Clinical trial NCT05710120: Hepatitis C Screening Alerts
Official title: Hepatitis C Screening: HCV Risk Score Alerts in CHORUS™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Epividian
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
name: ZS
name: AIDS Healthcare Foundation
First posted: 2023-02-02
Enrollment: 125706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic Population: AIDS Healthcare Foundation Healthcare Centers across the United States and Puerto Rico are included in the study.

Patient Population: Adult patients without diagnosed HCV infection who are HCV screening eligible at AIDS Healthcare Foundation Healthcare Centers are included in the study.

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Screening to Diagnosis Ratio for Hepatitis C Infection
timeFrame: End of follow-up (Before study period: October 2022; After study period: October 2023)
Secondary outcomes:
measure: Screening Tests for Hepatitis C Infection
timeFrame: End of follow-up (Before study period: October 2022; After study period: October 2023)
measure: HCV RNA Viral Load Tests
timeFrame: End of follow-up (Before study period: October 2022; After study period: October 2023)
measure: HCV Screening History
timeFrame: Baseline (Before study period: January 2022; After study period: January 2023)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
Study officials:
affiliation: Mount Sinai Healthcare System
name: Douglas Dieterich, MD
role: PRINCIPAL_INVESTIGATOR
References: