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

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ClinicalTrials.gov Identifier: NCT05325476
Recruitment Status : Not yet recruiting
First Posted : April 13, 2022
Last Update Posted : April 13, 2022
Sponsor:
Collaborators:
University of Malaya
National Institutes of Health (NIH)
Yale University
Information provided by (Responsible Party):
Roman Shrestha, University of Connecticut

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Program Other: JomPrEP App Other: Inactivated JomPrEP app Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing of the JomPrEP App for HIV Prevention Among Malaysian MSM
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gender men
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05325476


Contacts
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Contact: Roman Shrestha, MPH, PhD (860) 486-2446 roman.shrestha@uconn.edu
Contact: Antoine Khati, MD +1(959)929-9619 antoine.khati@uconn.edu

Locations
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Malaysia
Centre of Excellence For Research in AIDS (CERiA)
Kuala Lumpur, Malaysia
University of Malaya
Kuala Lumpur, Malaysia
Sponsors and Collaborators
University of Connecticut
University of Malaya
National Institutes of Health (NIH)
Yale University
Publications:
WHO. mHealth: New horizons for health through mobile technologies: second global survey on eHealth. Geneva, Switzerland2011.
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.
Shrestha R, Lim SH, Altice FL, Kamarulzaman A, Wickersham J. Perception and acceptability of mHealth-based intervention for HIV prevention among men who have sex with men (MSM) in Malaysia. In preparation. 2019.
Malaysian Communications and Multimedia Commission. Internet users survey: 2017. 2017; https://mcmc.gov.my/skmmgovmy/media/General/pdf/HPUS2017.pdf. Accessed May 1, 2019.

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Responsible Party: Roman Shrestha, Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT05325476    
Other Study ID Numbers: R33TW011665
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022

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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
Keywords provided by Roman Shrestha, University of Connecticut:
PrEP
mHealth
Smartphone app
mobile app
men who have sex with men