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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177512
• Other study ID #: 17-21876
• Secondary ID: U19HD089881
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: November 18, 2019

Study information

• Verified date: April 2021
• Source: Public Health Foundation Enterprises, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Pre-Exposure Prophylaxis
• Risk Reduction
• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	The CORE Center, Cook County Health and Hospitals System	Chicago	Illinois
United States	University of South Florida, Department of Pediatrics	Tampa	Florida

Sponsors (9)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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	3 months
Secondary	Frequency of App Use	Number of login sessions	6 months
Secondary	Number of Participants Using Different Parts of the App	Use of each app component based on paradata from the mobile app	6 months
Secondary	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	6 months
Secondary	Number of Participants Reporting HIV Testing Over 6 Months	Self-report HIV testing during 6 month study	6 months
Secondary	PrEP Uptake as Measured by Self Report	Self-report of PrEP use	6 months