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| ID | Type | Description | Link |
|---|---|---|---|
| U19HD089881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cook County Health & Hospitals System | OTHER |
| Duke University | OTHER |
| Emory University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYNX Mobile App | Experimental |
| |
| Control | No Intervention | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYNX Mobile App | Behavioral | Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features. |
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| 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 |
| 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 |
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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:
Exclusion Criteria:
Cisgender male
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida, Department of Pediatrics | Tampa | Florida | 33606 | United States | ||
| The CORE Center, Cook County Health and Hospitals System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40440084 | Derived | 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. | |
| 30681964 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LYNX Mobile App | 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. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2018 |
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| NIH |
| San Francisco Department of Public Health | OTHER_GOV |
| University of California, San Francisco | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| University of South Florida | OTHER |
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| 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 |
| Chicago |
| Illinois |
| 60612 |
| United States |
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LYNX Mobile App | 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. |
| BG001 | Control | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants in the LYNX Mobile App arm who completed assessment at month 3. Two participants answered "Declined to answer" - SUS was calculated out of 32 complete responses. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Primary | 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 | Feasibility was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Frequency of App Use | Number of login sessions | Frequency of app use was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator. | Posted | Mean | Standard Deviation | Number of login sessions | 6 months |
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| Secondary | Number of Participants Using Different Parts of the App | Use of each app component based on paradata from the mobile app | Analysis only included participants in the intervention arm. One participant was missing from the paradata and not included in the denominator. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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 | Only includes participants in the intervention arm, as home test kits could only be ordered through the app for participants in the LYNX mobile app arm | Posted | Number | participants | 6 months |
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| Secondary | Number of Participants Reporting HIV Testing Over 6 Months | Self-report HIV testing during 6 month study | Participants analyzed included those who had completed at least one follow-up survey | Posted | Count of Participants | Participants | 6 months |
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| Secondary | PrEP Uptake as Measured by Self Report | Self-report of PrEP use | Participants analyzed included those who completed at least one follow-up visit | Posted | Count of Participants | Participants | 6 months |
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Adverse event data was collected throughout the duration of the 6 month trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LYNX Mobile App | 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | Control | Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert Liu | Bridge HIV, San Francisco Department of Public Health | 628-217-7408 | albert.liu@sfdph.org |
| Oct 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| White |
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| Other/multiple |
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| Declined to answer |
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