LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men

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

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).

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV; Risk Reduction; Pre-Exposure Prophylaxis
• Intervention / Treatment: Behavioral: LYNX Mobile App

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida, Department of Pediatrics
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The CORE Center, Cook County Health and Hospitals System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LYNX Mobile App	Behavioral: LYNX Mobile App; Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
No Intervention: Control; Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app. Range of scale is 0-100, with higher scores indicating higher acceptability.	3 months
Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point	Opened the app at least once by Month 3 time point	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of App Use	Number of login sessions	6 months
Number of Participants Using Different Parts of the App	Use of each app component based on paradata from the mobile app	6 months
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube	Number of Participants who ordered HIV/STI home testing kits, condom and lube	6 months
Number of Participants Reporting HIV Testing Over 6 Months	Self-report HIV testing during 6 month study	6 months
PrEP Uptake as Measured by Self Report	Self-report of PrEP use	6 months

Collaborators and Investigators

• Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of South Florida; Emory University; Duke University; University of California, San Francisco; University of North Carolina, Chapel Hill; San Francisco Department of Public Health; Cook County Health & Hospitals System
• Investigators: Study Chair: Albert Liu, M.D., MPH, Bridge HIV, San Francisco Department of Public Health; Study Chair: Hyman Scott, M.D., MPH, Bridge HIV, San Francisco Department of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PrEP; HIV Testing; Technology; Mobile app; Young men who have sex with men; STI Testing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 17-21876; U19HD089881 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No