mHealth Technologies to Enhance PrEP Adherence Among Thai MSM

Study Overview
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Brief Summary
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This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.

Detailed Description
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This R21 study, titled Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM: Collaborative Adaptation and Evaluation, is: 1) adapting the theory-based smartphone app, P3, designed to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence among YMSM in the United States for YMSM in Thailand, and 2) conducting a pilot RCT to assess the feasibility and acceptability of the adapted P3-T app and to examine the potential impact of the app on PrEP adherence. The study is a partnership between Duke University, Chulalongkorn University, Thai Red Cross AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC. P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social networking and game-based mechanics as well as evidenced-based features to improve PrEP medication adherence. P3 is a product born from the collaborative effort of researchers and health game developers working closely with members of the target population in the United States. Built on a successful, evidence-based platform designed by our collaborating technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for customization and adaptations for different cultural and linguistic contexts, and responsive to changes in technology. The social networking features of P3 are designed to capitalize on social involvement as a means through which YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Peers have been recognized as a highly important source of sexual health and HIV prevention information and support among Thai YMSM. The gaming features of P3 are goal-oriented and immersive and provide a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention, avoiding boredom and attrition. The pilot RCT of the adapted P3-T app with be conducted with 60 YMSM newly starting PrEP in Thailand to: 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence. The study will be 6 months in duration with a 3-month intervention period and include study visits at baseline, 3-months, and 6-months. At baseline, participants will complete a baseline web-based computer-assisted self-interviewing (CASI) survey. Next, participants will be randomized in a 1:1 ratio into the P3-T arm or standard of care (SOC) study arm. All study participants will complete follow-up CASI surveys and have their blood drawn via venipuncture at 3 and 6 months for collection of dried blood spots (DBS). In-depth interviews will be conducted with 10 P3-T arm participants after the 3-month intervention period. The interview will ask participants about their experience and impressions of the app, how they used it, and how it may have impacted their behaviors during the 3-month intervention period.

Official Title
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Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation

Conditions
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Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS

Intervention / Treatment
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* Behavioral: P3-T PrEP Adherence App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male sex at birth Gender identity is male Identify as a man who has sex with men Ages 16-24 Plan to start PrEP in next 14 days Able to speak and read Thai Own an Android or iOS smartphone Exclusion Criteria: Currently participating in another experimental PrEP adherence intervention Plan to move out of Bangkok in the next 6 months Unable to be consented due to an active substance use or psychological condition

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P3-T PrEP adherence app<br>Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period. Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. | Behavioral: P3-T PrEP Adherence App<br>* P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a bank account that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.<br>* Other names: P3-T;|
| No Intervention: Standard of Care<br>Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility: Average proportion of days of any app use | The average proportion of days of any app use during the trial across all participants as recorded by backend app metrics. Total possible range: 0-1. Higher proportion indicates higher intervention feasibility. | 3 Months | 
| Intervention Feasibility: Average proportion of days of PrEP medication tracked | The average proportion of days participants used the app to track PrEP medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | Month 3 | 
| Intervention Acceptability: Mean intervention acceptability, composite score CSQ-8 | The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome). | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in PrEP medication adherence between study arms at Month 3 | Comparison of the proportion of participants with protective levels of tenofovir-diphosphate (TFV-DP)/emtricitabine triphosphate (FTC-TP) at month 3 between the study arms. | Month 3 | 
| Difference in PrEP medication adherence between study arms at Month 6 | Comparison of the proportion of participants with protective levels of TFV-DP/FTC-TP at month 6 between the study arms. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, PrEP adherence, Young men who have sex with men, YMSM, Thailand, Mobile app, mHealth