Recruiting

PPP-CCM

Sponsor:

University of Washington

Code:

NCT07667101

Conditions

HEPATITIS C (HCV)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PPP-CCM

Study Details

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)

Study ID

NCT07667101

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

444 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • HCV Evaluation [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Devin N Kennedy

206-744-1838kennedev@uw.edu

Alex Gojic

agojic@uw.edu

Locations

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Judith I Tsui, MD MPH

2067441835tsuij@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-06-24.