HIV Prevention ProgramNCT05052411
Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM
A study testing App usage assessments and analytics in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.
Trial summary
This project will involve beta testing of the JomPrEP app to assess its usability and acceptability among Malaysian MSM. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention Program
- What is being tested?
- App usage assessments and analytics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Mar 2022to 24 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-negative MSM
- Age more than or equal to 18
- Cis-gender men
- Condomless sex in the last 30 days
- Own a smartphone
Who cannot join
- Unable to provide informed consent
- Unable to read and understand English or Bahasa Malaysia
Trial locations and contacts
1 site in 1 country.
About this study
This project will involve beta testing of the JomPrEP app to assess its usability and acceptability among Malaysian MSM.
Read the 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.
- Conditions
- HIV Prevention Program
- Being tested
- App usage assessments and analytics
- Keywords
- PrEP, mHealth, mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App usage assessments and analyticsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Expanded beta testing of the JomPrEP app | Experimental | App usage assessments and analytics over a 1-month period. Receives: Other: App usage assessments and analytics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Usability of the JomPrEP app through app analytics
The investigators will collect app analytics, such as session duration to assess usability.
Measured: 1 month
Usability of the JomPrEP app through app analytics
The investigators will collect app analytics, such as pages visited to assess usability.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
Feasibility of the JomPrEP app through calculated proportions
Proportion accessing the app >0.60 will be considered the minimum criteria for feasibility.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start13 Mar 2022
- Primary completion24 Apr 2022
- Study completion24 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Prevention ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will enroll 50 MSM for a total of 1 month.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Yale University
- Responsible party
- Principal investigator, Roman Shrestha, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052411
- Sponsor's protocol ID
- R21TW011665
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36795465
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM
- ClinicalTrials.gov ID
- NCT05052411
- Acronym / sponsor ID
- R21TW011665
- Conditions
- HIV Prevention Program
- Keywords
- PrEP, mHealth, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- University of Malaya, Yale University
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will involve beta testing of the JomPrEP app to assess its usability and acceptability among Malaysian MSM.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will enroll 50 MSM for a total of 1 month.
| Arm | Type | Receives |
|---|---|---|
| Expanded beta testing of the JomPrEP app | Experimental | Other: App usage assessments and analyticsApp usage assessments and analytics over a 1-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-negative MSM
- Age more than or equal to 18
- Cis-gender men
- Condomless sex in the last 30 days
- Own a smartphone
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable to read and understand English or Bahasa Malaysia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App usage assessments and analyticsAll 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. | Other | Expanded beta testing of the JomPrEP app |
Primary outcome
Usability of the JomPrEP app through the System Usability Scale
Time frame: 1 month
The Systems Usability Scale (SUS) will be used to assess the subjective usability of the app.
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.
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.
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.
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.
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.
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.
Acceptability 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 acceptability. The higher the score, the better the outcome. Minimum score for the scale is 0, maximum score is 100.
Acceptability of the JomPrEP app through calculated proportions
Time frame: 1 month
Proportion of participants accessing the app >0.60 will be considered the minimum criteria for acceptability.
2 secondary outcomes
Feasibility of the JomPrEP app through the System Usability Scale
Time frame: 1 month
Feasibility of the JomPrEP app through calculated proportions
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 36795465Shrestha 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.
- 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).Link provided by the sponsor.
- Brooke J, Jordan P, Thomas B, Weerdmeester B, McClelland I. Usability evaluation in industry. SUS: a'quick and dirty'usability scale. 1996:184-194.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App usage assessments and analytics in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the JomPrEP app through the System Usability Scale (time frame: 1 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.