Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM

• Sponsor: University of Connecticut (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05052411
• Collaborator: University of Malaya (Other), Yale University (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.6
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Prevention Program	Other: App usage assessments and analytics	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: We will enroll 50 MSM for a total of 1 month.We will enroll 50 MSM for a total of 1 month.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM
• Actual Study Start Date: Mar 11, 2022
• Actual Primary Completion Date: Mar 24, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Expanded beta testing of the JomPrEP app App usage assessments and analytics over a 1-month period.

Other: App usage assessments and analytics; 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.

Outcome Measures

Primary Outcome Measures

1. Usability of the JomPrEP app through the System Usability Scale [1 month]

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

2. Usability of the JomPrEP app through app analytics [1 month]

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

3. Usability of the JomPrEP app through app analytics [1 month]

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

4. Usability of the JomPrEP app through app analytics [1 month]

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

5. Usability of the JomPrEP app through app analytics [1 month]

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

6. Usability of the JomPrEP app through app analytics [1 month]

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

7. Usability of the JomPrEP app through interviews [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.

8. Acceptability of the JomPrEP app through the System Usability Scale [1 month]

   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.

9. Acceptability of the JomPrEP app through calculated proportions [1 month]

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

Secondary Outcome Measures

1. Feasibility of the JomPrEP app through the System Usability Scale [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.

2. Feasibility of the JomPrEP app through calculated proportions [1 month]

   Proportion accessing the app >0.60 will be considered the minimum criteria for feasibility.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya	Kuala Lumpur		Malaysia

Sponsors and Collaborators

• University of Connecticut
• University of Malaya
• Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Roman Shrestha, Assistant Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT05052411
• Other Study ID Numbers: R21TW011665
• First Posted: Sep 22, 2021
• Last Update Posted: Apr 5, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Roman Shrestha, Assistant Professor, University of Connecticut: PrEP; mHealth; mobile application

Study Results

No Results Posted as of Apr 5, 2022