Transforming the Cascade of Hepatitis C Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
研究概览
简要总结
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
详细描述
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):
- 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.
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers
排除标准
- •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
结局指标
主要结局
Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
时间窗: three years
measure percentage of patients moving through the cascade of care to cure of condition (SVR 12)
次要结局
- Rate of patients lost to follow up(three years)
- Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):(three years)
- Rate of treatment consideration(three years)
- Rates of Hepatitis C Virus (HCV) screening(three years)
- Rate of treatment uptake(three years)
- Rate of treatment completion(three years)
- Rate of Chronic Hepatitis C evaluation(three years)
研究者
Norman Randall Kolb
Principle Investigator; Associate Program Director UPMC Shadyside Family Medicine Residency
University of Pittsburgh