Hepatitis C Diagnosis to Treatment Management

Sponsor
Epividian (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05725109
Collaborator
Gilead Sciences (Industry), AIDS Healthcare Foundation (Other)
3,500
1
9
390.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hepatitis C Treatment Alerts in CHORUS™
  • Other: Standard of Care

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 Design

Study Type:
Observational
Anticipated Enrollment :
3500 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Hepatitis C Disease Management: Diagnosis to Treatment Alerts in CHORUS™
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Oct 9, 2023
Anticipated Study Completion Date :
Oct 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Before Period (1/9/2022 to 10/9/2022)

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.

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 with active hepatitis C infection will be disseminated.

After Period (1/9/2023 to 10/9/2023)

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.

Other: Hepatitis C Treatment Alerts in CHORUS™
Clinical Health Outcomes Reporting & Utilization Service (CHORUS™) is a web-based healthcare analytics and 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 with certain conditions who have a scheduled appointment in the coming week and may require close attention. 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. In the after period of this study, the alert will identify patients with active hepatitis C infection.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AIDS Healthcare Foundation Los Angeles California United States 90028

Sponsors and Collaborators

  • Epividian
  • Gilead Sciences
  • AIDS Healthcare Foundation

Investigators

  • Principal Investigator: Michael Wohlfeiler, MD, AIDS Healthcare Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Epividian
ClinicalTrials.gov Identifier:
NCT05725109
Other Study ID Numbers:
  • COL2023-001
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023