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Transforming the Cascade Of Hepatitis C Care

2021年1月14日 更新者:Norman Randall Kolb、University of Pittsburgh

Transforming the Cascade of Hepatitis C Care

Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a small minority of those in need of treatment receive it; 3) Members of minorities and older patients are even less likely to receive needed care; and 4) Until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings.

Community Health Centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. Therefore, these can be ideal places to deliver complex HCV care if they possess the needed expertise. However, most community-based primary care and community health centers lack access to Hepatitis C evaluation and treatment services, leading to a major public health problem.

Thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation rates at each of these sites is estimated as less than 10%. The investigators hypothesize that our project will increase the rate of participation in all the steps of the HCV care cascade and ultimately lead to more than doubled rates of treatment uptake

研究概览

地位

完全的

条件

详细说明

Primary Objective:

Determine uptake, effectiveness and safety of IFN-free, DAAs among "real world" patients, including those with multiple comorbidities, in the primary care setting.

Secondary Objective(s):

  1. Demonstrate the transformation of the cascade of Hepatitis C Care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to HCV care including HCV screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate.
  2. Advance understanding of hepatitis C related decision-making in the era of Interferon (IFN)-free Direct acting agents (DAAs) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis C treatment at primary care clinics

研究类型

观察性的

注册 (实际的)

325

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。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • UPMC Shadyside Family Health Center

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers

描述

Inclusion Criteria:

  • All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers

Exclusion Criteria:

  • Criteria for automatic specialty referral (exclusion from treatment at community health centers) Child Turcotte Pugh Class B or C Any history of decompensated liver disease or hepatocellular carcinoma Evidence of renal disease (GFR <50) or coexisting autoimmune condition HIV of hepatitis B co-infection

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

  • 观测模型:其他
  • 时间观点:预期

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
Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
大体时间:three years
measure percentage of patients moving through the cascade of care to cure of condition (SVR 12)
three years

次要结果测量

结果测量
措施说明
大体时间
Rates of Hepatitis C Virus (HCV) screening
大体时间:three years
Percentage of at risk patients in the practice who have a completed HCV antibody test
three years
Rate of Chronic Hepatitis C evaluation
大体时间:three years
Percentage of patients with a positive HCV antibody test who have a HCV polymerase chain reaction (PCR) viral load completed
three years
Rate of treatment consideration
大体时间:three years
Percentage of consented patients with a positive HCV viral load who have a clinical evaluation and assessment of psychosocial readiness for treatment documented in the medical record
three years
Rate of treatment uptake
大体时间:three years
Percentage of patients recommended for treatment who begin medical treatment
three years
Rate of treatment completion
大体时间:three years
Percentage of patients that began treatment who complete the recommended course of therapy
three years
Rate of patients lost to follow up
大体时间:three years
Percent of consented patients with a positive HCV viral load who are lost to follow up
three years
Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):
大体时间:three years
Endpoints related to HCV capacity building among family medicine physicians: Evaluate comfort and skill among family physicians to evaluate and treat HCV infection as measured on a qualitative survey of physicians
three years

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。

赞助

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)

2016年9月1日

初级完成 (实际的)

2019年9月30日

研究完成 (实际的)

2021年1月14日

研究注册日期

首次提交

2017年2月27日

首先提交符合 QC 标准的

2017年7月20日

首次发布 (实际的)

2017年7月21日

研究记录更新

最后更新发布 (实际的)

2021年1月19日

上次提交的符合 QC 标准的更新

2021年1月14日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • PRO16040427

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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