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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Training in mHealth Prevention With MSM

Conditions
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HIV Prevention Program

Intervention / Treatment
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* Other: Full access to JomPrEP app
* Other: inactivated JomPrEP app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JomPrEP App Group<br>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<br>* 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.<br>|
| Active Comparator: Control Group<br>Participants in the control group will receive the JomPrEP app with major intervention features inactivated. | Other: inactivated JomPrEP app<br>* Only information and resources for PrEP services will be available along with access to risk assessment tools.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the JomPrEP app using percentages of individuals screened | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile application, PrEP, mHealth