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HIV Prevention ProgramJomPrEPNCT05325476

Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM

A study testing JomPrEP App and Inactivated JomPrEP app in people with HIV Prevention Program, run by University of Connecticut at 2 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention Program
What is being tested?
JomPrEP App and Inactivated JomPrEP app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
2 sitesMalaysia
Study dates
11 Apr 2023to 12 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Malaysia2 sites
  • CERiA

    Kuala Lumpur

  • University of Malaya

    Kuala Lumpur

Other trials in Malaysia

About this study

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.

Read the 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).

Being tested
JomPrEP App, Inactivated JomPrEP app
Keywords
PrEP, mHealth, Smartphone app, mobile app, men who have sex with men
Medical subject headings
Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JomPrEP AppOther

    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.

  • Inactivated JomPrEP appOther

    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.

Study groups in NCT05325476
Study groupRoleWhat they receive
JomPrEP App GroupExperimentalParticipants 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.
Receives: Other: JomPrEP App
Treatment as usualActive comparatorParticipants 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.
Receives: Other: Inactivated JomPrEP app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HIV testing

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

    Measured: 3, 6, and 9 months post-randomization

  2. 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).

    Measured: 3, 6, and 9 months post-randomization

Secondary outcomes (1)
  1. Changes in PrEP adherence

    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.

    Measured: 3, 6, and 9 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start11 Apr 2023
  3. Primary completion12 Jul 2025
  4. Study completion12 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325476
Sponsor's protocol ID
R33TW011665
Acronym
JomPrEP
Status last verified
Jul 2025
First submitted
24 Mar 2022
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017 Nov 21;11:119-132. doi: 10.2174/1874613601711010119. eCollection 2017.

    PubMed 29290888
  • Henny KD, Wilkes AL, McDonald CM, Denson DJ, Neumann MS. A Rapid Review of eHealth Interventions Addressing the Continuum of HIV Care (2007-2017). AIDS Behav. 2018 Jan;22(1):43-63. doi: 10.1007/s10461-017-1923-2.

    PubMed 28983684
  • Conserve DF, Jennings L, Aguiar C, Shin G, Handler L, Maman S. Systematic review of mobile health behavioural interventions to improve uptake of HIV testing for vulnerable and key populations. J Telemed Telecare. 2017 Feb;23(2):347-359. doi: 10.1177/1357633X16639186. Epub 2016 Jul 9.

    PubMed 27056905
  • Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873.

    PubMed 29343463
  • WHO. mHealth: New horizons for health through mobile technologies: second global survey on eHealth. Geneva, Switzerland2011.

  • Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013;10(1):e1001363. doi: 10.1371/journal.pmed.1001363. Epub 2013 Jan 15.

    PubMed 23458994
  • Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.

    PubMed 21071074
  • Milward J, Lynskey M, Strang J. Solving the problem of non-attendance in substance abuse services. Drug Alcohol Rev. 2014 Nov;33(6):625-36. doi: 10.1111/dar.12194. Epub 2014 Sep 6.

    PubMed 25196817
  • Mbuagbaw L, Mursleen S, Lytvyn L, Smieja M, Dolovich L, Thabane L. Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. BMC Health Serv Res. 2015 Jan 22;15:33. doi: 10.1186/s12913-014-0654-6.

    PubMed 25609559
  • Chawarski MC, Vicknasingam B, Mazlan M, Schottenfeld RS. Lifetime ATS use and increased HIV risk among not-in-treatment opiate injectors in Malaysia. Drug Alcohol Depend. 2012 Jul 1;124(1-2):177-80. doi: 10.1016/j.drugalcdep.2011.12.024. Epub 2012 Jan 21.

    PubMed 22266088
  • Fendrich M, Avci O, Johnson TP, Mackesy-Amiti ME. Depression, substance use and HIV risk in a probability sample of men who have sex with men. Addict Behav. 2013 Mar;38(3):1715-8. doi: 10.1016/j.addbeh.2012.09.005. Epub 2012 Sep 24.

    PubMed 23254224
  • Daskalopoulou M, Rodger A, Phillips AN, Sherr L, Speakman A, Collins S, Elford J, Johnson MA, Gilson R, Fisher M, Wilkins E, Anderson J, McDonnell J, Edwards S, Perry N, O'Connell R, Lascar M, Jones M, Johnson AM, Hart G, Miners A, Geretti AM, Burman WJ, Lampe FC. Recreational drug use, polydrug use, and sexual behaviour in HIV-diagnosed men who have sex with men in the UK: results from the cross-sectional ASTRA study. Lancet HIV. 2014 Oct;1(1):e22-31. doi: 10.1016/S2352-3018(14)70001-3. Epub 2014 Sep 7.

    PubMed 26423813
  • Hirshfield S, Remien RH, Humberstone M, Walavalkar I, Chiasson MA. Substance use and high-risk sex among men who have sex with men: a national online study in the USA. AIDS Care. 2004 Nov;16(8):1036-47. doi: 10.1080/09540120412331292525.

    PubMed 15511735
  • Van Tieu H, Koblin BA. HIV, alcohol, and noninjection drug use. Curr Opin HIV AIDS. 2009 Jul;4(4):314-8. doi: 10.1097/COH.0b013e32832aa902.

    PubMed 19532070
  • Halkitis PN, Parsons JT. Recreational Drug Use and HIV-Risk Sexual Behavior Among Men Frequenting Gay Social Venues. Journal of Gay & Lesbian Social Services. 2002;14(4):19-38.

Questions about this trial

What is this clinical trial studying?

A study testing JomPrEP App and Inactivated JomPrEP app in people with HIV Prevention Program, run by University of Connecticut at 2 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HIV testing (time frame: 3, 6, and 9 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325476, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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