NCT05052411

Brief Summary

This project will involve beta testing of the JomPrEP app to assess its usability and acceptability among Malaysian MSM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 25, 2021

Last Update Submit

August 31, 2022

Conditions

Keywords

PrEPmHealthmobile application

Outcome Measures

Primary Outcomes (9)

  • Usability of the JomPrEP app through the System Usability Scale

    The Systems Usability Scale (SUS) will be used to assess the subjective usability of the app.

    1 month

  • Usability of the JomPrEP app through app analytics

    The investigators will collect app analytics, such as the number of log-ins to assess usability.

    1 month

  • Usability of the JomPrEP app through app analytics

    The investigators will collect app analytics, such as session duration to assess usability.

    1 month

  • Usability of the JomPrEP app through app analytics

    The investigators will collect app analytics, such as pages visited to assess usability.

    1 month

  • Usability of the JomPrEP app through app analytics

    The investigators will collect app analytics, such as frequency of use of app components to assess usability.

    1 month

  • Usability of the JomPrEP app through app analytics

    The investigators will collect app analytics, such as the duration of use of app components to assess usability.

    1 month

  • Usability of the JomPrEP app through interviews

    Participants will be asked to provide qualitative feedback on functionality, performance, and errors encountered, motivation to use the app, overall experiences using the app, feedback for further refinement, and subjective impact of the app on HIV prevention outcomes.

    1 month

  • Acceptability of the JomPrEP app through the System Usability Scale

    Point estimates for mean acceptability ≥50 for the System Usability Scale will be considered the minimum criteria for acceptability. The higher the score, the better the outcome. Minimum score for the scale is 0, maximum score is 100.

    1 month

  • Acceptability of the JomPrEP app through calculated proportions

    Proportion of participants accessing the app \>0.60 will be considered the minimum criteria for acceptability.

    1 month

Secondary Outcomes (2)

  • Feasibility of the JomPrEP app through the System Usability Scale

    1 month

  • Feasibility of the JomPrEP app through calculated proportions

    1 month

Study Arms (1)

Expanded beta testing of the JomPrEP app

EXPERIMENTAL

App usage assessments and analytics over a 1-month period.

Other: App usage assessments and analytics

Interventions

All participants will be given a brief overview of the purpose of the study followed by a survey on participant characteristics and barriers to accessing HIV testing and PrEP uptake and P/SUD support services. The participant will be observed downloading the JomPrEP app and instructed with a brief tutorial on the onboarding process. The participant will be told to keep the app for 1 month and encouraged to use all app components. At 30 days, the participant will complete a post-survey, to which the Systems Usability Scale will be added. App analytics will also be collected (e.g., the number of logins). Participants will be asked to provide feedback on functionality, performance, and errors encountered, motivation to use the app, overall experiences using the app, feedback for further refinement, and subjective impact of the app on HIV prevention.

Expanded beta testing of the JomPrEP app

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCis-gender men.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Malaysia

Location

Related Publications (1)

  • Shrestha R, Altice FL, Khati A, Azwa I, Gautam K, Gupta S, Sullivan PS, Ni Z, Kamarulzaman A, Phiphatkunarnon P, Wickersham JA. Clinic-Integrated Smartphone App (JomPrEP) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Mixed Methods Evaluation of Usability and Acceptability. JMIR Mhealth Uhealth. 2023 Feb 16;11:e44468. doi: 10.2196/44468.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: We will enroll 50 MSM for a total of 1 month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 22, 2021

Study Start

March 13, 2022

Primary Completion

April 24, 2022

Study Completion

April 24, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations