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Trial record 1 of 1 for:    NCT03177512
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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

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ClinicalTrials.gov Identifier: NCT03177512
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : December 16, 2019
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.

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE June 6, 2017
Last Update Posted Date December 16, 2019
Actual Study Start Date  ICMJE October 25, 2018
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • Acceptability [ Time Frame: 6 months ]
    System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app.
  • Feasibility [ Time Frame: 6 months ]
    Frequency of logins, use of LYNX app components
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • Frequency of app use [ Time Frame: 6 months ]
    Usage data
  • Duration of app use [ Time Frame: 6 months ]
    Usage data
  • Analysis of mobile application data showing what parts were used in order to assess what app content and functionalities are most and least utilized. [ Time Frame: 6 months ]
    Usage data
  • Number of HIV/STI home testing kits, condoms and lube requested [ Time Frame: 6 months ]
    Combined usage data
  • Preliminary efficacy: HIV testing frequency [ Time Frame: 6 months ]
    Submitted evidence of HIV test results; Self-report
  • Preliminary efficacy: STI testing frequency [ Time Frame: 6 months ]
    Submitted evidence of STI test results; Self-report
  • PrEP interest and uptake as measured by self report [ Time Frame: 6 months ]
    Self-report of linkage to PrEP and PrEP utilization (aggregate analysis of questionnaire and phone interview)
  • Sexual and drug use behaviors, as measured via questionnaire [ Time Frame: 6 months ]
    Self-report by questionnaire
  • Utilization of health care, by self-report via questionnaires and interviews [ Time Frame: 6 months ]
    Self-reported questionnaire
  • Information, Motivation, Behavior (IMB) model constructs for HIV/STI testing [ Time Frame: 6 months ]
    Summary data from from questionnaire regarding HIV/STI testing knowledge, motivations, and behavioral skills
  • Information, Motivation, Behavior (IMB) model constructs for PrEP uptake [ Time Frame: 6 months ]
    Summary data from from questionnaire regarding PrEP knowledge, motivations, and behavioral skills
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Sexually Transmitted Diseases
  • Risk Reduction
  • Pre-Exposure Prophylaxis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: LYNX Mobile App
    Intervention: Behavioral: LYNX Mobile App
  • No Intervention: Control
    Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2019)
61
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2017)
60
Actual Study Completion Date  ICMJE November 18, 2019
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Cisgender male
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03177512
Other Study ID Numbers  ICMJE 17-21876
U19HD089881 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Albert Liu, Public Health Foundation Enterprises, Inc.
Study Sponsor  ICMJE Public Health Foundation Enterprises, Inc.
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Public Health Foundation Enterprises, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP