mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System (LYNX)

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention; Substance Use
• Intervention / Treatment: Behavioral: Standard of Care; Behavioral: LYNX

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Dauria, PhD, MPH; Phone Number: 412-383-0732; Email: efd16@pitt.edu
• Study Contact Backup: Name: Sheridan Sweet, MPH; Phone Number: (412) 613-8817; Email: SHS406@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • University of Pittsburgh, School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Being on PrEP
• Cognitive delays that would interfere with consent or participation
• Inability to provide contact information for >2 locator individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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.	Behavioral: Standard of Care; 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.
Experimental: LYNX Intervention; 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.	Behavioral: LYNX; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment
Linkage to PrEP Services	Pre-exposure Prophylaxis 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. We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Referral	PrEP referral be reported via self-report via the question: "Has your navigator offered to connect you to PrEP services?" Yes or No. We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment
Time to PrEP Linkage	Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to PrEP services and the date they recorded the participant first attended a PrEP related appointment. We will report the average number of days between the date of referral and first appointment attendance.	Time Frame: 4 month post-enrollment
Receipt of PrEP Prescription	Receipt of a PrEP prescription will be identified via self-report via the question "Have you received a prescription for PrEP?". Yes or No. We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment
Fill of PrEP Prescription	Fill of a PrEP prescription will be identified via self-report via the question: "Have you filled your PrEP prescription?" Yes or No. We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment
PrEP Initiation	PrEP initiation will be identified via self-report via the question: "Have you started to take PrEP?" Yes or No . We will report the number of participants that answered with each response option.	Time Frame: 4 month post-enrollment
PrEP Adherence	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. We will report the number of participants that answered with each response option.	Time Frame: 4-month post-enrollment
PrEP Persistence	PrEP persistence will be identified through self-report via the question: "Have you stopped taking PrEP?: Yes or No. We will report the number of participants that answered with each response option.	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. We will report the number of participants that answered with each response option.	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. We will report the average number of days between the date of referral and first appointment attendance.	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. We will report the mean and the standard deviation for the NAVSAT score.	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.	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). We will calculate a total score by summing all items, with higher scores indicating greater perceived similarity.	Time Frame: 4-month post-enrollment

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Emily Dauria, PhD, MPH, University of Pittsburgh

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: STUDY22020053 (Aim 3); 5R34DA057891-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Results will be published by the investigators in academic journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No