Comparison of Men's Prevention Apps to Research Efficacy

Study Overview
=================
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.

Official Title
-----------------
Comparison of Men's Prevention Apps to Research Efficacy

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

Intervention / Treatment
-----------------
* Behavioral: LYNX
* Behavioral: MyChoices


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LYNX<br>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<br>* 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.<br>|
| Experimental: MyChoices<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>Provision of referrals to local HIV/STI testing and PrEP resources. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy for HIV testing: Proportion who complete >= 1 HIV test | Proportion who complete >= 1 HIV test | 6 months post baseline | 
| Efficacy for PrEP uptake: Proportion who uptake PrEP | Proportion who uptake PrEP | 6 months post baseline | 
| Efficacy for STI testing: Proportion who complete >=1 STI test | Proportion who complete >=1 STI test | 6 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy for HIV testing: Proportion who complete >= 1 HIV test | Proportion who complete >= 1 HIV test | 12 months post baseline | 
| Efficacy for PrEP uptake: Proportion who uptake PrEP | Proportion who uptake PrEP | 12 months post baseline | 
| Efficacy for STI testing: Proportion who complete >=1 STI test | Proportion who complete >=1 STI test | 12 months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PrEP, HIV Testing, Sexually Transmitted Infections, Mobile app, Young men who have sex with men, Technology