search
Back to results

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

Primary Purpose

HIV, Sexually Transmitted Diseases, Risk Reduction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LYNX Mobile App
Sponsored by
Public Health Foundation Enterprises, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring PrEP, HIV Testing, STI Testing, Mobile app, Technology, Young men who have sex with men

Eligibility Criteria

15 Years - 24 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of South Florida, Department of Pediatrics
  • The CORE Center, Cook County Health and Hospitals System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LYNX Mobile App

Control

Arm Description

Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Frequency of App Use
Number of login sessions
Number of Participants Using Different Parts of the App
Use of each app component based on paradata from the mobile app
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
Number of Participants Reporting HIV Testing Over 6 Months
Self-report HIV testing during 6 month study
PrEP Uptake as Measured by Self Report
Self-report of PrEP use

Full Information

First Posted
April 11, 2017
Last Updated
April 19, 2021
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Cook County Health & Hospitals System, Duke University, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Francisco Department of Public Health, University of California, San Francisco, University of North Carolina, Chapel Hill, University of South Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03177512
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Cook County Health & Hospitals System, Duke University, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Francisco Department of Public Health, University of California, San Francisco, University of North Carolina, Chapel Hill, University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LYNX Mobile App
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Intervention Type
Behavioral
Intervention Name(s)
LYNX Mobile App
Intervention Description
Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
3 months
Title
Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point
Description
Opened the app at least once by Month 3 time point
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frequency of App Use
Description
Number of login sessions
Time Frame
6 months
Title
Number of Participants Using Different Parts of the App
Description
Use of each app component based on paradata from the mobile app
Time Frame
6 months
Title
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube
Description
Number of Participants who ordered HIV/STI home testing kits, condom and lube
Time Frame
6 months
Title
Number of Participants Reporting HIV Testing Over 6 Months
Description
Self-report HIV testing during 6 month study
Time Frame
6 months
Title
PrEP Uptake as Measured by Self Report
Description
Self-report of PrEP use
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 Anal sex with 2 or more male and/or transfemale 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Liu, M.D., MPH
Organizational Affiliation
Bridge HIV, San Francisco Department of Public Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hyman Scott, M.D., MPH
Organizational Affiliation
Bridge HIV, San Francisco Department of Public Health
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Florida, Department of Pediatrics
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
The CORE Center, Cook County Health and Hospitals System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30681964
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs