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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Harborview Medical Center
Seattle, Washington 98104
Contact:
Judith I Tsui, MD MPH
2067441835
tsuij@uw.edu

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

Devin N Kennedy
206-744-1838
kennedev@uw.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.