Clinical trial NCT05044013: Testing of the Smartphone App to Enhance HIV Prevention Cascade Among Malaysian MSM
Official title: Training in mHealth Prevention With MSM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention Program
Keywords: mobile application
PrEP
mHealth
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: Yale University
First posted: 2021-09-14
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the JomPrEP app using percentages of individuals screened
timeFrame: 6 months
measure: Feasibility of the JomPrEP app using percentages of individuals eligible
timeFrame: 6 months
measure: Feasibility of the JomPrEP app using percentages of individuals enrolled
timeFrame: 6 months
measure: Feasibility of the JomPrEP app using percentages of individuals retained
timeFrame: 6 months
measure: Feasibility of the JomPrEP app using the percentage of participants that accessed the app
timeFrame: 6 months
measure: Acceptability of the JomPrEP app based on the subjective usability measure
timeFrame: 6 months
measure: Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews
timeFrame: 6 months
Secondary outcomes:
measure: Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
timeFrame: 3 months
measure: Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
timeFrame: 6 months
measure: Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
timeFrame: 3 months
measure: Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
timeFrame: 6 months
measure: Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Centre of Excellence For Research in AIDS (CERiA)
Study officials:
affiliation: University of Connecticut
name: Roman Shrestha, PhD
role: PRINCIPAL_INVESTIGATOR
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