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

Study Overview
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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.

Official Title
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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

Conditions
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HIV, Sexually Transmitted Diseases, Risk Reduction, Pre-Exposure Prophylaxis

Intervention / Treatment
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* Behavioral: LYNX Mobile App


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LYNX Mobile App<br> | Behavioral: LYNX Mobile App<br>* Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.<br>|
| No Intervention: Control<br>Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of App Use | Number of login sessions | 6 months | 
| Number of Participants Using Different Parts of the App | 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 | Number of Participants who ordered HIV/STI home testing kits, condom and lube | 6 months | 
| Number of Participants Reporting HIV Testing Over 6 Months | Self-report HIV testing during 6 month study | 6 months | 
| PrEP Uptake as Measured by Self Report | Self-report of PrEP use | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, HIV Testing, STI Testing, Mobile app, Technology, Young men who have sex with men