An interventional study of MyChoices in HIV, Sexually Transmitted Diseases and Pre-exposure Prophylaxis, sponsored by Fenway Community Health. Completed at 2 sites in United States. Open to male participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Fenway Community Health · Not applicable, Interventional, and Prevention
This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).
"MyChoices", an app adapted from HealthMindr and developed using iterative feedback from youth, is being refined to to maximize acceptability among YMSM. "MyChoices" was guided by the Social Cognitive Theory (SCT) model and includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences in order to impact behavior change. (1) Tracking and Self-Monitoring HIV Risk: In order to target self-regulation, brief surveys within the app are used to assess behavioral patterns of YMSM, particularly around sexual relationships, which are then used to help customize the app for each user. (2) HIV and sexually transmitted infection (STI) Prevention Information: In order to improve self-efficacy for HIV testing and HIV prevention overall, quizzes and infographics that appeal to YMSM have been incorporated into the app, focusing on promotion of HIV prevention and regular HIV testing. The app also allows users to order OraQuick HIV home testing kits and STI home collection kits (for rectal and urethral gonorrhea and Chlamydia and syphilis). Additionally, the app includes information on testing sites and local PrEP clinics (e.g., telephone, address, hours of testing, etc), and external links to specific site webpages that are near the user (determined using GPS technology). (3) HIV Testing Plan: Acknowledging the central role of goal setting and environmental influences on health behavior, the app allows users to create a HIV testing plan by allowing them to compare and choose different screening options (e.g., home self-testing, antigen, rapid). Questions about HIV transmission behaviors and testing history are then asked to create a tailored testing plan. After a HIV testing plan is developed, users have the option to customize reminders for the timeframe selected (e.g., user is pinged every 3 months as a reminder to get tested). Users are able to select from a list of phrases or create their own to ensure privacy. Moreover, geofencing technology allows users to be notified when in the vicinity of testing locations, based on the Geo Positioning System (GPS) location, during the testing timeframe.
This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 60 is below the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Fenway Community Health is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:
Exclusion Criteria:
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Behavioral: MyChoices
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Acceptability: System Usability Scale
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
Time frame: 3 months
Feasibility: Frequency of Logins
Number of individuals who logged into app at least one time after set up
Time frame: 3 months
Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Self-report having tested for HIV over follow up
Time frame: 6 months
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Self-report of participants reporting PrEP initiation anytime over study follow up
Time frame: 6 months
Number of Times Participants Used Distinct App Components
The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed
Time frame: 3 months
App Content and Functionality Most Utilized
We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up
Time frame: 3 months
Number of HIV Home Testing Kits Ordered
Number of Participants who ordered at least one HIV home testing kit over follow up
Time frame: 6 months
| Milestone | MyChoices | Standard of Care |
|---|---|---|
| Started | 40 | 20 |
| 3 month visit | 37 | 20 |
| Completed | 34 | 20 |
| Not completed | 6 | 0 |
| Withdrew: Lost to follow-up | 6 | 0 |
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
| score on a scale | MyChoices |
|---|---|
| Acceptability: System Usability Scale | 75.76 ± 10.72 |
Number of individuals who logged into app at least one time after set up
| Participants | MyChoices |
|---|---|
| Feasibility: Frequency of Logins | 31 |
Self-report having tested for HIV over follow up
| Participants | MyChoices | Standard of Care |
|---|---|---|
| Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | 27 | 13 |
Self-report of participants reporting PrEP initiation anytime over study follow up
| Participants | MyChoices | Standard of Care |
|---|---|---|
| Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP | 3 | 3 |
The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed
| App components used | MyChoices |
|---|---|
| Number of Times Participants Used Distinct App Components | 100.58 ± 86.09 |
We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up
| Participants | MyChoices |
|---|---|
| HIV test plan | 30 |
| Location search | 26 |
| FAQs | 22 |
| Ordering supplies | 31 |
Number of Participants who ordered at least one HIV home testing kit over follow up
| Participants | MyChoices |
|---|---|
| Number of HIV Home Testing Kits Ordered | 25 |
Collected over For each participant, adverse event data were collected for 6 months. Across the study, AE data was collected from 11/13/2018 through 11/05/2019.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MyChoices | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Standard of Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | MyChoices | Standard of Care | Total |
|---|---|---|---|
| Mean | 21.25 ± 2.08 | 21.95 ± 2.26 | 21.48 ± 2.15 |
| Sex: Female, Male(Participants) | MyChoices | Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 40 | 20 | 60 |
| Ethnicity (NIH/OMB)(Participants) | MyChoices | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 34 | 17 | 51 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MyChoices | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| White | 29 | 9 | 38 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | MyChoices | Standard of Care | Total |
|---|---|---|---|
| United States — Boston, MA | 20 | 10 | 30 |
| United States — Bronx, NY | 6 | 4 | 10 |
| United States — Chapel Hill, NC | 14 | 6 | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Raw data will be available to outside individuals through contacting the multiple principal investigators (MPIs) at two different times. The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
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Fenway Community Health