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

May 2, 2023 updated by: Bo Wang, University of Massachusetts, Worcester

Adapting Effective mHealth Interventions to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Thai Young Men Who Have Sex With Men (MSM).

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Institute of HIV Research and Innovation
        • Contact:
      • Bangkok, Thailand, 10240
        • Recruiting
        • Rainbow Sky Association of Thailand
      • Bangkok, Thailand, 10500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard PrEP Counseling
Participants in this arm will receive the standard PrEP counseling.
Behavioral: Standard PrEP Counseling
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.
Experimental: MES-PrEP and MTM
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)
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: Motivational Interactive Text Messaging (MTM)
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.
Behavioral: Standard PrEP Counseling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability: System Usability Score
Time Frame: Month 3
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
Time Frame: 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.
Month 6
Intervention Acceptability: Client Satisfaction Questionnaire
Time Frame: Month 3
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
Time Frame: 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.
Month 6
Intervention Feasibility: Number of responses to text messages
Time Frame: 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.
Baseline through Month 6
Intervention Feasibility: Number of intervention sessions completed
Time Frame: 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.
Baseline through Month 6
Intervention Feasibility: Participant retention
Time Frame: Baseline through Month 6
Intervention Feasibility will be measured by participants retention rate at Month 6.
Baseline through Month 6
PrEP Adherence: Visual analog scale
Time Frame: 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.
Baseline through Month 6
PrEP Adherence: Self-reported adherence
Time Frame: Baseline through Month 6
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
Time Frame: 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.
Baseline through Month 6
PrEP uptake
Time Frame: 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.
Month 1 through Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Knowledge
Time Frame: 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.
Baseline to Month 6
HIV Knowledge
Time Frame: 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.
Baseline to Month 6
Motivation: Rollnick's Readiness Ruler
Time Frame: 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.
Baseline to Month 6
Motivation: Decisional Balance for PrEP Use
Time Frame: 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.
Baseline to Month 6
Behavioral Skill
Time Frame: 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.
Baseline to Month 6
HIV Status
Time Frame: Baseline to Month 6
HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing.
Baseline to Month 6
Sexually Transmitted Infections (STIs) Diagnosis
Time Frame: 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.
Baseline to Month 6
Sexual Risk
Time Frame: 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.
Baseline to Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health
Time Frame: Baseline to Month 6
Mental Health will be assessed using the 12-item Thai General Health Questionnaire. The 4-point Likert scale measures psychological distress such as depression, anxiety, social impartment and somatic complaints. All items are rated on a 4-point Likert scale. The total possible score is 48, with higher scores indicating higher severity of psychological distress.
Baseline to Month 6
PrEP-related Stigma
Time Frame: Baseline to Month 6
PrEP-related stigma will be assessed using the 10-item PrEP stigma and positive attitudes scale. The 5-point Likert scale measures opinions about PrEP.
Baseline to Month 6
Social support
Time Frame: Baseline to Month 6
Social support will be assessed using the 13-item Social Provision Scale (SPS). The 5-point Likert scale measures the availability of social support, including emotional support, information support, instrumental support, companionship and social isolation. The total possible score is 65, with higher scores indicating greater availability of social support.
Baseline to Month 6
Perceived HIV risk
Time Frame: Baseline to Month 6
Perceived HIV risk will be measured using the 8-item Perceived Risk of HIV Scale. Higher scores indicating higher perceived risk for HIV.
Baseline to Month 6
Drug/Alcohol Use: ASSIST
Time Frame: Baseline to Month 6
Drug/Alcohol Use will be assessed using Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization (WHO). ASSIST is a questionnaire that is used for identification of substance use related health risks and substance use disorders. Each item ranges from 0-12, with 0 reflecting low risk score. The total possible score is 24, with higher number indicating higher risk of health and other problems based from the current pattern of substance use.
Baseline to Month 6
Drug/Alcohol Use: AUDIT-C
Time Frame: Baseline to Month 6
Alcohol Use Disorders Identification Test (AUDIT-C) or a brief alcohol screening instrument will also be used to identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). Each item ranges from 0 to 4, with 0 reflecting no alcohol use. The total possible score is 12, with higher number indicating higher drink above recommended limits and are at increased risks for harm.
Baseline to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Mental Health (NIMH)
Wayne State University
Institute of HIV Research and Innovation Foundation, Thailand

Investigators

  • Principal Investigator: Bo Wang, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H00023523
  • 1R34MH124081-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected during the study, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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