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

Not Applicable

Completed

• Conditions: HIV; Risk Reduction; Sexually Transmitted Diseases; Pre-Exposure Prophylaxis
• Interventions: Behavioral: LYNX Mobile App

• Registration Number: NCT03177512
• Lead Sponsor: Public Health Foundation Enterprises, Inc.

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.

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Study Start: 2018-10-25
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Results First Submitted: 2020-10-28
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Results First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYNX Mobile App	LYNX Mobile App	-

Primary Outcome Measures

Name	Time	Method
Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point	3 months	Opened the app at least once by Month 3 time point
Acceptability	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of South Florida, Department of Pediatrics; 🇺🇸 Tampa, Florida, United States

The CORE Center, Cook County Health and Hospitals System; 🇺🇸 Chicago, Illinois, United States