Testing of the Smartphone App to Enhance HIV Prevention Cascade Among Malaysian MSM

November 21, 2023 updated by: Roman Shrestha, University of Connecticut

Training in mHealth Prevention With MSM

The investigators will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

mHealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations 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 care for marginalized populations, - all features crucial for HIV prevention in MSM in Malaysia. Results from the investigators' studies show Malaysian MSM often do not get HIV tested or initiate PrEP. 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 facilitating prevention services delivery and health decision-making in a confidential, less-stigmatizing, and convenient manner. Overall smartphone growth in Malaysia (63% in 2015 to 89% in 2017), and the investigators' parallel work with MSM indicates that nearly all (>97%) MSM own a smartphone. Findings from qualitative interviews with MSM further indicate preferences for interfacing with 'apps' rather than health professionals as well as local stakeholders indicating strong interest in using such platform to deliver HIV prevention services align with developing culturally tailored mHealth strategies and to engage MSM in virtual communication with providers - all embedded within one app.

To the investigators' knowledge however, no mHealth intervention has been developed to improve access to HIV prevention services in Malaysia. The investigators, therefore, propose to pilot test their new clinic-affiliated app (JomPrEP) to promote HIV testing and PrEP uptake in Malaysian MSM. They will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.

The investigators will enroll 90 participants who will be randomized (1:1) to receive either the JomPrEP app or the control group and assessed at 3- and 6-months. Randomization will be stratified by ATS use (16% to 24%) and age. They will conduct exit interviews with participants and clinical staff to examine the barriers and facilitators to the app and obtain feedback to further optimize the app.

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Centre of Excellence For Research in AIDS (CERiA)
        • Contact:
          • Rumana Saifi, PhD

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: MSM

  • HIV-negative MSM
  • Age more than or equal to 18
  • Cis-gender men
  • Condomless sex in the last 30 days
  • Own a smartphone

Exclusion Criteria:

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

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 JomPrEP group will be provided with full app access and will be encouraged to use all features of the app.
Other: Full access to JomPrEP app
All participants will receive the JomPrEP app with access to all of its features which include: customizable page (using avatars and pseudonyms); visual dashboard (track and visualize progress); HIV testing plan (create plan for HIV testing, order self-testing kits, testing site locator); PrEP Care Plan (PrEPxpress, automated reminders for follow-up care, labs, delivery); chat function and discussion forum; tailored messages and reminders; assessment center (weekly assessment on adherence to PrEP, HIV risk, mood); knowledge center (resources on HIV testing and PrEP); Mental health support (screen for P/SUD, counseling feedback, referral to support services); Integration of provider locator (provides users with a GPS enabled map for PrEP and mental health support providers in Malaysia) and Gamification (offers extrinsic motivation by rewarding points/milestones for doing activities within the app). Participants can also contact the RA using the chat function for support.
Active Comparator: Control Group
Participants in the control group will receive the JomPrEP app with major intervention features inactivated.
Other: inactivated JomPrEP app
Only information and resources for PrEP services will be available along with access to risk assessment tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the JomPrEP app using percentages of individuals screened
Time Frame: 6 months
The investigators will use the percentage of individuals screened to determine the feasibility of the JomPrEP app
6 months
Feasibility of the JomPrEP app using percentages of individuals eligible
Time Frame: 6 months
The investigators will use the percentage of individuals eligible to determine the feasibility of the JomPrEP app
6 months
Feasibility of the JomPrEP app using percentages of individuals enrolled
Time Frame: 6 months
The investigators will use the percentage of individuals enrolled to determine the feasibility of the JomPrEP app
6 months
Feasibility of the JomPrEP app using percentages of individuals retained
Time Frame: 6 months
The investigators will use the percentage of individuals retained to determine the feasibility of the JomPrEP app
6 months
Feasibility of the JomPrEP app using the percentage of participants that accessed the app
Time Frame: 6 months
The investigators will determine the percentage of participants that accessed the app, with ≥60% of participants accessing app as lower threshold. The higher the percentage, the higher the feasibility.
6 months
Acceptability of the JomPrEP app based on the subjective usability measure
Time Frame: 6 months
Acceptability will be based on descriptive statistics from the subjective usability measure, with a target mean score of ≥ 50. The higher the score, the higher the acceptability. Minimum score for the scale is 0, highest is 100.
6 months
Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews
Time Frame: 6 months
Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.
6 months
Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews
Time Frame: 6 months
Acceptability will be based on analysis of qualitative data which includes barriers and facilitators.
6 months
Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews
Time Frame: 6 months
Acceptability will be based on analysis of qualitative data which includes usability concerns.
6 months
Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews
Time Frame: 6 months
Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
Time Frame: 3 months
The investigators will measure PrEP adherence (using dried blood spots) at 3 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC.
3 months
Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
Time Frame: 6 months
The investigators will measure PrEP adherence (using dried blood spots) at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC
6 months
Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
Time Frame: 3 months
The investigators will measure PrEP adherence using the visual analogue scale at 3 months.
3 months
Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
Time Frame: 6 months
The investigators will measure PrEP adherence using the visual analogue scale at 6 months.
6 months
Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP
Time Frame: 6 months
Preliminary Efficacy of the app will be calculated using the proportion of participants who persist on PrEP. Persistence on PrEP is measured on the app when completing PrEP care.
6 months

Collaborators and Investigators

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

Sponsor

University of Connecticut

Collaborators

Yale University
University of Malaya

Investigators

  • Principal Investigator: Roman Shrestha, PhD, University of Connecticut

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

Helpful Links

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)

November 15, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K01DA051346 (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

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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