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Comparison of Men's Prevention Apps to Research Efficacy (COMPARE)

Primary Purpose

HIV/AIDS, Sexually Transmitted Diseases, Pre-exposure Prophylaxis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LYNX
MyChoices
Sponsored by
Public Health Foundation Enterprises, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring PrEP, HIV Testing, Sexually Transmitted Infections, Mobile app, Young men who have sex with men, Technology

Eligibility Criteria

15 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 15 to 29 years.
  • Assigned male sex at birth and male identified.
  • Self-report being HIV uninfected or HIV status-unknown at screening.
  • Self-report having not had an HIV test in the past 3 months.
  • Self-report not currently taking PrEP.
  • Self-report at least one episode of anal intercourse with a male or transfemale partner during the last 12 months.
  • Able to understand, read, and speak English.
  • Owns or leases a phone with Android platform or iOS platform, has an active data plan Has phone setting in English or Spanish, or willing to use an English or Spanish phone setting over the course of the study (Spanish setting is only for bilingual participants who speak both English and Spanish fluently)
  • Willing and able to attend an in-person baseline study visit in one of the study site areas, or willing to attend a remote online baseline study visit

Exclusion Criteria:

  • Currently enrolled in another HIV intervention study.
  • Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.
  • Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies
  • 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.
  • Not willing and/or not able to download the MyChoices and LYNX apps onto their phone

Sites / Locations

  • University of South Florida, Infectious Diseases
  • PRISM Health
  • Ayar @ Core
  • Fenway Health Center
  • Montefiore Children's Hospital
  • RAIN, Inc
  • Adolescent Initiative at Children's Hospital of Philadelphia
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

LYNX

MyChoices

Standard of Care

Arm Description

LYNX is developed using IMB model and engages youth through entering sexual diary data, earning badges, and calculating a personalized sexual protection (Sex Pro) score, which informs and motivates youth around HIV/STI testing and PrEP uptake. Behavioral skills are built through HIV/STI testing reminders, presenting options for home HIV testing and/or linkage to nearby testing services, and access to an online chat with support for HIV/STI testing and PrEP referral.

MyChoices is adapted from an app for adult MSM, HealthMindr, developed using SCT. The app aims to increase HIV testing and PrEP uptake by increasing self- regulation, self-reflection, and self-efficacy around HIV testing and PrEP uptake. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos and infographics as well as "Help me Choose," "Ordering," and geofencing functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP.

Provision of referrals to local HIV/STI testing and PrEP resources.

Outcomes

Primary Outcome Measures

Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Proportion who complete >= 1 HIV test
Efficacy for PrEP uptake: Proportion who uptake PrEP
Proportion who uptake PrEP
Efficacy for STI testing: Proportion who complete >=1 STI test
Proportion who complete >=1 STI test

Secondary Outcome Measures

Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Proportion who complete >= 1 HIV test
Efficacy for PrEP uptake: Proportion who uptake PrEP
Proportion who uptake PrEP
Efficacy for STI testing: Proportion who complete >=1 STI test
Proportion who complete >=1 STI test

Full Information

First Posted
May 17, 2019
Last Updated
July 25, 2022
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Adolescent Trials Network for HIV/AIDS Interventions, Adolescent and Young Adult Research (AYAR), CORE Center, Children's Hospital of Philadelphia, Baylor College of Medicine, University of South Florida, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fenway Community Health, San Francisco Department of Public Health, University of North Carolina, Chapel Hill, The Children's Hospital at Montefiore (CHAM), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Brown University, RAIN, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03965221
Brief Title
Comparison of Men's Prevention Apps to Research Efficacy
Acronym
COMPARE
Official Title
Comparison of Men's Prevention Apps to Research Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Adolescent Trials Network for HIV/AIDS Interventions, Adolescent and Young Adult Research (AYAR), CORE Center, Children's Hospital of Philadelphia, Baylor College of Medicine, University of South Florida, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fenway Community Health, San Francisco Department of Public Health, University of North Carolina, Chapel Hill, The Children's Hospital at Montefiore (CHAM), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Brown University, RAIN, Inc.

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
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).
Detailed Description
COMPARE 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. In years 1-2 of the iTech grant, the investigators optimized and pilot tested using a similar study design and identical study outcomes, two distinct mobile apps called LYNX and MyChoices. Each app is designed to increase HIV testing and PrEP uptake among YMSM. In this study, the individual apps are being tested in this follow-on research study to evaluate for efficacy. YMSM will be randomized to receive either MyChoices, LYNX, or SOC. LYNX uses the Information-Motivation-Behavior Skills (IMB) model and is a highly interactive mobile app to promote accurate risk perception, increase HIV/STI testing, and linkage to PrEP. MyChoices is guided by the Social Cognitive Theory (SCT) model, is adapted from HealthMindr and developed using iterative feedback from youth refined to maximize acceptability among YMSM. It includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences to impact behavior change. The SOC includes information on HIV testing and PrEP with the provision of referrals to local HIV/STI testing and PrEP resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
Keywords
PrEP, HIV Testing, Sexually Transmitted Infections, 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
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LYNX
Arm Type
Experimental
Arm Description
LYNX is developed using IMB model and engages youth through entering sexual diary data, earning badges, and calculating a personalized sexual protection (Sex Pro) score, which informs and motivates youth around HIV/STI testing and PrEP uptake. Behavioral skills are built through HIV/STI testing reminders, presenting options for home HIV testing and/or linkage to nearby testing services, and access to an online chat with support for HIV/STI testing and PrEP referral.
Arm Title
MyChoices
Arm Type
Experimental
Arm Description
MyChoices is adapted from an app for adult MSM, HealthMindr, developed using SCT. The app aims to increase HIV testing and PrEP uptake by increasing self- regulation, self-reflection, and self-efficacy around HIV testing and PrEP uptake. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos and infographics as well as "Help me Choose," "Ordering," and geofencing functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Provision of referrals to local HIV/STI testing and PrEP resources.
Intervention Type
Behavioral
Intervention Name(s)
LYNX
Intervention Description
Access to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature.
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
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Description
Proportion who complete >= 1 HIV test
Time Frame
6 months post baseline
Title
Efficacy for PrEP uptake: Proportion who uptake PrEP
Description
Proportion who uptake PrEP
Time Frame
6 months post baseline
Title
Efficacy for STI testing: Proportion who complete >=1 STI test
Description
Proportion who complete >=1 STI test
Time Frame
6 months post baseline
Secondary Outcome Measure Information:
Title
Efficacy for HIV testing: Proportion who complete >= 1 HIV test
Description
Proportion who complete >= 1 HIV test
Time Frame
12 months post baseline
Title
Efficacy for PrEP uptake: Proportion who uptake PrEP
Description
Proportion who uptake PrEP
Time Frame
12 months post baseline
Title
Efficacy for STI testing: Proportion who complete >=1 STI test
Description
Proportion who complete >=1 STI test
Time Frame
12 months post baseline

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender men
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 15 to 29 years. Assigned male sex at birth and male identified. Self-report being HIV uninfected or HIV status-unknown at screening. Self-report having not had an HIV test in the past 3 months. Self-report not currently taking PrEP. Self-report at least one episode of anal intercourse with a male or transfemale partner during the last 12 months. Able to understand, read, and speak English. Owns or leases a phone with Android platform or iOS platform, has an active data plan Has phone setting in English or Spanish, or willing to use an English or Spanish phone setting over the course of the study (Spanish setting is only for bilingual participants who speak both English and Spanish fluently) Willing and able to attend an in-person baseline study visit in one of the study site areas, or willing to attend a remote online baseline study visit Exclusion Criteria: Currently enrolled in another HIV intervention study. Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product. Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies 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. Not willing and/or not able to download the MyChoices and LYNX apps onto their phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Y Liu, MD, MPH
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katie B Biello, PhD, MPH
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida, Infectious Diseases
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
PRISM Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ayar @ Core
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Fenway Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Children's Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
RAIN, Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28202
Country
United States
Facility Name
Adolescent Initiative at Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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.

Learn more about this trial

Comparison of Men's Prevention Apps to Research Efficacy

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