Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM (JomPrEP)

July 23, 2025 updated by: Roman Shrestha, University of Connecticut
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

mHealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations, like MSM, and link them to care. Leveraging mHealth reduces individuals' discomfort and distrust of disclosing risk behaviors to providers, providers' low cultural competency for working with individuals of diverse sexual identities, and bypasses barriers to health care for marginalized populations, - all features crucial for HIV prevention in MSM in Malaysia. It can further guide prevention delivery and health decision-making in a confidential, less stigmatizing, and convenient manner.

Results from our studies show Malaysian MSM often do not get HIV tested, initiate PrEP, or have their mental health needs addressed. Mixed methods suggest MSM want these services but prefer a streamlined system to access them that reduces interaction with clinicians where disclosure and perceived judgment occurs. mHealth may overcome these barriers by doing the screening confidentially and result in an "eligibility" output that automates HIV prevention service delivery (e.g., HIV testing, pre-exposure prophylaxis; PrEP). Overall smartphone growth in Malaysia (63% in 2015 to 89% in 2017) and our parallel work with MSM indicates that nearly all (>97%) MSM own a smartphone; Internet penetration is 89.4%, mostly through smartphones. Findings from our qualitative interviews with MSM further indicate stated preferences for interfacing with 'apps' rather than health professionals to access HIV testing, PrEP, counseling, and sexual health services as well as stakeholders indicating strong interest in using app-based platforms to deliver integrated care (e.g., HIV, mental health) align with developing culturally tailored mHealth strategies and to engage MSM in virtual communication with providers about their unmet needs for HIV testing, PrEP, and mental and sexual needs - all embedded within one app. The cross-cutting prevention strategies like the use of mHealth, particularly smartphone apps, thus hold great promise for HIV prevention in Malaysian MSM, especially when linked to HIV testing, PrEP, and co-morbid P/SUD screening and feedback, which will likely facilitate adherence and reduce HIV risk.

Although mHealth has been widely applied and efficacious in promoting health outcomes in multiple patient populations and contexts, app-based platforms to improve the HIV prevention cascade are just emerging. Few apps specifically to increase uptake and adherence to PrEP are evolving and limited to high-income countries. Further, these apps do not address mental health issues that are common in those who need HIV prevention most.

Given the evolving HIV epidemic among men who have sex with men (MSM) in Malaysia and their challenges with accessing prevention services, we previously proposed to adapt, expand, and refine an existing app (namely the HealthMindr app) to deliver an integrated HIV prevention intervention that will promote HIV testing and linkage to pre-exposure prophylaxis (PrEP) and that incorporates screening and support for psychiatric and substance use disorder (P/SUD) for Malaysian MSM. We have previously developed a new app (called JomPrEP) designed to improve access to HIV prevention services (i.e., HIV testing and PrEP) among Malaysian MSM. We now plan to conduct a Type 1 Hybrid Implementation Science Trial to (1) evaluate the efficacy of the JomPrEP app vs. treatment as usual (TAU) in Malaysian MSM (using a randomized controlled trial) and (2) assess contextual implementation factors (using focus groups).

Study Type

Interventional

Enrollment (Actual)

268

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

  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya
      • Kuala Lumpur, Malaysia
        • CERiA

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JomPrEP App Group
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
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.
Active Comparator: Treatment as usual
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HIV testing
Time Frame: 3, 6, and 9 months post-randomization
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
Time Frame: 3, 6, and 9 months post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PrEP adherence
Time Frame: 3, 6, and 9 months post-randomization
PrEP Adherence will be assessed using Dried Blood Spots at 3-, 6-, and 9-month follow-ups, which will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC.TFV-DP ≥700 fmol/punch will be defined as optimal adherence.
3, 6, and 9 months post-randomization

Collaborators and Investigators

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

Sponsor

University of Connecticut

Collaborators

Yale University
National Institutes of Health (NIH)
University of Malaya

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)

April 11, 2023

Primary Completion (Actual)

July 12, 2025

Study Completion (Actual)

July 12, 2025

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 23, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R33TW011665 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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