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

University of Washington444 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

444

Conditions

HEPATITIS C (HCV)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HCV Evaluation

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

Time frame: 12 months

Secondary Outcomes

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

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

Time frame: 12 months

DAA Initiation

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").

Time frame: 12 months

DAA completion

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").

Time frame: 12 months

Sustained Virologic Response

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").

Time frame: 12 months

Injection Drug Use

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.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts