Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM

HIV Prevention Program Clinical Trial

— JomPrEP  

Official title:

Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325476
• Other study ID #: R33TW011665
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Connecticut
• Contact: Roman Shrestha, MPH, PhD
• Phone: (860) 486-2446
• Email: roman.shrestha[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention Program

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	CERiA	Kuala Lumpur
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (4)

Lead Sponsor	Collaborator
University of Connecticut	National Institutes of Health (NIH), University of Malaya, Yale University

Country where clinical trial is conducted

Malaysia, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	3, 6, and 9 months post-randomization