跳至主要内容
临床试验/NCT03876470
NCT03876470Unknown不适用

Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs

University of Virginia0 个研究点目标入组 300 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
Cohort-level Hepatitis C Treatment Progress

研究概览

简要总结

The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.

详细描述

The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Detectable HCV viral load
  • Attended a clinic appointment at one of our participating sites

排除标准

  • Cognitive disability such that informed consent cannot be obtained
  • Prisoners
  • Unable to understand English

结局指标

主要结局

Cohort-level Hepatitis C Treatment Progress

时间窗: 12 months

Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation

次要结局

  • Patient Reported Quality-of-Life(12 months)
  • Depression(12 months)
  • Semi-Structured Qualitative Interview about Impact of HCV Treatment(12 months)
  • Health-Related Quality-of-Life(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Dillingham, MD/MPH

Director of the Center for Global Health

University of Virginia

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