Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing (HepP3)
18. juni 2026 opdateret af: Judith I. Tsui, University of Washington
A Hybrid Implementation-Effectiveness Study of the Pharmacist, Physician, and Patient Navigator Collaborative Care Model (PPP-CCM) to Cure Hepatitis C Among Persons Who Use Drugs With Housing Insecurity
The objective of this study is to extend our prior research by conducting a pragmatic implementation trial using a parallel-group, cluster randomized design to evaluate the PPP-CCM's ability to improve access to DAAs for HCV within a network of permanent supportive housing (PSH) buildings in Seattle and King County.
The study will implement PPP-CCM to 16 housing buildings, randomizing half to receive PPP-CCM (intervention) versus usual care (UC) for 12-months, after which all buildings will have access to PPP-CCM.
All buildings will have access to point-of-care HCV screening for the first 6 months of the study.
Study outcome data will be collected through a longitudinal cohort-study of persons who screened positive for HCV which will conduct surveys and review of medical records at baseline, 12- and 24-months.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
444
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Devin N Kennedy
- Telefonnummer: 206-744-1838
- E-mail: kennedev@uw.edu
Undersøgelse Kontakt Backup
- Navn: Alex Gojic
- E-mail: agojic@uw.edu
Studiesteder
-
-
Washington
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Harborview Medical Center
-
Kontakt:
- Judith I Tsui, MD MPH
- Telefonnummer: 2067441835
- E-mail: tsuij@uw.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adult ≥18 years of age
- Currently a resident at one of DESC's PSH buildings at the time of study enrollment
- Positive HCV test documented (screening antibody test or viral load test)
- Provides release of information (ROI) to access community pharmacy electronic medical records (EHR) and/or other HCV treatment providers for information on HCV care during the study period between baseline visit and 24-month visit
Exclusion Criteria:
- Taking medications to treat HCV at the start of the study
- Cognitive impairment (acute or chronic) resulting in inability to provide informed consent
- Currently or impending incarceration
- People who plan to leave the Seattle area within 24 months
- Not English speaking
- Behavioral risk posing safety concerns per discretion of research staff
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Treatment-as-usual (TAU)
TAU will be usual care provided by the permanent supportive housing buildings.
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|
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Eksperimentel: PPP-CCM
The intervention is a "Pharmacist, Physician, Patient Navigator Collaborative Care Model" (PPP-CCM) approach for expanding access to direct-acting antivirals (DAAs) for HCV.
This task-shifting, collaborative care model leverages pharmacists to deliver medications-namely DAAs for HCV, as well as pre-exposure prophylaxis (PrEP) for HIV and naloxone for overdose prevention-to PWUD through "Collaborative Practice Agreements" (CPAs) with physicians in conjunction with support from patient navigators.
|
The intervention is a "Pharmacist, Physician, Patient Navigator Collaborative Care Model" (PPP-CCM) approach for expanding access to direct-acting antivirals (DAAs) for HCV.
This task-shifting, collaborative care model leverages pharmacists to deliver medications-namely DAAs for HCV, as well as pre-exposure prophylaxis (PrEP) for HIV and naloxone for overdose prevention-to PWUD through "Collaborative Practice Agreements" (CPAs) with physicians in conjunction with support from patient navigators.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HCV Evaluation
Tidsramme: 12 months
|
The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no").
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HCV Pre-Treatment Work-Up Completion ("Adoption")
Tidsramme: 12 months
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This secondary outcome measures completion of work-up needed prior to initiation of treatment.
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12 months
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DAA Initiation
Tidsramme: 12 months
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This secondary outcome is defined as the act of being prescribed and taking at least one dose of a DAA medication for HCV ("yes" versus "no").
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12 months
|
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DAA completion
Tidsramme: 12 months
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This secondary outcome is defined as being prescribed and having received a full course of DAA treatment with no interruption >14 days ("yes" versus "no").
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12 months
|
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Sustained Virologic Response
Tidsramme: 12 months
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This secondary outcome is defined as having documentation in the EHR of an undetectable HCV viral load ≥ 4 weeks after the completion of DAA treatment ("yes" versus "no").
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12 months
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Injection Drug Use
Tidsramme: 12 months
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This secondary outcome is defined as self-reported number of days of injecting drugs (a major risk factor for HIV and HCV infection/reinfection) in the past 30 days.
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Judith Tsui, MD, MPH, University of Washington
- Ledende efterforsker: Sara Glick, PhD, University of Washington
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. juni 2029
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01DA062638 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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