Clinical trial NCT03179319: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: Montefiore Medical Center
name: Emory University
name: Brown University
First posted: 2017-06-07
Enrollment: 60
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

  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.

Primary outcomes:
measure: Acceptability: System Usability Scale
timeFrame: 3 months
measure: Feasibility: Frequency of Logins
timeFrame: 3 months
Secondary outcomes:
measure: Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
timeFrame: 6 months
measure: Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
timeFrame: 6 months
measure: Number of Times Participants Used Distinct App Components
timeFrame: 3 months
measure: App Content and Functionality Most Utilized
timeFrame: 3 months
measure: Number of HIV Home Testing Kits Ordered
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Protocol Co-Chair, Research Study MPI
name: Katie B Biello, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenway Health Center
name: Kenneth H Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.