STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,386
- 试验地点
- 2
- 主要终点
- Hepatitis C Screening
研究概览
简要总结
Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation.
Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 53 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born between 1945 and 1965
- •≥ 1 outpatient visit during 12 months prior to randomization at Parkland
- •no prior HCV screening (prior HCV antibody, viral load, or genotype).
- •any active medical coverage
- •speaks Spanish or English
排除标准
- •a life expectancy less than one year including end stage CHF, end stage COPD, metastatic cancer, and those who received a palliative care or hospice referral in the past year
- •history of HCC.
- •non-English or Spanish speakers
- •no address or phone number on file
结局指标
主要结局
Hepatitis C Screening
时间窗: 3 months
Proportion with HCV Ab within 3 months of randomization
次要结局
- Hepatitis C Screening(12 months)
- Hepatitis C Confirmation(3 months)
- Hepatitis C Linkage to care(6 months)
- Cost: Cost-per patient screened(3 months)
- Cost: Cost per-HCV diagnosis(12 months)
研究者
Amit Singal
Principal Investigator
University of Texas Southwestern Medical Center