Hepatitis C Screening Alerts

Hepatitis C Screening: HCV Risk Score Alerts in CHORUS™

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Other: Standard of Care; Other: Hepatitis C Screening Alerts in CHORUS™

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).

• Study Type: Observational
• Enrollment (Actual): 125706

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90028
      • Aids Healthcare Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before Period (January 2022 to October 2022); 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.	Other: Standard of Care; CHORUS™ is a service provided to participating clinics and has been used by AIDS Healthcare Foundation for normal healthcare operations for quality improvement and retention in care in recent years. NO alerts identifying patients who are eligible to be screening for hepatitis C infection will be disseminated.
After Period (January 2023 to October 2023); 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.	Other: Hepatitis C Screening Alerts in CHORUS™; ZS Associates developed a machine learning-based model that provides a numeric % chance of returning a positive hepatitis C test for a patient without diagnosed hepatitis C infection. The data used to develop the model included a US-based large scale data source including electronic medical records, medical claims, and pharmacy claims as well as social determinants of health identified from open-source data. Clinical Health Outcomes Reporting & Utilization Service (CHORUS™) is a web-based reporting solution that transforms electronic health record data into meaningful information for healthcare providers. CHORUS™ generates a weekly email report that alerts clinics to patients who have a scheduled appt in the coming week and may require attention. In the after period of this study, the alert will identify patients who are eligible to be screened for hepatitis C infection and provide the % chance of returning a positive hepatitis C infection test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening to Diagnosis Ratio for Hepatitis C Infection	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).	End of follow-up (Before study period: October 2022; After study period: October 2023)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Tests for Hepatitis C Infection	Proportion of HCV screening-eligible patients who receive HCV antibody test alone, HCV RNA test alone, and reactive HCV antibody test followed by an HCV RNA or genotype test.	End of follow-up (Before study period: October 2022; After study period: October 2023)
HCV RNA Viral Load Tests	Among individuals who screen positive for HCV infection (i.e., reactive HCV antibody test) over follow-up, the distribution of HCV RNA test results (i.e., detectable, not detectable)	End of follow-up (Before study period: October 2022; After study period: October 2023)
HCV Screening History	The HCV screening history for HCV screening-eligible individuals who were previously HCV negative but are at high-risk for HCV infection (i.e., HIV-infected men who have sex with men and people who inject drugs) will be described.	Baseline (Before study period: January 2022; After study period: January 2023)

Collaborators and Investigators

• Sponsor: Epividian
• Collaborators: Gilead Sciences; AIDS Healthcare Foundation; ZS
• Investigators: Principal Investigator: Douglas Dieterich, MD, Mount Sinai Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: COL2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No