Comparison of Men's Prevention Apps to Research Efficacy

HIV/AIDS Clinical Trial

— COMPARE  

Official title:

Comparison of Men's Prevention Apps to Research Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965221
• Other study ID #: 19-0260
• Secondary ID: 5U19HD089881
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Public Health Foundation Enterprises, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• Pre-exposure Prophylaxis
• Risk Reduction
• Sexually Transmitted Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	PRISM Health	Atlanta	Georgia
United States	Fenway Health Center	Boston	Massachusetts
United States	Montefiore Children's Hospital	Bronx	New York
United States	RAIN, Inc	Charlotte	North Carolina
United States	Ayar @ Core	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Adolescent Initiative at Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of South Florida, Infectious Diseases	Tampa	Florida

Sponsors (16)

Lead Sponsor

Collaborator

Public Health Foundation Enterprises, Inc.

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy for HIV testing: Proportion who complete >= 1 HIV test	Proportion who complete >= 1 HIV test	6 months post baseline
Primary	Efficacy for PrEP uptake: Proportion who uptake PrEP	Proportion who uptake PrEP	6 months post baseline
Primary	Efficacy for STI testing: Proportion who complete >=1 STI test	Proportion who complete >=1 STI test	6 months post baseline
Secondary	Efficacy for HIV testing: Proportion who complete >= 1 HIV test	Proportion who complete >= 1 HIV test	12 months post baseline
Secondary	Efficacy for PrEP uptake: Proportion who uptake PrEP	Proportion who uptake PrEP	12 months post baseline
Secondary	Efficacy for STI testing: Proportion who complete >=1 STI test	Proportion who complete >=1 STI test	12 months post baseline