mHealth Technologies to Enhance PrEP Adherence Among Thai MSM (P3-T)

Duke University

Status: Completed

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

Treatments: Behavioral: P3-T PrEP Adherence App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04413708

2020-0099

1R21TW010965 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

P3-T PrEP adherence app

Experimental group

Description:

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.

Treatment:

Behavioral: P3-T PrEP Adherence App

Standard of Care

No Intervention group

Description:

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.