mHealth Technologies to Enhance PrEP Adherence Among Thai MSM

NCT04413708 | Completed Results

• 2 other identifiers: 2020-00991R21TW010965
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PrEP adherence; HIV; Young men who have sex with men; YMSM; Thailand; Mobile app; mHealth

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility: Average Number of Days of Any App Use

  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.

  Month 3

• Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App

  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.

  Month 3

• Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8

  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).

  Month 3

Secondary Outcomes (2)

• Difference in PrEP Medication Adherence Between Study Arms at Month 3

  Month 3

• Difference in PrEP Medication Adherence Between Study Arms at Month 6

  Month 6

Study Arms (2)

P3-T PrEP adherence app

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

P3-T PrEP Adherence App BEHAVIORAL

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.

Also known as: P3-T

P3-T PrEP adherence app

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: Self-identify as male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator
• Chulalongkorn University: collaborator
• Thai Red Cross AIDS Research Centre: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 34734828 DERIVED

MeSH Terms

Conditions

Patient Compliance; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Sara LeGrand
• Organization: Duke University

sara.legrand@duke.edu

919-438-0448

Study Officials

• Sara LeGrand, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Model Description Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 12, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)