HIV PreventionLYNXNCT07599722
mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System
A study testing LYNX in people with HIV Prevention and Substance Use, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Substance Use
- What is being tested?
- LYNX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-report recent criminal legal involvement (past year);
- Self-identify as HIV-negative
- Endorse behaviors in the past 6 months indicating consideration of PrEP per the Center for Disease Control and Prevention's (CDC) risk indices
- Meet the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tools' criteria for identifying the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder
- Are conversant in English.
Who cannot join
- Being on Pre-exposure Prophylaxis (PrEP)
- Cognitive delays that would interfere with consent or participation
- Inability to provide contact information for >2 locator individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh, School of Public Health
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults
This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools.
The study will:
Read more
- Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services.
- Refine and test the updated program to make sure it works well and is easy to use.
- Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services.
The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.
- Conditions
- HIV Prevention, Substance Use
- Being tested
- LYNX, Standard of Care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYNXBehavioural
LYNX is an mHealth enhanced, adapted navigator program designed to refer and link young adults (18 to 29 years) impacted by the criminal legal system to services related to substance use and HIV.
Standard of CareBehavioural
Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community. Receives: Behavioral: Standard of Care |
| LYNX Intervention | Experimental | Project LYNX is a new program designed to help young adults involved in the criminal legal system (ages 18-29) get connected to substance use treatment and HIV-prevention services. Receives: Behavioral: LYNX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to substance use services
Substance use service linkage will be attendance at a substance use service appointment via self-report via the question: " Did you attend your first appointment with your substance use treatment provider?" Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Linkage to Pre-exposure Prophylaxis Services
Pre-exposure Prophylaxis (PrEP) linkage will be self-reported engagement in PrEP related services in the last month via the question " Have you received any PrEP-related services in the past [month/3 months]?" Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Secondary outcomes (12)
Pre-exposure Prophylaxis Referral
Pre-exposure Prophylaxis (PrEP) referral be reported via self-report via the question: "Has your navigator offered to connect you to PrEP services?" Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Time to Pre-exposure Prophylaxis Linkage
Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to Pre-exposure Prophylaxis (PrEP) services and the date they recorded the participant first attended a PrEP related appointment. The investigators will report the average number of days between the date of referral and first appointment attendance.
Measured: Time Frame: 4 month post-enrollment
Receipt of Pre-exposure Prophylaxis Prescription
Receipt of a Pre-exposure Prophylaxis (PrEP) prescription will be identified via self-report via the question "Have you received a prescription for PrEP?". Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Fill of Pre-exposure Prophylaxis Prescription
Fill of a Pre-exposure Prophylaxis (PrEP) prescription will be identified via self-report via the question: "Have you filled your PrEP prescription?" Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Pre-exposure Prophylaxis Initiation
Pre-exposure Prophylaxis (PrEP) initiation will be identified via self-report via the question: "Have you started to take PrEP?" Yes or No . The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Pre-exposure Prophylaxis Adherence
Pre-exposure Prophylaxis (PrEP) adherence will be identified via self-report via the question: "In the past 30 days, rate your ability to take your PrEP medications as prescribed?" Very often, Somewhat often, Often, Not very often, Never. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4-month post-enrollment
Pre-exposure Prophylaxis Persistence
Pre-exposure Prophylaxis (PrEP) persistence will be identified through self-report via the question: "Have you stopped taking PrEP?: Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4-month post-enrollment
Accepted Substance Use Service Referral
Accepted substance use treatment referral will be reported via self-report via the question: "Has your navigator offered to connect you to substance use services?" Yes or No. The investigators will report the number of participants that answered with each response option.
Measured: Time Frame: 4 month post-enrollment
Time to Substance Use Linkage
Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to substance use services and the date they recorded the participant first attended a substance use related appointment. The investigators will report the average number of days between the date of referral and first appointment attendance.
Measured: Time Frame: 4 month post-enrollment
Navigation Satisfaction Tool
The Navigation Satisfaction Tool (NAVSAT) includes twelve items that address client satisfaction with navigation services (e.g., How satisfied are you with the navigator's ability to listen and understand your concerns? How satisfied are you with the frequency of contact with the navigator?). Items are rated on a Likert scale from 1 (extremely dissatisfied / extremely unhelpful) to 7 (satisfied/ extremely satisfied). A total item score is calculated. Higher scores reflect greater navigator satisfaction. The investigators will report the mean and the standard deviation for the NAVSAT score.
Measured: Time Frame: 4-month post-enrollment
Client Intervention Satisfaction
The Study Participant Feedback Questionnaire (SPFQ) comprises 23-questions and is split into three brief, validated questionnaires capturing trial experience at baseline, mid-point, and end of the study. The majority of items use a 5-point Likert satisfaction response scale. Some questions use a yes/no scale. The SPFQ is not designed to produce a single composite score. Responses will be analyzed item by item and reported as frequency distributions for each individual question, by response.
Measured: Baseline, 1-month post enrollment, 3-months post-enrollment
Perceived Navigator Similarity
The Perceived Navigator Similarity scale consists of 10 items - 5 related to personal similarity and 5 related to ethnic similarity. Patients respond to each item using a 6-point Likert scale ranging from 0 (very different) to 5 (very similar). The investigators will calculate a total score by summing all items, with higher scores indicating greater perceived similarity.
Measured: Time Frame: 4-month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Emily Dauria, University of Pittsburgh
- Investigators
- Emily Dauria, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599722
- Sponsor's protocol ID
- STUDY22020053 (Aim 3)
- Other IDs
- 5R34DA057891-03
- Acronym
- LYNX
- Status last verified
- Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Results will be published by the investigators in academic journals.
Publications
Creasy SL, Sweet S, Myers JJ, Shumway M, Tolou-Shams M, McCaffrey N, Dauria EF. eHealth-Enhanced Peer Navigation for Substance Use Treatment and HIV Prevention Service Linkage for Young Adults Surveilled by the Criminal Legal System: Protocol for a Pilot Randomized Trial Study. JMIR Res Protoc. 2024 Mar 26;13:e54815. doi: 10.2196/54815.
PubMed 38530335
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults
- ClinicalTrials.gov ID
- NCT07599722
- Acronym / sponsor ID
- LYNX / STUDY22020053 (Aim 3)
- Conditions
- HIV Prevention, Substance Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
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 designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools.
The study will:
- Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services.
- Refine and test the updated program to make sure it works well and is easy to use.
- Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services.
The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareStandard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community. |
| LYNX Intervention | Experimental | Behavioral: LYNXProject LYNX is a new program designed to help young adults involved in the criminal legal system (ages 18-29) get connected to substance use treatment and HIV-prevention services. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-report recent criminal legal involvement (past year);
- Self-identify as HIV-negative
- Endorse behaviors in the past 6 months indicating consideration of PrEP per the Center for Disease Control and Prevention's (CDC) risk indices
- Meet the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tools' criteria for identifying the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder
- Are conversant in English.
Key exclusion criteria (3 listed)
- Being on Pre-exposure Prophylaxis (PrEP)
- Cognitive delays that would interfere with consent or participation
- Inability to provide contact information for >2 locator individuals
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 |
|---|---|---|
| LYNXLYNX is an mHealth enhanced, adapted navigator program designed to refer and link young adults (18 to 29 years) impacted by the criminal legal system to services related to substance use and HIV. | Behavioural | LYNX Intervention |
| Standard of CareStandard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community. | Behavioural | Standard of Care |
Primary outcome
Linkage to substance use services
Time frame: Time Frame: 4 month post-enrollment
Substance use service linkage will be attendance at a substance use service appointment via self-report via the question: " Did you attend your first appointment with your substance use treatment provider?" Yes or No. The investigators will report the number of participants that answered with each response option.
Linkage to Pre-exposure Prophylaxis Services
Time frame: Time Frame: 4 month post-enrollment
Pre-exposure Prophylaxis (PrEP) linkage will be self-reported engagement in PrEP related services in the last month via the question " Have you received any PrEP-related services in the past [month/3 months]?" Yes or No. The investigators will report the number of participants that answered with each response option.
12 secondary outcomes
Pre-exposure Prophylaxis Referral
Time frame: Time Frame: 4 month post-enrollment
Time to Pre-exposure Prophylaxis Linkage
Time frame: Time Frame: 4 month post-enrollment
Receipt of Pre-exposure Prophylaxis Prescription
Time frame: Time Frame: 4 month post-enrollment
Fill of Pre-exposure Prophylaxis Prescription
Time frame: Time Frame: 4 month post-enrollment
Pre-exposure Prophylaxis Initiation
Time frame: Time Frame: 4 month post-enrollment
Pre-exposure Prophylaxis Adherence
Time frame: Time Frame: 4-month post-enrollment
Pre-exposure Prophylaxis Persistence
Time frame: Time Frame: 4-month post-enrollment
Accepted Substance Use Service Referral
Time frame: Time Frame: 4 month post-enrollment
Time to Substance Use Linkage
Time frame: Time Frame: 4 month post-enrollment
Navigation Satisfaction Tool
Time frame: Time Frame: 4-month post-enrollment
Client Intervention Satisfaction
Time frame: Baseline, 1-month post enrollment, 3-months post-enrollment
Perceived Navigator Similarity
Time frame: Time Frame: 4-month post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 38530335Creasy SL, Sweet S, Myers JJ, Shumway M, Tolou-Shams M, McCaffrey N, Dauria EF. eHealth-Enhanced Peer Navigation for Substance Use Treatment and HIV Prevention Service Linkage for Young Adults Surveilled by the Criminal Legal System: Protocol for a Pilot Randomized Trial Study. JMIR Res Protoc. 2024 Mar 26;13:e54815. doi: 10.2196/54815.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Results will be published by the investigators in academic journals.
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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.
Emily Dauria, PhD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYNX in people with HIV Prevention and Substance Use, run by University of Pittsburgh at 1 site 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Dauria, PhD, MPH (412-383-0732, efd16@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to substance use services (time frame: Time Frame: 4 month post-enrollment). 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 NCT07599722, which also lists 1 linked publication.
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 20 Oct 2026.