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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
Harborview Medical Center
RECRUITING
Seattle
Contact Information
Primary
Devin N Kennedy
kennedev@uw.edu
206-744-1838
Backup
Alex Gojic
agojic@uw.edu
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-06
Participants
Target number of participants: 444
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Washington

This content was sourced from clinicaltrials.gov