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Completed

NCT Number: NCT03177512

LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing 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).

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Key information

Age range

15 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida, Department of Pediatrics, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LYNX Mobile App

Behavioral

Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Public Health Foundation Enterprises, Inc.

Other

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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2017
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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