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

NCT05243030 | Completed DMC

• 2 other identifiers: H000235231R34MH124081-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 3

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).

Conditions

Pre-Exposure Prophylaxis

Keywords

Pre-exposure Prophylaxis (PrEP); HIV Prevention; Mobile health (mHealth)

Outcome Measures

Primary Outcomes (11)

• Intervention Acceptability: System Usability Score

  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.

  Month 3

• Intervention Acceptability: System Usability Score

  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.

  Month 6

• Intervention Acceptability: Client Satisfaction Questionnaire

  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.

  Month 3

• Intervention Acceptability: Client Satisfaction Questionnaire

  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.

  Month 6

• Intervention Feasibility: Number of responses to text messages

  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.

  Baseline through Month 6

• Intervention Feasibility: Number of intervention sessions completed

  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.

  Baseline through Month 6

• Intervention Feasibility: Participant retention

  Intervention Feasibility will be measured by participants retention rate at Month 6.

  Baseline through Month 6

• PrEP Adherence: Visual analog scale

  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.

  Baseline through Month 6

• PrEP Adherence: Self-reported adherence

  PrEP adherence will be measured from self-reported adherence to PrEP in the past 4 weeks.

  Baseline through Month 6

• PrEP Adherence: Dried blood spots

  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.

  Baseline through Month 6

• PrEP uptake

  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.

  Month 1 through Month 6

Secondary Outcomes (8)

• PrEP Knowledge

  Baseline to Month 6

• HIV Knowledge

  Baseline to Month 6

• Motivation: Rollnick's Readiness Ruler

  Baseline to Month 6

• Motivation: Decisional Balance for PrEP Use

  Baseline to Month 6

• Behavioral Skill

  Baseline to Month 6

Other Outcomes (6)

• Mental Health

  Baseline to Month 6

• PrEP-related Stigma

  Baseline to Month 6

• Social support

  Baseline to Month 6

Study Arms (2)

MES-PrEP and MTM

EXPERIMENTAL

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

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

Standard PrEP Counseling

ACTIVE COMPARATOR

Participants in this arm will receive the standard PrEP counseling.

Behavioral: Standard PrEP Counseling

Interventions

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

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.

MES-PrEP and MTM

Motivational Interactive Text Messaging (MTM) BEHAVIORAL

Participants will receive automated motivational text messages to promote PrEP initiation and adherence. These contents will be customized based on their readiness to change in regards to PrEP. The message content is individualized based on participant response to baseline survey. Those participants who indicate that they are "ready" to set the goal to take PrEP will receive text messages reminding them to take PrEP. Those who indicate that they are less than ready to take their PrEP can choose from a range of alternatives, such as taking on-demand PrEP or just think about taking PrEP. For those who are not ready to take PrEP, the content will be individualized based on the participant's choice, i.e., a daily message encouraging them to work toward their chosen goal. Participants who are currently not on PrEP will receive daily text messages regarding PrEP effectiveness, HIV risk and where to access PrEP.

MES-PrEP and MTM

Standard PrEP Counseling BEHAVIORAL

All participants will received one-on-one, face to face counseling from lay providers at baseline, months 1, 3 and 6. 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.

MES-PrEP and MTM; Standard PrEP Counseling

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Men who have sex with men
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• having a sex with an HIV-positive partner
• having anal sex
• without using a condom
• being diagnosed with an STI or
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of HIV Research and Innovation Foundation, Thailand: collaborator
• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator
• Wayne State University: collaborator

Study Sites (3)

Rainbow Sky Association of Thailand

Bangkok, Bangkok, 10240, Thailand

Location

Institute of HIV Research and Innovation

Bangkok, Bangkok, 10330, Thailand

Location

SWING Foundation

Bangkok, Bangkok, 10500, Thailand

Location

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Study Officials

• Bo Wang, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-arm RCT with 2:1 randomization to MES-PrEP+MTM or standard PrEP Counseling

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 16, 2022
• Study Start: February 23, 2022
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

TH (3)