- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177512
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
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 Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33606
- University of South Florida, Department of Pediatrics
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- The CORE Center, Cook County Health and Hospitals System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of App Use
Time Frame: 6 months
|
Number of login sessions
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Number of Participants Reporting HIV Testing Over 6 Months
Time Frame: 6 months
|
Self-report HIV testing during 6 month study
|
6 months
|
PrEP Uptake as Measured by Self Report
Time Frame: 6 months
|
Self-report of PrEP use
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-21876
- U19HD089881 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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