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

NCT ID: NCT03177512

Last Updated: 2021-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-11-18

Brief Summary

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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

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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.

Conditions

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HIV Sexually Transmitted Diseases Risk Reduction Pre-Exposure Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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LYNX Mobile App

Group Type EXPERIMENTAL

LYNX Mobile App

Intervention Type BEHAVIORAL

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

Control

Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cook County Health & Hospitals System

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

Public Health Foundation Enterprises, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Albert Liu

Clinical Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Liu, M.D., MPH

Role: STUDY_CHAIR

Bridge HIV, San Francisco Department of Public Health

Hyman Scott, M.D., MPH

Role: STUDY_CHAIR

Bridge HIV, San Francisco Department of Public Health

Locations

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University of South Florida, Department of Pediatrics

Tampa, Florida, United States

Site Status

The CORE Center, Cook County Health and Hospitals System

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Liu AY, Torres TS, Alleyne CD, Vinson J, Bojan K, Serrano PA, Oyedele T, Garcia A, Enriquez-Bruce E, Emmanuel P, Jones J, Muessig KE, Buchbinder SP, Sullivan P, Hightow-Weidman LB, Scott H. Developing a Novel Mobile App to Support HIV Testing and Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Formative and Technical Pilot Study. JMIR Hum Factors. 2025 May 29;12:e62830. doi: 10.2196/62830.

Reference Type DERIVED
PMID: 40440084 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30681964 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U19HD089881

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-21876

Identifier Type: -

Identifier Source: org_study_id

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