Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04413708 |
| Other study ID # |
2020-0099 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2020 |
| Est. completion date |
August 10, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
