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

• 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: Public Health Foundation Enterprises, Inc.
• 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

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• 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

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

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.

• 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
• 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

• 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:

Sexually Transmitted Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes