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Mobile-Based Application "MyChoices"

Primary Purpose

HIV, Sexually Transmitted Diseases, Pre-exposure Prophylaxis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyChoices
Sponsored by
Fenway Community Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring PrEP, HIV testing, Sexually transmitted disease (STD) testing, Mobile app, Young men who have sex with men, Technology

Eligibility Criteria

15 Years - 24 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Fenway Health Center
  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MyChoices

Standard of Care

Arm Description

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 receive local standard of care for linkage to PrEP and HIV/STI testing.

Outcomes

Primary Outcome Measures

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.
Feasibility: Frequency of Logins
Number of individuals who logged into app at least one time after set up

Secondary Outcome Measures

Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Self-report having tested for HIV over follow up
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Self-report of participants reporting PrEP initiation anytime over study follow up
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
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
Number of HIV Home Testing Kits Ordered
Number of Participants who ordered at least one HIV home testing kit over follow up

Full Information

First Posted
June 1, 2017
Last Updated
November 19, 2020
Sponsor
Fenway Community Health
Collaborators
University of North Carolina, Montefiore Medical Center, Emory University, Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT03179319
Brief Title
Mobile-Based Application "MyChoices"
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 28, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fenway Community Health
Collaborators
University of North Carolina, Montefiore Medical Center, Emory University, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
Keywords
PrEP, HIV testing, Sexually transmitted disease (STD) testing, Mobile app, Young men who have sex with men, Technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyChoices
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Intervention Type
Behavioral
Intervention Name(s)
MyChoices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability: System Usability Scale
Description
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
Title
Feasibility: Frequency of Logins
Description
Number of individuals who logged into app at least one time after set up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Description
Self-report having tested for HIV over follow up
Time Frame
6 months
Title
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Description
Self-report of participants reporting PrEP initiation anytime over study follow up
Time Frame
6 months
Title
Number of Times Participants Used Distinct App Components
Description
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
Title
App Content and Functionality Most Utilized
Description
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
Title
Number of HIV Home Testing Kits Ordered
Description
Number of Participants who ordered at least one HIV home testing kit over follow up
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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 anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie B Biello, PhD, MPH
Organizational Affiliation
Protocol Co-Chair, Research Study MPI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth H Mayer, MD
Organizational Affiliation
Fenway Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fenway Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33759792
Citation
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.
Results Reference
derived

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Mobile-Based Application "MyChoices"

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