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

• ClinicalTrials.gov Identifier: NCT03965221
• Recruitment Status: Active, not recruiting
• First Posted: May 28, 2019
• Last Update Posted: April 3, 2020
• 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
• 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

• 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

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 :

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

Eligibility Criteria

• 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

Locations

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

• Principal Investigator: Albert Y Liu, MD, MPH; San Francisco Department of Public Health
• Principal Investigator: Katie B Biello, PhD, MPH; Brown University

More Information

• 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
• 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.

• 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:

Sexually Transmitted Diseases; Virus Diseases; Infection