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Trial record 1 of 1 for:    NCT03179319
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Mobile-Based Application "MyChoices"

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ClinicalTrials.gov Identifier: NCT03179319
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Fenway Community Health
University of North Carolina
Montefiore Medical Center
Emory University
Information provided by (Responsible Party):
Brown University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
HIV Sexually Transmitted Diseases Pre-exposure Prophylaxis Risk Reduction Behavioral: MyChoices Not Applicable

Detailed Description:

"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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobile-Based Application "MyChoices" to Increase Uptake of HIV Testing, Detection of New HIV Infections, and Linkage to Care and Prevention Services by Young Men Who Have Sex With Men
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

No Intervention: Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.



Primary Outcome Measures :
  1. Acceptability: System Usability Scale [ Time Frame: 6 months ]
    System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app.

  2. Feasibility: Frequency of logins [ Time Frame: 6 months ]
    Frequency of logins


Secondary Outcome Measures :
  1. Frequency of use of app components [ Time Frame: 6 months ]
    App usage data

  2. App content and functionalities most and least utilized [ Time Frame: 6 months ]
    App usage data

  3. Number of HIV/STI home testing kits, condoms and lube requested [ Time Frame: 6 months ]
    Usage data

  4. Preliminary efficacy: HIV testing frequency [ Time Frame: 6 months ]
    Submitted evidence of HIV test results; Self-report

  5. Preliminary efficacy: PrEP uptake [ Time Frame: 6 months ]
    Self-report of linkage to PrEP and PrEP utilization

  6. Sexual and drug use behaviors [ Time Frame: 6 months ]
    Self report

  7. Access to and utilization of health care [ Time Frame: 6 months ]
    Self report

  8. Social Cognitive Theory (SCT) model constructs for HIV/STI testing and PrEP uptake, including self regulation, self efficacy and environmental influences [ Time Frame: 6 months ]
    Questionnaires regarding HIV testing and PrEP uptake self regulation, self efficacy and environmental influences



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender male
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. at least one episode of condomless anal intercourse with an HIV-infected or unknown HIV status male or transfemale partner during the last 6 months; or
    2. anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or
    3. exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
    4. sex with a male or transfemale partner and has had an STI during the last 6 months.

Exclusion Criteria:

  • Any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
  • Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product and evidence of vaccine-induced seropositivity.
  • Known to be HIV-infected.
  • Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179319


Contacts
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Contact: Katie B Biello, PhD, MPH 4018633082 katie_biello@brown.edu
Contact: Elliot Marrow 6179276469 emarrow@fenwayhealth.org

Locations
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United States, Massachusetts
Fenway Health Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Julian Dormitzer, RN    617-927-6309    jdormitzer@fenwayheath.org   
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Donna Futterman, MD    718-882-0232    dfutterman@adolescentaids.org   
Contact: Helen Nazario, DNP    7188820232    hnazario@adolescentaids.org   
Sponsors and Collaborators
Brown University
Fenway Community Health
University of North Carolina
Montefiore Medical Center
Emory University
Investigators
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Principal Investigator: Katie B Biello, PhD, MPH Protocol Co-Chair, Research Study MPI
Principal Investigator: Kenneth H Mayer, MD Fenway Health Center

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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03179319     History of Changes
Other Study ID Numbers: 1U19HD089881 (SubProject 8784)
1U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brown University:
PrEP
HIV testing
Sexually transmitted disease (STD) testing
Mobile app
Young men who have sex with men
Technology

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female