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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03177512
Recruitment Status : Completed
First Posted : June 6, 2017
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
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
Information provided by (Responsible Party):
Albert Liu, Public Health Foundation Enterprises, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Sexually Transmitted Diseases Risk Reduction Pre-Exposure Prophylaxis Behavioral: LYNX Mobile App Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability [ Time Frame: 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.

  2. Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point [ Time Frame: 3 months ]
    Opened the app at least once by Month 3 time point


Secondary Outcome Measures :
  1. Frequency of App Use [ Time Frame: 6 months ]
    Number of login sessions

  2. Number of Participants Using Different Parts of the App [ Time Frame: 6 months ]
    Use of each app component based on paradata from the mobile app

  3. Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube [ Time Frame: 6 months ]
    Number of Participants who ordered HIV/STI home testing kits, condom and lube

  4. Number of Participants Reporting HIV Testing Over 6 Months [ Time Frame: 6 months ]
    Self-report HIV testing during 6 month study

  5. PrEP Uptake as Measured by Self Report [ Time Frame: 6 months ]
    Self-report of PrEP use


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177512


Locations
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United States, Florida
University of South Florida, Department of Pediatrics
Tampa, Florida, United States, 33606
United States, Illinois
The CORE Center, Cook County Health and Hospitals System
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
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
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] November 28, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03177512    
Other Study ID Numbers: 17-21876
U19HD089881 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2017    Key Record Dates
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
PrEP
HIV Testing
STI Testing
 Mobile app
Technology
Young men who have sex with men
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes