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 gay, bisexual, and other 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" was designed to adapt and test a theory-based, PrEP adherence smartphone app, P3, to 1) improve PrEP adherence and thus protective PrEP drug levels, 2) to increase retention in PrEP clinical care, 3) support PrEP persistence among YMSM in the United States for YMSM in Thailand, and 4) conduct 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 was 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 were goal-oriented and immersive and provided a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention and avoiding boredom and attrition.

The pilot RCT of the adapted P3-T app was conducted with 60 YMSM newly starting PrEP in Bangkok, Thailand to 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence.

In-depth interviews were 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Not provided

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

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 Number of Days of Any App Use	Month 3	The number of days of any app use among those assigned to the P3-T adherence arm during the 3-month intervention period as recorded by backend app metrics. Higher number of days indicates higher intervention feasibility.
Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App	Month 3	The number of days of PrEP medication tracked through app during the 3-month intervention period among participants assigned to the P3-T adherence arm as recorded by backend app metrics. Higher number indicates higher intervention feasibility.
Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8	Month 3	Intervention acceptability was assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction, collected in the 3-month follow-up survey (intervention group only). The eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, the effectiveness of app for dealing with health issue (PrEP adherence), overall satisfaction, and willingness to use the app again) were assessed using a 4-point response scale with individually specified anchors. The mean composite score of the CSQ-8 was calculated with a total possible range of 8 (lowest acceptability, worst outcome) to 32 (highest acceptability, best outcome).

Secondary Outcome Measures

Name	Time	Method
Difference in PrEP Medication Adherence Between Study Arms at Month 3	Month 3	The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms.
Difference in PrEP Medication Adherence Between Study Arms at Month 6	Month 6	The number of participants with protective levels of TFV-DP at month 6 between the study arms.