Hepatitis C Diagnosis to Treatment Management

Completed

• Conditions: Hepatitis C
• Interventions: Other: Standard of Care; Other: Hepatitis C Treatment Alerts in CHORUS™

• Registration Number: NCT05725109
• Lead Sponsor: Epividian

Brief Summary

The objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of hepatitis C treatment. A period of time without alerts will be compared to a period of time with alerts.

Detailed Description

The hepatitis C virus (HCV) is one of the most common bloodborne pathogens in the United States. A large proportion of people with HCV infection progress to chronic HCV infection despite the availability of effective treatment; chronic infection can result in cirrhosis, end-stage liver disease, liver cancer, and liver-related death. HCV infection can be cured most of the time with treatment. The objective of this before and after study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of HCV treatment. A period of time without alerts will be compared to a period of time with alerts. Healthcare providers and clinic staff will not receive alerts during the before period of the study. Healthcare providers and clinic staff will receive alerts during the after period of the study.

Study Timeline

• Study First Submitted: 2023-01-10
• Study Start: 2023-01-16
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1063

Inclusion Criteria

• 18+ years of age
• In care at an AIDS Healthcare Foundation Healthcare Center
• Active, untreated HCV infection

Exclusion Criteria

• <18 years of age
• Patients with active HCV infection who have a current prescription for HCV treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before Period (1/16/2022 to 10/17/2022)	Standard of Care	All AIDS Healthcare Foundation Healthcare Centers will be contributing to the before phase of this study. In the before phase, alerts identifying patients with active hepatitis C infection will NOT be disseminated to healthcare providers and clinic staff. Routine clinical care will be administered without knowledge of the intervention.
After Period (1/16/2023 to 10/17/2023)	Hepatitis C Treatment Alerts in CHORUS™	All AIDS Healthcare Foundation Healthcare Centers will be contributing to the after phase of this study. In the after phase, alerts identifying patients with active hepatitis C infection will be disseminated to healthcare providers and clinic staff.

Primary Outcome Measures

Name	Time	Method
Prescriptions for HCV treatment	End of follow-up, up to 9 months	Proportion of patients who are prescribed HCV treatment over follow-up, out of patients with a completed visit over follow-up.

Secondary Outcome Measures

Name	Time	Method
HCV RNA viral load tests	End of follow-up, up to 9 months	Frequency of HCV RNA viral load tests that occur between the first visit over follow-up and the first censoring event

Trial Locations

Locations (1)

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States