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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA062638 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-as-usual (TAU) | No Intervention | TAU will be usual care provided by the permanent supportive housing buildings. | |
| PPP-CCM | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPP-CCM | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Evaluation | The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no"). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Pre-Treatment Work-Up Completion ("Adoption") | This secondary outcome measures completion of work-up needed prior to initiation of treatment. | 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"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Devin N Kennedy | Contact | 206-744-1838 | kennedev@uw.edu | |
| Alex Gojic | Contact | agojic@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Judith Tsui, MD, MPH | University of Washington | Principal Investigator |
| Sara Glick, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| 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"). | 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"). | 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. | 12 months |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |