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

September 27, 2021 updated by: Duke University

Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: P3-T PrEP Adherence App
P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.
Other Names:
  • P3-T
No Intervention: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Chulalongkorn University
Thai Red Cross AIDS Research Centre
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Sara LeGrand, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0099 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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