Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 15 Years and 24 Years
Eligible Genders
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 15 to 24 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.
  • Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months.
  • Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:
  • at least one episode of condomless anal intercourse with an HIV-infected or unknown HIV status male or transfemale partner during the last 6 months; or
  • anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or
  • exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
  • sex with a male or transfemale partner and has had an STI during the last 6 months.
  • Able to understand, read, and speak English.
  • Owns or leases a phone with Android platform or iOS platform, has an active data plan
  • Willing and able to attend an in-person baseline study visit in one of the study site areas

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LYNX
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
    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.
Experimental
MyChoices
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
    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.
No Intervention
Standard of Care
Provision of referrals to local HIV/STI testing and PrEP resources.

Recruiting Locations

Montefiore Children's Hospital
Bronx, New York 10467
Contact:
Donna Futterman, MD
718-882-0232

More Details

Status
Recruiting
Sponsor
Public Health Foundation Enterprises, Inc.

Study Contact

Albert Y Liu, MD, MPH
415-437-7408
albert.liu@sfdph.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.