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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19HD089881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| Montefiore Medical Center | OTHER |
| Emory University | OTHER |
| Brown University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyChoices | Experimental | 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. |
|
| Standard of Care | No Intervention | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyChoices | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Feasibility: Frequency of Logins | Number of individuals who logged into app at least one time after set up | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | Self-report having tested for HIV over follow up | 6 months |
| Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP |
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Inclusion Criteria:
No HIV test in the past 3 months (self-reported).
Not known to be HIV-infected (self-reported).
Not currently taking PrEP (self-report).
Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 3 only), has an active data plan, and willing to download the MyChoices application.
Willing to attend an in-person baseline study visit in Boston or the Bronx and complete online follow-up visits.
Able to understand, read, and speak English.
Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months.
Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:
Exclusion Criteria:
Cisgender male
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| Name | Affiliation | Role |
|---|---|---|
| Katie B Biello, PhD, MPH | Protocol Co-Chair, Research Study MPI | Principal Investigator |
| Kenneth H Mayer, MD | Fenway Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Health Center | Boston | Massachusetts | 02215 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33759792 | Derived | Biello KB, Hill-Rorie J, Valente PK, Futterman D, Sullivan PS, Hightow-Weidman L, Muessig K, Dormitzer J, Mimiaga MJ, Mayer KH. Development and Evaluation of a Mobile App Designed to Increase HIV Testing and Pre-exposure Prophylaxis Use Among Young Men Who Have Sex With Men in the United States: Open Pilot Trial. J Med Internet Res. 2021 Mar 24;23(3):e25107. doi: 10.2196/25107. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | MyChoices | 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. Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing. |
| FG001 | Standard of Care | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MyChoices | 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. Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome; One person had missing data for this item. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MyChoices | 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. Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Biello | Brown University | 401-863-3082 | katie_biello@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2019 | Oct 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| OTHER |
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Self-report of participants reporting PrEP initiation anytime over study follow up
| 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 | 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 | 3 months |
| Number of HIV Home Testing Kits Ordered | Number of Participants who ordered at least one HIV home testing kit over follow up | 6 months |
| The Bronx |
| New York |
| 10467 |
| United States |
| Standard of Care |
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
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| Primary | Feasibility: Frequency of Logins | Number of individuals who logged into app at least one time after set up | Error in paradata collection resulted in missing app data for 7 participants | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | Self-report having tested for HIV over follow up | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP | Self-report of participants reporting PrEP initiation anytime over study follow up | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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 | Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants. | Posted | Mean | Standard Deviation | App components used | 3 months |
|
|
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| Secondary | 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 | Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants. | Posted | Count of Participants | Participants | 3 months |
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|
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| Secondary | Number of HIV Home Testing Kits Ordered | Number of Participants who ordered at least one HIV home testing kit over follow up | Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. | Posted | Count of Participants | Participants | 6 months |
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|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Standard of Care | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
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| Ordering supplies |
|