Comparison of Men's Prevention Apps to Research Efficacy (COMPARE)

Public Health Foundation Enterprises, Inc.

Status: Completed

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

Treatments: Behavioral: MyChoices; Behavioral: LYNX

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT03965221

19-0260

5U19HD089881 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 381 patients

Sex: Male

Ages: 15 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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381 participants in 3 patient groups

LYNX

Experimental group

Description:

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.

Treatment:

Behavioral: LYNX

MyChoices

Experimental group

Description:

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.

Treatment:

Behavioral: MyChoices

Standard of Care

No Intervention group

Description:

Provision of referrals to local HIV/STI testing and PrEP resources.