Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men

University of Massachusetts, Worcester

Status: Completed

Conditions: Pre-Exposure Prophylaxis

Treatments: Behavioral: Motivational Interactive Text Messaging (MTM); Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP); Behavioral: Standard PrEP Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05243030

H00023523

1R34MH124081-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

Full 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). Motivational Interactive Text Messaging (MTM) will be integrated with MES-PrEP to provide ongoing support to maintain the individual's motivation for behavior change. Both interventions will be developed and refined based upon the inputs from YMSM through focus group discussion and youth advisory board.

The Investigators propose to pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention combining MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Eligible YMSM will be randomized to receive either the intervention plus the standard PrEP counseling or standard PrEP counseling, and followed for 6 months with assessments at baseline, month 1, 3 and 6.

Enrollment: 119 patients

Sex: Male

Ages: 16 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 16-25 years old

• Men who report sex with men in the past 12 months

• Confirmed HIV-negative status

• Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:

  1. having a sex with an HIV-positive partner
  2. having anal sex
  3. without using a condom
  4. being diagnosed with an STI or
  5. having any illicit drug use (e.g., Amphetamine type stimulants)

• Able to understand, read and speak Thai

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

Exclusion criteria

• In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
• Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
• currently enrolled in another HIV intervention study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

MES-PrEP and MTM

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.

Treatment:

Behavioral: Standard PrEP Counseling

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

Behavioral: Motivational Interactive Text Messaging (MTM)

Standard PrEP Counseling

Active Comparator group

Description:

Participants in this arm will receive the standard PrEP counseling.

Treatment:

Behavioral: Standard PrEP Counseling