HIV Prevention, Substance Use
Conditions
Brief 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. 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.
Interventions
BEHAVIORALLYNX
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.
BEHAVIORALStandard 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.
Sponsors
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to substance use services | 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. We will report the number of participants that answered with each response option. |
| Linkage to PrEP Services | Time Frame: 4 month post-enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Referral | Time Frame: 4 month post-enrollment | 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 to PrEP Linkage | Time Frame: 4 month post-enrollment | 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. |
| Receipt of PrEP Prescription | Time Frame: 4 month post-enrollment | 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. |
| Fill of PrEP Prescription | Time Frame: 4 month post-enrollment | 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. |
| PrEP Initiation | Time Frame: 4 month post-enrollment | 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. |
| PrEP Adherence | Time Frame: 4-month post-enrollment | 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. |
| PrEP Persistence | Time Frame: 4-month post-enrollment | 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. |
| Accepted Substance Use Service Referral | Time Frame: 4 month post-enrollment | 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 to Substance Use Linkage | Time Frame: 4 month post-enrollment | 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. |
| Navigation Satisfaction Tool | Time Frame: 4-month post-enrollment | 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. |
| Client Intervention Satisfaction | Baseline, 1-month post enrollment, 3-months post-enrollment | 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. |
| Perceived Navigator Similarity | Time Frame: 4-month post-enrollment | 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. |
Countries
United States
Contacts
CONTACTEmily Dauria, PhD, MPH
CONTACTSheridan Sweet, MPH
PRINCIPAL_INVESTIGATOREmily Dauria, PhD, MPH
University of Pittsburgh
Outcome results
None listed