- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07599722
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Emily Dauria, PhD, MPH
- Numer telefonu: 412-383-0732
- E-mail: efd16@pitt.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Sheridan Sweet, MPH
- Numer telefonu: (412) 613-8817
- E-mail: SHS406@pitt.edu
Lokalizacje studiów
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15206
- University of Pittsburgh, School of Public Health
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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.
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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.
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Linkage to substance use services
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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Linkage to PrEP Services
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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PrEP Referral
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
|
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Time to PrEP Linkage
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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Receipt of PrEP Prescription
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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Fill of PrEP Prescription
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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PrEP Initiation
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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PrEP Adherence
Ramy czasowe: Time Frame: 4-month post-enrollment
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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.
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Time Frame: 4-month post-enrollment
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PrEP Persistence
Ramy czasowe: Time Frame: 4-month post-enrollment
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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.
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Time Frame: 4-month post-enrollment
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Accepted Substance Use Service Referral
Ramy czasowe: Time Frame: 4 month post-enrollment
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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
|
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Time to Substance Use Linkage
Ramy czasowe: Time Frame: 4 month post-enrollment
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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.
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Time Frame: 4 month post-enrollment
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Navigation Satisfaction Tool
Ramy czasowe: Time Frame: 4-month post-enrollment
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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.
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Time Frame: 4-month post-enrollment
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Client Intervention Satisfaction
Ramy czasowe: Baseline, 1-month post enrollment, 3-months post-enrollment
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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.
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Baseline, 1-month post enrollment, 3-months post-enrollment
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Perceived Navigator Similarity
Ramy czasowe: Time Frame: 4-month post-enrollment
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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.
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Time Frame: 4-month post-enrollment
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Emily Dauria, PhD, MPH, University of Pittsburgh
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY22020053 (Aim 3)
- 5R34DA057891-03 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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