Clinical trial NCT03177512: LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
Official title: LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing and Pre-exposure Prophylaxis (PrEP) for Young Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Diseases
Risk Reduction
Pre-Exposure Prophylaxis
Keywords: PrEP
HIV Testing
STI Testing
Mobile app
Technology
Young men who have sex with men
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: Cook County Health & Hospitals System
name: Duke University
name: Emory University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: San Francisco Department of Public Health
name: University of California, San Francisco
name: University of North Carolina, Chapel Hill
name: University of South Florida
First posted: 2017-06-06
Enrollment: 61
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men who have sex with men (YMSM).

Detailed description: Using the Information-Motivation-Behavior Skills (IMB) model, we have developed LYNX, a highly interactive mobile app to promote accurate risk perception and increase HIV/STI testing and linkage to PrEP among young men who have sex with men (YMSM). Key components of the app include Sex Pro (a personalized HIV risk score), a sex diary to facilitate accurate data collection; HIV/STI testing information and reminders; access to home HIV/STI testing options; a geospatial-based locator of HIV/STI testing sites and PrEP clinics; PrEP information and videos; and online PrEP navigation.

This study 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.

Eligibility criteria: Inclusion Criteria:

* No HIV test in the past 3 months (self-reported).
* Not known to be HIV-infected (self-reported).
* Not currently taking PrEP (self-reported).
* Owns an Apple operating system (iOS) or Android mobile phone and willing and able to download the LYNX app onto their phone.
* Willing and able to attend an in-person baseline visit in the Tampa or Chicago area.
* Able to understand, read, and speak English.
* 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:

  1. at least one episode of condomless anal sex with an HIV-positive or unknown HIV status male or transfemale partner during the last 6 months; or
  2. Anal sex with 2 or more male and/or transfemale partners during the last 6 months; or
  3. Exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
  4. Sex with a male or transfemale partner and has had an STI during the last 6 months.

Exclusion Criteria:

* Currently enrolled in another HIV intervention study
* Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product
* Enrollment in an earlier phase of LYNX study
* 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.

Primary outcomes:
measure: Acceptability
timeFrame: 3 months
measure: Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point
timeFrame: 3 months
Secondary outcomes:
measure: Frequency of App Use
timeFrame: 6 months
measure: Number of Participants Using Different Parts of the App
timeFrame: 6 months
measure: Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube
timeFrame: 6 months
measure: Number of Participants Reporting HIV Testing Over 6 Months
timeFrame: 6 months
measure: PrEP Uptake as Measured by Self Report
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida, Department of Pediatrics
state: Florida
city: Chicago
country: United States
facility: The CORE Center, Cook County Health and Hospitals System
state: Illinois
Study officials:
affiliation: Bridge HIV, San Francisco Department of Public Health
name: Albert Liu, M.D., MPH
role: STUDY_CHAIR
affiliation: Bridge HIV, San Francisco Department of Public Health
name: Hyman Scott, M.D., MPH
role: STUDY_CHAIR
References:
citation: Liu A, Coleman K, Bojan K, Serrano PA, Oyedele T, Garcia A, Enriquez-Bruce E, Emmanuel P, Jones J, Sullivan P, Hightow-Weidman L, Buchbinder S, Scott H. Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e10659. doi: 10.2196/10659.