NCT03179319

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

June 1, 2017

Results QC Date

October 28, 2020

Last Update Submit

November 19, 2020

Conditions

HIVSexually Transmitted DiseasesPre-exposure ProphylaxisRisk Reduction

Keywords

PrEPHIV testingSexually transmitted disease (STD) testingMobile appYoung men who have sex with menTechnology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV

    6 months

  • Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP

    6 months

  • Number of Times Participants Used Distinct App Components

    3 months

  • App Content and Functionality Most Utilized

    3 months

  • Number of HIV Home Testing Kits Ordered

    6 months

Study Arms (2)

MyChoices

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Interventions

MyChoicesBEHAVIORAL

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.

MyChoices

Eligibility Criteria

Age15 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender male
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fenway Health Center

Boston, Massachusetts, 02215, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • 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.

    PMID: 33759792DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Katie Biello
Organization
Brown University
katie_biello@brown.edu
401-863-3082

Study Officials

  • Katie B Biello, PhD, MPH

    Protocol Co-Chair, Research Study MPI

    PRINCIPAL INVESTIGATOR

  • Kenneth H Mayer, MD

    Fenway Health Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 7, 2017

Study Start

July 1, 2017

Primary Completion

December 28, 2019

Study Completion

January 31, 2020

Last Updated

December 16, 2020

Results First Posted

December 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Locations

US(2)