Hepatitis C Screening Alerts

Epividian

Status: Completed

Conditions: Hepatitis C

Treatments: Other: Hepatitis C Screening Alerts in CHORUS™; Other: Standard of Care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05710120

COL2023-002

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 125,706 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• <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

Trial design

125,706 participants in 2 patient groups

Before Period (January 2022 to October 2022)

Description:

All AIDS Healthcare Foundation Healthcare Centers will be contributing to the before phase of this study. In the before phase, alerts identifying patients who are eligible to be screened for hepatitis C infection will NOT be disseminated to healthcare providers and clinic staff. Routine clinical care will be administered without knowledge of the intervention.

Treatment:

Other: Standard of Care

After Period (January 2023 to October 2023)

Description:

All AIDS Healthcare Foundation Healthcare Centers will be contributing to the after phase of this study. In the after phase, alerts identifying patients who are are eligible to be screened for hepatitis C infection will be disseminated to healthcare providers and clinic staff.

Treatment:

Other: Hepatitis C Screening Alerts in CHORUS™