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

HIV Prevention Program Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052411
• Other study ID #: R21TW011665
• Status: Completed
• Phase: N/A
• Start date: March 13, 2022
• Est. completion date: April 24, 2022

Study information

• Verified date: August 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 24, 2022
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention Program

Intervention

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.

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	University of Malaya, Yale University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Usability of the JomPrEP app through app analytics	The investigators will collect app analytics, such as session duration to assess usability.	1 month
Primary	Usability of the JomPrEP app through app analytics	The investigators will collect app analytics, such as pages visited to assess usability.	1 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Feasibility 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 feasibility. The higher the score, the better the outcome. Minimum score for the scale is 0, highest score is 100.	1 month
Secondary	Feasibility of the JomPrEP app through calculated proportions	Proportion accessing the app >0.60 will be considered the minimum criteria for feasibility.	1 month

External Links

•   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.
•   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.
•   Brooke J, Jordan P, Thomas B, Weerdmeester B, McClelland I. Usability evaluation in industry. SUS: a'quick and dirty'usability scale. 1996:184-194.
•   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).