NCT05262426

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: Male
• Age: 16 Years – 29 Years
• Healthy volunteers: Accepted

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.

Detailed description

Motivational Enhancement System for Adherence (MESA) is a computer-based motivation invention, based on the Information-Motivation-Behavioral Skills (IMB) model and Motivational Interviewing (MI) principles, used to promote adherence among HIV-positive youth initiating antiretroviral treatment. In this study, the team will adapt and develop MESA to focus on PrEP uptake and adherence, which will be called Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). YaCool is a mobile application developed to support transgender women self-management of gender and sexual health, including PrEP use. In Aim 1, the investigators will begin with needs assessment to evaluate intervention efficacy by exploring the barriers and facilitators of PrEP uptake and adherence through in-depth interviews with transgender women and community health workers. The two interventions will be developed and refined based upon the inputs from transgender women through focus group discussion and community advisory board. In Aim 2, the investigators will conduct a Multiphase Optimization Strategy (MOST) design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool and to determine whether MES-PrEP works better when combined with Enhanced YaCool to improve PrEP use. Eligible transgender women will be randomized to one of the four experimental conditions, and followed for 12 months with assessments at baseline, month 1, 3, 6, 9 and 12.

Conditions

• Pre-Exposure Prophylaxis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-27
• Primary completion: 2026-01-31
• Completion: 2026-07-31
• First posted: 2022-03-02
• Last updated: 2026-03-13

Locations

3 sites across 1 country: Thailand