Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM

NCT05325476 | Completed

• 1 other identifier: R33TW011665
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 2

Brief Summary

This project will involve conducting a Type I Hybrid Implementation Science trial to assess the efficacy of the JomPrEP app while measuring contextual implementation factors to guide its future adoption and scale-up.

Conditions

HIV Prevention Program

Keywords

PrEP; mHealth; Smartphone app; mobile app; men who have sex with men

Outcome Measures

Primary Outcomes (2)

• Changes in HIV testing

  HIV testing dates will be assessed at each follow-up time point (3, 6, and 9 months) using self-report.

  3, 6, and 9 months post-randomization

• Changes in PrEP uptake

  PrEP uptake (current use of PrEP; yes/no) will be assessed at each follow-up time point (3, 6, and 9 months) using self-reported visual analogue scale. The higher the score on the scale the higher the PrEP uptake. Score (0-100).

  3, 6, and 9 months post-randomization

Secondary Outcomes (1)

• Changes in PrEP adherence

  3, 6, and 9 months post-randomization

Study Arms (2)

JomPrEP App Group

EXPERIMENTAL

Participants in the TAU group will receive the JomPrEP app with major intervention features inactivated; information and resources for HIV testing, PrEP, and available mental health and addiction services will be available along with access to risk assessment tools. The Research Assistant will assist in downloading the app and provide a tutorial in using the assessment tool of the app.

Other: JomPrEP App

Treatment as usual

ACTIVE COMPARATOR

Participants in the JomPrEP group will be provided with full app access. The Research Assistant will use an onboarding checklist to orient participants to download the app and its use. Participants will be encouraged to explore and use all components of the app. Participants will be able to personalize the frequency, timing, and content for daily adherence support and weekly behavioral feedback messages and receive reminders for regular PrEP care. Participants can also contact the Research Assistant using the chat function for support and assistance with linkage to services.

Other: Inactivated JomPrEP app

Interventions

JomPrEP App OTHER

The JomPreP app will be ideally designed to optimize HIV prevention cascade by providing a virtual platform to access to HIV prevention (e.g., HIV testing and PrEP) and other support services (e.g., mental health). The JomPrEP app will be available on the Apple Store and the Google Play Store for the users to download. However, access to the app will be restricted to the research participant using a unique registration code.

JomPrEP App Group

Inactivated JomPrEP app OTHER

Participants will have access to the JomPrEP app with major intervention features inactivated. Information and resources for HIV testing, PrEP, and available mental health and addiction services will be available along with access to risk assessment tools. The RA will assist in downloading the app and provide a tutorial in using the assessment tool of the app.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV negative or status unknown
• Cis-gender men who have sex with men
• Age more than or equal to 18 years
• Own a smartphone (Android or IOS)

You may not qualify if:

• Unable to read or understand English or Bahasa Malaysia
• Unable to provide informed consent

Sponsors & Collaborators

• University of Connecticut: lead
• University of Malaya: collaborator
• National Institutes of Health (NIH): collaborator
• Yale University: collaborator

Study Sites (2)

CERiA

Kuala Lumpur, Malaysia

Location

University of Malaya

Kuala Lumpur, Malaysia

Location

Related Publications (25)

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  PMID: 36542425 DERIVED

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 13, 2022
• Study Start: April 11, 2023
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

MY (2)