Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PPP-CCM.
- Who it may be relevant to
- Registry conditions: HEPATITIS C (HCV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
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.
Interventions
- 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.
Primary outcome measures
- HCV Evaluation [Time frame: 12 months]
Secondary outcome measures (5)
- HCV Pre-Treatment Work-Up Completion ("Adoption") [Time frame: 12 months]
- DAA Initiation [Time frame: 12 months]
- DAA completion [Time frame: 12 months]
- Sustained Virologic Response [Time frame: 12 months]
- Injection Drug Use [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Harborview Medical Center — Seattle
Identifiers
NCT: NCT07667101 · R01DA062638 · R01DA062638