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

Last updated: June 16, 2025
Sponsor: University of Massachusetts, Worcester
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Enhanced YaCool

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

Standard PrEP Counseling

Clinical Study ID

NCT05262426
H00023527
1R21HD107988-01
  • Ages 16-29
  • Male
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Aim 1:

Transgender women participants

Inclusion Criteria:

  • Age 16-29 years old

  • Male sex at birth

  • Self-identifies as woman or transgender women or culturally identifies with thefemale spectrum

  • Confirmed HIV-negative status

  • Self-reported recent history of condomless sex in the past 6 months

  • Able to understand, read and speak Thai

  • Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but notadherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users) orcurrently on PrEP with good adherence (Group 3: PrEP users with good adherence).

Exclusion

Exclusion Criteria:

  • Have a serious cognitive or psychiatric problem that would compromise ability toprovide informed consent

  • Have active suicidal ideation or major mental illness (e.g., untreated psychosis ormania) at the time of interview (patients will be referred for treatment)

  • Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreasedcreatinine clearance)

Healthcare providers

Inclusion Criteria:

  • Have at least 1-year experience working with HIV-negative transgender women,including providing PrEP prescription and counseling

Exclusion Criteria:

  • None

Aim 2:

Inclusion Criteria:

  • Age 16-29 years old

  • Male sex at birth

  • Self-identifies as woman or transgender women or culturally identifies with thefemale spectrum

  • Confirmed HIV-negative status

  • Self-reported recent history of condomless sex in the past 6 months

  • Able to understand, read and speak Thai

  • Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but notadherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Exclusion Criteria:

  • Have a serious cognitive or psychiatric problem that would compromise ability toprovide informed consent

  • Have active suicidal ideation or major mental illness (e.g., untreated psychosis ormania) at the time of interview (patients will be referred for treatment)

  • Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreasedcreatinine clearance)

  • Currently enrolled in another HIV intervention study

Study Design

Total Participants: 145
Treatment Group(s): 3
Primary Treatment: Enhanced YaCool
Phase:
Study Start date:
December 27, 2021
Estimated Completion Date:
March 21, 2025

Study 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.

Connect with a study center

  • Institute of HIV Research and Innovation

    Bangkok, 10330
    Thailand

    Site Not Available

  • Rainbow Sky Association of Thailand

    Bangkok, 10240
    Thailand

    Site Not Available

  • SWING Foundation

    Bangkok, 10500
    Thailand

    Site Not Available

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