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)

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ClinicalTrials.gov Identifier: NCT03965221

Recruitment Status : Recruiting

First Posted : May 28, 2019

Last Update Posted : October 12, 2021

See Contacts and Locations

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.

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).

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	450 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 :	May 2022
Estimated Study Completion Date :	September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

Efficacy for HIV testing: Proportion who complete >= 1 HIV test [ Time Frame: 12 months post baseline ]
Proportion who complete >= 1 HIV test
Efficacy for PrEP uptake: Proportion who uptake PrEP [ Time Frame: 12 months post baseline ]
Proportion who uptake PrEP
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 :

Frequency of HIV testing [ Time Frame: 12 months post baseline ]
Number of HIV tests completed
Frequency of STI testing [ Time Frame: 12 months post baseline ]
Number of STI tests completed
Level of PrEP interest in the study population [ Time Frame: 3, 6, 12 months post baseline ]
Interest in starting PrEP, by participant self-report
Sexual behavior [ Time Frame: 3, 6, 12 months post baseline ]
Frequency of condomless anal sex
Frequency of use of app components [ Time Frame: ongoing over 12 months post baseline ]
App usage data
App content and functionalities most utilized [ Time Frame: ongoing over 12 months post baseline ]
App usage data
App content and functionalities least utilized [ Time Frame: ongoing over 12 months post baseline ]
App usage data
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
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

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

Contacts

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Contact: Albert Y Liu, MD, MPH	415-437-7408	albert.liu@sfdph.org
Contact: Katie B Biello, PhD, MPH	401-863-3082	Katie_Biello@brown.edu

Locations

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United States, Florida
University of South Florida, Infectious Diseases	Recruiting
Tampa, Florida, United States, 33606
Contact: Patricia Emmanuel, MD 813-844-4187
Principal Investigator: Patricia Emmanuel, MD
United States, Georgia
PRISM Health	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, DVM, PhD 404-727-3038 pssuli@emory.edu
Principal Investigator: Patrick Sullivan, DVM, PhD
United States, Illinois
Ayar @ Core	Recruiting
Chicago, Illinois, United States, 60612
Contact: Temitope Oyedele, MD 312-572-4500
Principal Investigator: Temitope Oyedele, MD
United States, Massachusetts
Fenway Health Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Julian Dormitzer, RN 617-927-6309 jdormitzer@fenwayhealth.org
Principal Investigator: Kenneth H. Mayer, MD
United States, New York
Montefiore Children's Hospital	Recruiting
Bronx, New York, United States, 10467
Contact: Donna Futterman, MD 718-882-0232
Principal Investigator: Donna Futterman, MD
United States, Pennsylvania
Adolescent Initiative at Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marne Castillo, MEd 215-590-3800
Principal Investigator: Marne Castillo, MEd
United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Mary Paul, MD 832-822-1038
Principal Investigator: Mary Paul, MD

Sponsors and Collaborators

Public Health Foundation Enterprises, Inc.