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Clinical Trials/NCT03179319
NCT03179319
Completed
N/A

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

Fenway Community Health2 sites in 1 country60 target enrollmentJuly 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV
Sponsor
Fenway Community Health
Enrollment
60
Locations
2
Primary Endpoint
Acceptability: System Usability Scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
January 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Fenway Community Health
Responsible Party
Principal Investigator
Principal Investigator

Kenneth H. Mayer, MD

Principal Investigator

Fenway Community Health

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

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.

Outcomes

Primary Outcomes

Acceptability: System Usability Scale

Time Frame: 3 months

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

Time Frame: 3 months

Number of individuals who logged into app at least one time after set up

Secondary Outcomes

  • Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP(6 months)
  • Number of Times Participants Used Distinct App Components(3 months)
  • Number of HIV Home Testing Kits Ordered(6 months)
  • Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV(6 months)
  • App Content and Functionality Most Utilized(3 months)

Study Sites (2)

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