Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing (HepP3)
2026年6月18日 更新者：Judith I. Tsui、University of Washington
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
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.
研究概览
研究类型
介入性
注册 (估计的)
444
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Devin N Kennedy
- 电话号码：206-744-1838
- 邮箱：kennedev@uw.edu
研究联系人备份
- 姓名：Alex Gojic
- 邮箱：agojic@uw.edu
学习地点
-
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Washington
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Seattle、Washington、美国、98104
- 招聘中
- Harborview Medical Center
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接触：
- Judith I Tsui, MD MPH
- 电话号码：2067441835
- 邮箱：tsuij@uw.edu
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Treatment-as-usual (TAU)
TAU will be usual care provided by the permanent supportive housing buildings.
|
|
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实验性的：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.
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HCV Evaluation
大体时间：12 months
|
The primary outcome of interest is whether a participant received an evaluation for hepatitis C ("yes" versus "no").
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HCV Pre-Treatment Work-Up Completion ("Adoption")
大体时间：12 months
|
This secondary outcome measures completion of work-up needed prior to initiation of treatment.
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12 months
|
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DAA Initiation
大体时间：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").
|
12 months
|
|
DAA completion
大体时间：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").
|
12 months
|
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Sustained Virologic Response
大体时间：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").
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12 months
|
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Injection Drug Use
大体时间：12 months
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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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Judith Tsui, MD, MPH、University of Washington
- 首席研究员：Sara Glick, PhD、University of Washington
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2029年6月1日
研究注册日期
首次提交
2026年6月18日
首先提交符合 QC 标准的
2026年6月18日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年6月24日
上次提交的符合 QC 标准的更新
2026年6月18日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.