HEPATITIS C (HCV)
Conditions
Brief 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.
Interventions
OTHERPPP-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.
Sponsors
University of Washington
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV Evaluation | 12 months | The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV Pre-Treatment Work-Up Completion ("Adoption") | 12 months | This secondary outcome measures completion of work-up needed prior to initiation of treatment. |
| DAA Initiation | 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"). |
| DAA completion | 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"). |
| Sustained Virologic Response | 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"). |
| Injection Drug Use | 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. |
Countries
United States
Contacts
CONTACTDevin N Kennedy
CONTACTAlex Gojic
PRINCIPAL_INVESTIGATORJudith Tsui, MD, MPH
University of Washington
PRINCIPAL_INVESTIGATORSara Glick, PhD
University of Washington
Outcome results
None listed