LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
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ClinicalTrials.gov Identifier: NCT03177512 |
Recruitment Status :
Completed
First Posted : June 6, 2017
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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HIV Sexually Transmitted Diseases Risk Reduction Pre-Exposure Prophylaxis | Behavioral: LYNX Mobile App | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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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.
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- 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.
- 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
- Frequency of App Use [ Time Frame: 6 months ]Number of login sessions
- 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
- 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
- Number of Participants Reporting HIV Testing Over 6 Months [ Time Frame: 6 months ]Self-report HIV testing during 6 month study
- PrEP Uptake as Measured by Self Report [ Time Frame: 6 months ]Self-report of PrEP use

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177512
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 |
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 |
Documents provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
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 Key Record Dates |
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 |
PrEP HIV Testing STI Testing |
Mobile app Technology Young men who have sex with men |
Sexually Transmitted Diseases Communicable Diseases Infections Disease Attributes Pathologic Processes |