Gemeinsame Entscheidungsfindung zur Behandlung oder Prävention (STOP) von HIV in Justizpopulationen (R33)
STOP (Gemeinsame Entscheidungsfindung zur Behandlung oder Prävention) HIV in Justizpopulationen
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Alysse Schultheis, MA
- Telefonnummer: 203-231-2454
- E-Mail: alysse.schultheis@yale.edu
Studieren Sie die Kontaktsicherung
- Name: Sandra Springer, MD
- Telefonnummer: 203-231-2454
- E-Mail: Sandra.springer@yale.edu
Studienorte
-
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Rekrutierung
- Yale School of Medicine
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Hauptermittler:
- Sandy Springer, MD
-
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40506
- Rekrutierung
- College of Medicine at the University of Kentucky
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Hauptermittler:
- Michele Staton, PhD, MSW
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390
- Rekrutierung
- University of Texas Southwestern Medical Center (UTSW)
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Hauptermittler:
- Ank Nijhawan, MD, MPH
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Fort Worth, Texas, Vereinigte Staaten, 76109
- Rekrutierung
- Texas Christian University's (TCU) School of Medicine
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Hauptermittler:
- Kevin Knight,, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- Having a history of opioid and/or stimulant use in the last 12 months within the community.
Exclusion Criteria:
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Standard Patient Navigation (PN)
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling. |
Standard of care |
|
Experimental: PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment. |
Standard of care Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of participants who initiate or re-initiate PrEP
Zeitfenster: 6 months
|
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report |
6 months
|
|
Percentage of participants who initiate or re-initiate ART
Zeitfenster: 6 months
|
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report |
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of participants that adhere to PrEP
Zeitfenster: 6 and 12 months
|
Percentage of participants that adhere to PrEP |
6 and 12 months
|
|
Percentage of participants retaining on PrEP
Zeitfenster: 6 and 12 months
|
Percentage of participants retaining on PrEP |
6 and 12 months
|
|
HIV incidence
Zeitfenster: 6 and 12 months
|
HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time |
6 and 12 months
|
|
Percentage of participants that adhere to ART
Zeitfenster: 6 and 12 months
|
Percentage of participants that adhere to ART |
6 and 12 months
|
|
ART retention
Zeitfenster: 6 and 12 months
|
For persons living with HIV (PLH), ART retention [binary] |
6 and 12 months
|
|
Substance use treatment
Zeitfenster: 6 and 12 months
|
Percentage of participants engaged in substance use disorder (SUD) treatment |
6 and 12 months
|
|
HIV viral suppression
Zeitfenster: 6 months
|
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months |
6 months
|
|
Retention in HIV PrEP/ART
Zeitfenster: 6 months
|
Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months |
6 months
|
|
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
Zeitfenster: 6 and 12 months
|
Number of Participants Who Had Any Needle Sharing Activity |
6 and 12 months
|
|
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
Zeitfenster: 6 and 12 months
|
Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
6 and 12 months
|
|
Days of using opioids
Zeitfenster: 6 and 12 months
|
Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use |
6 and 12 months
|
|
Number of participants with with overdose events
Zeitfenster: 6 and 12 months
|
Number of participants with non-fatal and fatal overdose events |
6 and 12 months
|
|
Percentage of participants with retention in SUD treatment
Zeitfenster: 6 and 12 months
|
Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) |
6 and 12 months
|
|
Quality of Life assessed using PROMIS-PROPr
Zeitfenster: 6 and 12 months
|
PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. |
6 and 12 months
|
|
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 6 and 12 months
|
Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. |
6 and 12 months
|
|
Recidivism: Reasons
Zeitfenster: 6 and 12 months
|
Number of participants per reason for arrest/ incarceration/return-to-custody |
6 and 12 months
|
|
Recidivism: Mean days in custody/incarcerated
Zeitfenster: 6 and 12 months
|
Mean days in custody/incarcerated |
6 and 12 months
|
|
Recidivism: Mean days to return
Zeitfenster: 6 and 12 months
|
Mean days to return to custody/incarcerated |
6 and 12 months
|
|
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
Zeitfenster: 6 and 12 months
|
Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma |
6 and 12 months
|
|
Percentage of participants diagnosed with SUD
Zeitfenster: Baseline and 12 months
|
Percentage of participants diagnosed with SUD using DSM-5 |
Baseline and 12 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Sandra Springer, MD, Yale University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Substanzbezogene Störungen
- Verwaltung des Gesundheitswesens
- Lieferung der Gesundheitsversorgung
- Gesundheitsökonomie und Organisationen
- Patientenversorgung Management
- Soziale Kontrolle, formal
- Finanzierung, organisiert
- Wirtschaft
- Krankenversicherung
- Versicherung
- Verwaltete Betreuungsprogramme
- Gesetzgebung als Thema
- Patientengesetze zur Wahlfreiheit
Andere Studien-ID-Nummern
- 2000037052_a
- 4R33DA060625-02 (US NIH Stipendium/Vertrag)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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