Clinical trial NCT04413708: mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
Official title: Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Pre-Exposure Prophylaxis
HIV/AIDS
Keywords: PrEP adherence
HIV
Young men who have sex with men
YMSM
Thailand
Mobile app
mHealth
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Chulalongkorn University
name: Thai Red Cross AIDS Research Centre
name: Fogarty International Center of the National Institute of Health
First posted: 2020-06-04
Enrollment: 60
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Intervention Feasibility: Average Number of Days of Any App Use
timeFrame: Month 3
measure: Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App
timeFrame: Month 3
measure: Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8
timeFrame: Month 3
Secondary outcomes:
measure: Difference in PrEP Medication Adherence Between Study Arms at Month 3
timeFrame: Month 3
measure: Difference in PrEP Medication Adherence Between Study Arms at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Duke University
name: Sara LeGrand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Songtaweesin WN, LeGrand S, Bandara S, Piccone C, Wongharn P, Moonwong J, Jupimai T, Saisaengjan C, Theerawit T, Muessig K, Hightow-Weidman L, Puthanakit T, Phanuphak N, Tangmunkongvorakul A. Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study. J Med Internet Res. 2021 Nov 4;23(11):e23852. doi: 10.2196/23852.