Hepatitis C Screening: HCV Risk Score Alerts in CHORUS™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Epividian
- 入组人数
- 125,706
- 试验地点
- 1
- 主要终点
- Screening to Diagnosis Ratio for Hepatitis C Infection
研究概览
简要总结
The objective of this study is to evaluate whether alerts that identify patients without hepatitis C infection to healthcare providers and clinic staff can increase the uptake of screening for hepatitis C. A period of time without alerts will be compared to a period of time with alerts.
详细描述
An estimated 2.4 million people in the United States were living with hepatitis C virus (HCV) infection during the period of 2013-2016. There were 4,798 new cases of acute HCV infection reported to the Centers for Disease Control (CDC) in 2020, but under ascertainment and underreporting of cases suggests that this number is less than 10% of all new HCV infections; as such, there were an estimated 66,700 new cases in 2020.
One-time screening is recommended by both the CDC and the United States Preventive Services Task Force for asymptomatic adults (aged ≥18 years and 18-79 years, respectively). The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America additionally recommends annual testing for people who inject drugs and for HIV-infected men who have sex with men. Unfortunately, HCV screening rates remain low. The objective of this before and after study is to evaluate if an HCV screening algorithm, disseminated as risk score alerts in the CHORUS™ Disease Management and Clinical Considerations Report to healthcare providers and clinic staff, increases the uptake of HCV screening among patients who are HCV screening-eligible (i.e., not known to have current or prior HCV infection).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •18+ years of age
- •In care at an AIDS Healthcare Foundation Healthcare Center
- •HCV screening eligible
- •Individuals who are HCV screening eligible include:
- •HCV unknown: Never received an HCV antibody, RNA, or genotype test
- •Previously HCV negative, high-risk for HCV infection: HIV-infected men who have sex with men or people who inject drugs with ≥ 1 prior negative HCV antibody or RNA test(s) who have not been screened in the prior 12 months
排除标准
- •<18 years of age
- •Diagnosed HCV infection (i.e., reactive HCV antibody, detectable HCV RNA test, or HCV genotype test)
- •Individuals with diagnosed HCV infection include:
- •Acute HCV infection, untreated or in treatment
- •Chronic HCV infection, untreated or in treatment
- •Spontaneous clearance of prior HCV infection
- •Sustained virologic response after direct acting antiviral therapy for prior HCV infection
- •Treatment failure after direct acting antiviral therapy for prior HCV infection
结局指标
主要结局
Screening to Diagnosis Ratio for Hepatitis C Infection
时间窗: End of follow-up (Before study period: October 2022; After study period: October 2023)
Number of HCV screening-eligible individuals who complete a visit and who are screened by either an HCV antibody or HCV RNA test divided by the number of individuals whose HCV RNA test returns a detectable result (i.e., people with active HCV infection).
次要结局
- HCV Screening History(Baseline (Before study period: January 2022; After study period: January 2023))
- HCV RNA Viral Load Tests(End of follow-up (Before study period: October 2022; After study period: October 2023))
- Screening Tests for Hepatitis C Infection(End of follow-up (Before study period: October 2022; After study period: October 2023))