Comparison of Men's Prevention Apps to Research Efficacy

Public Health Foundation Enterprises, Inc.381 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

381

Conditions

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

Interventions

LYNXBEHAVIORAL

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.

MyChoicesBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 15 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

University of South Florida, Infectious Diseases

Tampa, Florida, United States

PRISM Health

Atlanta, Georgia, United States

Ayar @ Core

Chicago, Illinois, United States

Fenway Health Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Proportion who complete \>= 1 HIV test

Time frame: 6 months post baseline

Efficacy for PrEP uptake: Proportion who uptake PrEP

Proportion who uptake PrEP

Time frame: 6 months post baseline

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

Proportion who complete \>=1 STI test

Time frame: 6 months post baseline

Secondary Outcomes

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

Proportion who complete \>= 1 HIV test

Time frame: 12 months post baseline

Efficacy for PrEP uptake: Proportion who uptake PrEP

Proportion who uptake PrEP

Time frame: 12 months post baseline

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

Proportion who complete \>=1 STI test

Time frame: 12 months post baseline

Data from ClinicalTrials.gov

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