Hepatitis C Screening Alerts

NCT05710120 | Completed

• 1 other identifier: COL2023-002
• Study Type: observational
• Target: 125,706
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Screening Tests for Hepatitis C Infection

  End of follow-up (Before study period: October 2022; After study period: October 2023)

• HCV RNA Viral Load Tests

  End of follow-up (Before study period: October 2022; After study period: October 2023)

• HCV Screening History

  Baseline (Before study period: January 2022; After study period: January 2023)

Study Arms (2)

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

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™

Interventions

Hepatitis C Screening Alerts in CHORUS™ OTHER

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.

After Period (January 2023 to October 2023)

Standard of Care OTHER

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.

Before Period (January 2022 to October 2022)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• + 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Epividian: lead
• Gilead Sciences: collaborator
• ZS: collaborator
• AIDS Healthcare Foundation: collaborator

Study Sites (1)

AIDS Healthcare Foundation

Los Angeles, California, 90028, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Douglas Dieterich, MD

  Mount Sinai Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 2, 2023
• Study Start: January 16, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)