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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 444
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Judith I. Tsui
Study Principal Investigator
University of Washington
