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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Pre-Exposure Prophylaxis

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


Participation Criteria
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Eligibility Criteria
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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: 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). 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-arm RCT with 2:1 randomization to MES-PrEP+MTM or standard PrEP Counseling
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Knowledge | 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 | 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 | 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 | 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 | 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 | HIV status based on 4th generation HIV-1/2 antigen/antibody combo testing. | Baseline to Month 6 | 
| Sexually Transmitted Infections (STIs) Diagnosis | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth)