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Completed

NCT Number: NCT03965221

Comparison of Men's Prevention Apps to Research Efficacy

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LYNX

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Efficacy for HIV testing: Proportion who complete >= 1 HIV test

    Time frame: 6 months post baseline

    Proportion who complete >= 1 HIV test

  2. Efficacy for PrEP uptake: Proportion who uptake PrEP

    Time frame: 6 months post baseline

    Proportion who uptake PrEP

  3. Efficacy for STI testing: Proportion who complete >=1 STI test

    Time frame: 6 months post baseline

    Proportion who complete >=1 STI test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Public Health Foundation Enterprises, Inc.

Other

Collaborators

  • Adolescent Trials Network for HIV/AIDS Interventions
  • Adolescent and Young Adult Research (AYAR), CORE Center
  • Baylor College of Medicine
  • Brown University
  • Children's Hospital at Montefiore
  • 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
  • University of North Carolina, Chapel Hill
  • University of South Florida

Registry information

Acronym: COMPARE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2019
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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