COMPARE: Comparison of Men's Prevention Apps to Research Efficacy

• Sponsor: Public Health Foundation Enterprises, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT03965221
• Collaborator: Adolescent Trials Network for HIV/AIDS Interventions (Other), Adolescent and Young Adult Research (AYAR), CORE Center (Other), Children's Hospital of Philadelphia (Other), Baylor College of Medicine (Other), University of South Florida (Other), Emory University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Fenway Community Health (Other), San Francisco Department of Public Health (Other), University of North Carolina, Chapel Hill (Other), The Children's Hospital at Montefiore (CHAM) (Other), National Institute on Drug Abuse (NIDA) (NIH), National Institute of Mental Health (NIMH) (NIH), Brown University (Other), RAIN, Inc. (Other)
• Enrollment: 381
• Locations: 8
• Arms: 3
• Actual Duration (Months): 31.5
• Patients Per Site: 47.6
• Patients Per Site Per Month: 1.5

Study Details

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	N/A

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
• Actual Enrollment: 381 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: Oct 14, 2019
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

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 [6 months post baseline]

   Proportion who complete >= 1 HIV test

2. Efficacy for PrEP uptake: Proportion who uptake PrEP [6 months post baseline]

   Proportion who uptake PrEP

3. Efficacy for STI testing: Proportion who complete >=1 STI test [6 months post baseline]

   Proportion who complete >=1 STI test

Secondary Outcome Measures

1. Efficacy for HIV testing: Proportion who complete >= 1 HIV test [12 months post baseline]

   Proportion who complete >= 1 HIV test

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

   Proportion who uptake PrEP

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

   Proportion who complete >=1 STI test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 29 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida, Infectious Diseases	Tampa	Florida	United States	33606
2	PRISM Health	Atlanta	Georgia	United States	30322
3	Ayar @ Core	Chicago	Illinois	United States	60612
4	Fenway Health Center	Boston	Massachusetts	United States	02215
5	Montefiore Children's Hospital	Bronx	New York	United States	10467
6	RAIN, Inc	Charlotte	North Carolina	United States	28202
7	Adolescent Initiative at Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
8	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
• RAIN, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Liu, Director, Clinical Research, Public Health Foundation Enterprises, Inc.
• ClinicalTrials.gov Identifier: NCT03965221
• Other Study ID Numbers: 19-0260; 5U19HD089881
• First Posted: May 28, 2019
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Albert Liu, Director, Clinical Research, 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

Study Results

No Results Posted as of Jul 28, 2022