIV Research and Innovation Foundation, Thailand

    collaborator OTHER
  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Bo Wang · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2026-01-31
Completion
2026-07-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262426 on ClinicalTrials.gov