NCT03177512

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 11, 2017

Results QC Date

October 28, 2020

Last Update Submit

April 19, 2021

Conditions

HIVSexually Transmitted DiseasesRisk ReductionPre-Exposure Prophylaxis

Keywords

PrEPHIV TestingSTI TestingMobile appTechnologyYoung men who have sex with men

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Frequency of App Use

    6 months

  • Number of Participants Using Different Parts of the App

    6 months

  • Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube

    6 months

  • Number of Participants Reporting HIV Testing Over 6 Months

    6 months

  • PrEP Uptake as Measured by Self Report

    6 months

Study Arms (2)

LYNX Mobile App

EXPERIMENTAL
Behavioral: LYNX Mobile App

Control

NO INTERVENTION

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

Interventions

LYNX Mobile AppBEHAVIORAL

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

LYNX Mobile App

Eligibility Criteria

Age15 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender male
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Florida, Department of Pediatrics

Tampa, Florida, 33606, United States

Location

The CORE Center, Cook County Health and Hospitals System

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • 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.

    PMID: 40440084DERIVED

  • 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.

    PMID: 30681964DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Albert Liu
Organization
Bridge HIV, San Francisco Department of Public Health
albert.liu@sfdph.org
628-217-7408

Study Officials

  • 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 CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Director

Study Record Dates

First Submitted

April 11, 2017

First Posted

June 6, 2017

Study Start

October 25, 2018

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

May 11, 2021

Results First Posted

May 11, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)