Mobile-Based Application "MyChoices"

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

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).

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV; Risk Reduction; Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: MyChoices

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Health Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fenway Community Health
• Collaborators: Brown University; Emory University; Montefiore Medical Center; University of North Carolina
• Investigators: Principal Investigator: Katie B Biello, PhD, MPH, Protocol Co-Chair, Research Study MPI; Principal Investigator: Kenneth H Mayer, MD, Fenway Health Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 28, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: PrEP; HIV testing; Technology; Mobile app; Young men who have sex with men; Sexually transmitted disease (STD) testing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 1U19HD089881 (SubProject 8784); 1U19HD089881 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No