- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052411
Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Given the evolving HIV epidemic among MSM 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 PrEP and that incorporates screening and support for P/SUD for Malaysian MSM. We now plan to conduct expanded beta testing of the newly designed JomPrEP app to assess its usability and acceptability among Malaysian MSM.
Following wireframing and usability testing, Keymind (an experienced mobile app development company that has significant experience in building HIPAA-compliant apps, including HealthMindr) will apply a user interface (UI) design (i.e., colors/branding) to the interactive prototype, followed by the final development of the app (beta version). The objective of this study is to beta test this app to identify potential bugs and to ensure its usability in a real-world setting.
As part of the expanded beta testing, we will also evaluate the design, functionality, and usability of the JomPrEP app. This step is a critical stage of app development and will increase the ability of our research team to develop an acceptable and effective app.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kuala Lumpur, Malaysia
- University of Malaya
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Expanded beta testing of the JomPrEP app
App usage assessments and analytics over a 1-month period.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of the JomPrEP app through the System Usability Scale
Time Frame: 1 month
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The Systems Usability Scale (SUS) will be used to assess the subjective usability of the app.
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1 month
|
Usability of the JomPrEP app through app analytics
Time Frame: 1 month
|
The investigators will collect app analytics, such as the number of log-ins to assess usability.
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1 month
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Usability of the JomPrEP app through app analytics
Time Frame: 1 month
|
The investigators will collect app analytics, such as session duration to assess usability.
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1 month
|
Usability of the JomPrEP app through app analytics
Time Frame: 1 month
|
The investigators will collect app analytics, such as pages visited to assess usability.
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1 month
|
Usability of the JomPrEP app through app analytics
Time Frame: 1 month
|
The investigators will collect app analytics, such as frequency of use of app components to assess usability.
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1 month
|
Usability of the JomPrEP app through app analytics
Time Frame: 1 month
|
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
Time Frame: 1 month
|
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.
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1 month
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Acceptability of the JomPrEP app through the System Usability Scale
Time Frame: 1 month
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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.
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1 month
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Acceptability of the JomPrEP app through calculated proportions
Time Frame: 1 month
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Proportion of participants accessing the app >0.60 will be considered the minimum criteria for acceptability.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the JomPrEP app through the System Usability Scale
Time Frame: 1 month
|
Point estimates for mean acceptability ≥50 for the System Usability Scale will be considered the minimum criteria for feasibility.
The higher the score, the better the outcome.
Minimum score for the scale is 0, highest score is 100.
|
1 month
|
Feasibility of the JomPrEP app through calculated proportions
Time Frame: 1 month
|
Proportion accessing the app >0.60 will be considered the minimum criteria for feasibility.
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- Naeem F, Syed Y, Xiang S, et al. Development, Testing and Reporting of Mobile Apps for Psycho-social Interventions: Lessons from the Pharmaceuticals. Journal of Medical Diagnostic Methods. 2015;4(4).
- Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability Scale. International Journal of Human-Computer Interaction. 2008;24(6):574-594.
- Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J. Usability Studies. 2009;4(3):114-123.
- Brooke J, Jordan P, Thomas B, Weerdmeester B, McClelland I. Usability evaluation in industry. SUS: a'quick and dirty'usability scale. 1996:184-194.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21TW011665 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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