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

Not Applicable

Recruiting

• Conditions: Pre-Exposure Prophylaxis
• Interventions: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP); Behavioral: Standard PrEP Counseling; Behavioral: Motivational Interactive Text Messaging (MTM)

• Registration Number: NCT05243030
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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).

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). 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.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Study Start: 2022-02-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MES-PrEP and MTM	Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)	Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.
MES-PrEP and MTM	Motivational Interactive Text Messaging (MTM)	Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.
Standard PrEP Counseling	Standard PrEP Counseling	Participants in this arm will receive the standard PrEP counseling.
MES-PrEP and MTM	Standard PrEP Counseling	Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability: System Usability Score	Month 6	System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable.
Intervention Acceptability: Client Satisfaction Questionnaire	Month 6	Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability.
Intervention Feasibility: Number of responses to text messages	Baseline through Month 6	Intervention feasibility will be measured by total number of responses to text messages. Point estimates of \>50% of participants responded to at least one text message is considered as the minimum criteria for feasibility.
Intervention Feasibility: Number of intervention sessions completed	Baseline through Month 6	Intervention feasibility will be measured by number of intervention sessions completed. Point estimates of \>50% of participants completed at least one intervention session is considered as the minimum criteria for feasibility.
Intervention Feasibility: Participant retention	Baseline through Month 6	Intervention Feasibility will be measured by participants retention rate at Month 6.
PrEP Adherence: Visual analog scale	Baseline through Month 6	PrEP adherence will be measured from Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey which contains a visual analog scale (VAS). VAS ranges from 0 to 100, with higher percentage indicating greater adherence to PrEP.
PrEP Adherence: Self-reported adherence	Baseline through Month 6	PrEP adherence will be measured from self-reported adherence to PrEP in the past 4 weeks.
PrEP uptake	Month 1 through Month 6	PrEP uptake will be measured by the number of PrEP prescription, using a self-report measure (participants reporting if they left the clinic with PrEP) and confirming with clinic records.
PrEP Adherence: Dried blood spots	Baseline through Month 6	PrEP adherence will be measured by the level of tenofovir in dried blood spots (DBS). DBS report on 80% Truvada adherence after at least three weeks of regular adherence.

Secondary Outcome Measures

Name	Time	Method
PrEP Knowledge	Baseline to Month 6	Knowledge of PrEP will be measured using the 13-item PrEP knowledge scale. The total possible score is 13, with higher scores indicating a greater degree of PrEP knowledge.
HIV Knowledge	Baseline to Month 6	Knowledge of HIV transmission risk will be assessed using am 18-item HIV Knowledge Questionnaire. The total possible composite score range from 0 to 18, with higher scores indicating a greater degree of HIV knowledge.
Motivation: Rollnick's Readiness Ruler	Baseline to Month 6	Behavioral intentions will be measured using 5-item Rollnick's Readiness Ruler, which correspond to PrEP uptake and adherence. Each item ranges from 0 to 10, with higher numbers indicate greater readiness for change.
HIV Status	Baseline to Month 6	HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing.
Sexually Transmitted Infections (STIs) Diagnosis	Baseline to Month 6	STI diagnosis based on treponemal test with rapid plasma reagin (RPR) confirmation for syphilis. Pooled urine, oropharyngeal and rectal swabs for gonorrhea and chlamydia nucleic acid amplification test (NAAT) testing.
Sexual Risk	Baseline to Month 6	Sexual risk will be assessed through Timeline Followback via CASI, which collects sexual behavior in the past 30 days, including questions about condom use and number of sexual partners.
Motivation: Decisional Balance for PrEP Use	Baseline to Month 6	Attitude towards PrEP will be measured using 36-item Decisional Balance for PrEP Use. The 5-point Likert scale assesses the pros and cons of PrEP use and is helpful in understanding cognitive and motivational aspects of decision making.
Behavioral Skill	Baseline to Month 6	Behavior skills will be assessed using the 8-item adapted version of Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. The 5-point Likert scale assesses the confidence in using a condom, taking PrEP as recommended and getting PrEP refills. The total possible score is 40, with higher scores indicating a greater confidence for each item.

Trial Locations

Locations (3)

Rainbow Sky Association of Thailand; 🇹🇭 Bangkok, Thailand

Institute of HIV Research and Innovation; 🇹🇭 Bangkok, Thailand

SWING Foundation; 🇹🇭 Bangkok, Thailand