HIVNCT03177512
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
A study testing LYNX Mobile App in people with HIV and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases, Risk Reduction
- What is being tested?
- LYNX Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2018to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The CORE Center, Cook County Health and Hospitals System
Chicago, Illinois, 60612
University of South Florida, Department of Pediatrics
Tampa, Florida, 33606
About this study
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
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).
Read the detailed description
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.
- Being tested
- LYNX Mobile App
- Keywords
- PrEP, HIV Testing, STI Testing, Mobile app, Technology, Young men who have sex with men
- Medical subject headings
- Sexually Transmitted Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYNX Mobile AppBehavioural
Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
| Study group | Role | What they receive |
|---|---|---|
| LYNX Mobile App | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Secondary outcomes (5)
Frequency of App Use
Number of login sessions
Measured: 6 months
Number of Participants Using Different Parts of the App
Use of each app component based on paradata from the mobile app
Measured: 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
Measured: 6 months
Number of Participants Reporting HIV Testing Over 6 Months
Self-report HIV testing during 6 month study
Measured: 6 months
PrEP Uptake as Measured by Self Report
Self-report of PrEP use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start25 Oct 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Cook County Health & Hospitals System, Duke University, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Francisco Department of Public Health, University of California, San Francisco, University of North Carolina, Chapel Hill, University of South Florida
- Responsible party
- Principal investigator, Albert Liu, Public Health Foundation Enterprises, Inc.
- Investigators
- Albert Liu, M.D., MPH, Study chair, Bridge HIV, San Francisco Department of Public HealthHyman Scott, M.D., MPH, Study chair, Bridge HIV, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177512
- Sponsor's protocol ID
- 17-21876
- Other IDs
- U19HD089881
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2017
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40440084Liu 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.
PubMed 30681964
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03177512
- Acronym / sponsor ID
- 17-21876
- Keywords
- PrEP, HIV Testing, STI Testing, Mobile app, Technology, Young men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- Cook County Health & Hospitals System, Duke University, Emory University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Francisco Department of Public Health, University of California, San Francisco, University of North Carolina, Chapel Hill, University of South Florida
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYNX Mobile AppAccess to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features. | Behavioural | LYNX Mobile App |
Primary outcome
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
5 secondary outcomes
Frequency of App Use
Time frame: 6 months
Number of Participants Using Different Parts of the App
Time frame: 6 months
Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube
Time frame: 6 months
Number of Participants Reporting HIV Testing Over 6 Months
Time frame: 6 months
PrEP Uptake as Measured by Self Report
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40440084Liu 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.
- Derived from this study: PubMed 30681964Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Liu, M.D., MPH study chair
Bridge HIV, San Francisco Department of Public Health
Hyman Scott, M.D., MPH study chair
Bridge HIV, San Francisco Department of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYNX Mobile App in people with HIV and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.