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

NCT07667101 | Recruiting DMC

• 1 other identifier: R01DA062638
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HEPATITIS C (HCV)

Outcome Measures

Primary Outcomes (1)

• HCV Evaluation

  The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no").

  12 months

Secondary Outcomes (5)

• HCV Pre-Treatment Work-Up Completion ("Adoption")

  12 months

• DAA Initiation

  12 months

• DAA completion

  12 months

• Sustained Virologic Response

  12 months

• Injection Drug Use

  12 months

Study Arms (2)

Treatment-as-usual (TAU)

NO INTERVENTION

TAU will be usual care provided by the permanent supportive housing buildings.

PPP-CCM

EXPERIMENTAL

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

Interventions

PPP-CCM OTHER

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.

PPP-CCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Judith Tsui, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Sara Glick, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devin N Kennedy

CONTACT

206-744-1838; kennedev@uw.edu

Alex Gojic

CONTACT

agojic@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)