Clinical trial NCT03965221: Comparison of Men's Prevention Apps to Research Efficacy
Official title: Comparison of Men's Prevention Apps to Research Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Sexually Transmitted Diseases
Pre-exposure Prophylaxis
Risk Reduction
Keywords: PrEP
HIV Testing
Sexually Transmitted Infections
Mobile app
Young men who have sex with men
Technology
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: Adolescent Trials Network for HIV/AIDS Interventions
name: Adolescent and Young Adult Research (AYAR), CORE Center
name: Children's Hospital of Philadelphia
name: Baylor College of Medicine
name: University of South Florida
name: Emory University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Fenway Community Health
name: San Francisco Department of Public Health
name: University of North Carolina, Chapel Hill
name: The Children's Hospital at Montefiore (CHAM)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: Brown University
name: RAIN, Inc.
First posted: 2019-05-28
Enrollment: 381
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy for HIV testing: Proportion who complete >= 1 HIV test
timeFrame: 6 months post baseline
measure: Efficacy for PrEP uptake: Proportion who uptake PrEP
timeFrame: 6 months post baseline
measure: Efficacy for STI testing: Proportion who complete >=1 STI test
timeFrame: 6 months post baseline
Secondary outcomes:
measure: Efficacy for HIV testing: Proportion who complete >= 1 HIV test
timeFrame: 12 months post baseline
measure: Efficacy for PrEP uptake: Proportion who uptake PrEP
timeFrame: 12 months post baseline
measure: Efficacy for STI testing: Proportion who complete >=1 STI test
timeFrame: 12 months post baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida, Infectious Diseases
state: Florida
city: Atlanta
country: United States
facility: PRISM Health
state: Georgia
city: Chicago
country: United States
facility: Ayar @ Core
state: Illinois
city: Boston
country: United States
facility: Fenway Health Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Children's Hospital
state: New York
city: Charlotte
country: United States
facility: RAIN, Inc
state: North Carolina
city: Philadelphia
country: United States
facility: Adolescent Initiative at Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: San Francisco Department of Public Health
name: Albert Y Liu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Katie B Biello, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: