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NCT Number: NCT07667101

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

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.

Recruiting

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Key information

Conditions

HEPATITIS C (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location status: Recruiting

Location contact

Judith I Tsui, MD MPH

CONTACT

[email protected]

2067441835

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. HCV Evaluation

    Time frame: 12 months

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

Secondary outcomes

  1. HCV Pre-Treatment Work-Up Completion ("Adoption")

    Time frame: 12 months

    This secondary outcome measures completion of work-up needed prior to initiation of treatment.

  2. DAA Initiation

    Time frame: 12 months

    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").

  3. DAA completion

    Time frame: 12 months

    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").

  4. Sustained Virologic Response

    Time frame: 12 months

    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").

  5. Injection Drug Use

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Gojic

CONTACT

[email protected]

Devin N Kennedy

CONTACT

[email protected]

206-744-1838

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: HepP3

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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