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Trial record 1 of 1 for:    COMPARE LYNX MyChoices | HIV/AIDS
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Comparison of Men's Prevention Apps to Research Efficacy (COMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965221
Recruitment Status : Active, not recruiting
First Posted : May 28, 2019
Last Update Posted : April 3, 2020
Sponsor:
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
Information provided by (Responsible Party):
Albert Liu, Public Health Foundation Enterprises, Inc.

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).

Condition or disease Intervention/treatment Phase
HIV/AIDS Sexually Transmitted Diseases Pre-exposure Prophylaxis Risk Reduction Behavioral: LYNX Behavioral: MyChoices Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Men's Prevention Apps to Research Efficacy
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: LYNX
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.
Behavioral: LYNX
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.

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



Primary Outcome Measures :
  1. Efficacy for HIV testing: Proportion who complete >= 1 HIV test [ Time Frame: 12 months post baseline ]
    Proportion who complete >= 1 HIV test

  2. Efficacy for PrEP uptake: Proportion who uptake PrEP [ Time Frame: 12 months post baseline ]
    Proportion who uptake PrEP

  3. Efficacy for STI testing: Proportion who complete >=1 STI test [ Time Frame: 12 months post baseline ]
    Proportion who complete >=1 STI test


Secondary Outcome Measures :
  1. Frequency of HIV testing [ Time Frame: 12 months post baseline ]
    Number of HIV tests completed

  2. Frequency of STI testing [ Time Frame: 12 months post baseline ]
    Number of STI tests completed

  3. Level of PrEP interest in the study population [ Time Frame: 3, 6, 12 months post baseline ]
    Interest in starting PrEP, by participant self-report

  4. Sexual behavior [ Time Frame: 3, 6, 12 months post baseline ]
    Frequency of condomless anal sex

  5. Frequency of use of app components [ Time Frame: ongoing over 12 months post baseline ]
    App usage data

  6. App content and functionalities most utilized [ Time Frame: ongoing over 12 months post baseline ]
    App usage data

  7. App content and functionalities least utilized [ Time Frame: ongoing over 12 months post baseline ]
    App usage data

  8. Social Cognitive Theory (SCT) model constructs for HIV/STI testing and PrEP uptake, including self regulation, self-efficacy and environmental influences [ Time Frame: 3, 6, 12 months post baseline ]
    Combined analysis of questionnaires regarding HIV testing and PrEP uptake, self-regulation, self-efficacy, and environmental influences

  9. Information, Motivation, Behavior (IMB) model constructs for HIV/STI testing and PrEP uptake [ Time Frame: 3, 6, 12 months post baseline ]
    Combined analysis of questionnaires regarding HIV testing and PrEP knowledge, motivations, and behavioral skills



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender men
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 15 to 24 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.
  • 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.
  • Able to understand, read, and speak English.
  • Owns or leases a phone with Android platform or iOS platform, has an active data plan
  • Willing and able to attend an in-person baseline study visit in one of the study site areas

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965221


Locations
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United States, Florida
University of South Florida, Infectious Diseases
Tampa, Florida, United States, 33606
United States, Georgia
PRISM Health
Atlanta, Georgia, United States, 30322
United States, Illinois
Ayar @ Core
Chicago, Illinois, United States, 60612
United States, Massachusetts
Fenway Health Center
Boston, Massachusetts, United States, 02215
United States, New York
Montefiore Children's Hospital
Bronx, New York, United States, 10467
United States, Pennsylvania
Adolescent Initiative at Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
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
Investigators
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Principal Investigator: Albert Y Liu, MD, MPH San Francisco Department of Public Health
Principal Investigator: Katie B Biello, PhD, MPH Brown University
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Responsible Party: Albert Liu, Director, Clinical Research, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03965221    
Other Study ID Numbers: 19-0260
5U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
PrEP
HIV Testing
Sexually Transmitted Infections
Mobile app
Young men who have sex with men
Technology
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Infection