Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing (HepP3)

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.

Study Overview

• Status: Recruiting
• Conditions: HEPATITIS C (HCV)
• Intervention / Treatment: Other: PPP-CCM

• Study Type: Interventional
• Enrollment (Estimated): 444
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin N Kennedy; Phone Number: 206-744-1838; Email: kennedev@uw.edu
• Study Contact Backup: Name: Alex Gojic; Email: agojic@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Harborview Medical Center
      • Contact: Judith I Tsui, MD MPH; Phone Number: 2067441835; Email: tsuij@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment-as-usual (TAU); TAU will be usual care provided by the permanent supportive housing buildings.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV Evaluation	The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no").	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV Pre-Treatment Work-Up Completion ("Adoption")	This secondary outcome measures completion of work-up needed prior to initiation of treatment.	12 months
DAA Initiation	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").	12 months
DAA completion	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").	12 months
Sustained Virologic Response	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").	12 months
Injection Drug Use	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.	12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Judith Tsui, MD, MPH, University of Washington; Principal Investigator: Sara Glick, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: R01DA062638 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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