mHealth Technologies to Enhance PrEP Adherence Among Thai MSM

Not Applicable

Completed

• Conditions: Pre-Exposure Prophylaxis; HIV/AIDS; Adherence, Patient
• Interventions: Behavioral: P3-T PrEP Adherence App

• Registration Number: NCT04413708
• Lead Sponsor: Duke University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2020-06-12
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P3-T PrEP adherence app	P3-T PrEP Adherence App	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.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Average proportion of days of any app use	3 Months	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.
Intervention Acceptability: Mean intervention acceptability, composite score CSQ-8	Month 3	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).
Intervention Feasibility: Average proportion of days of PrEP medication tracked	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Difference in PrEP medication adherence between study arms at Month 6	Month 6	Comparison of the proportion of participants with protective levels of TFV-DP/FTC-TP at month 6 between the study arms.
Difference in PrEP medication adherence between study arms at Month 3	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.

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand