Hepatitis C Diagnosis to Treatment Management

NCT05725109 | Completed

• 1 other identifier: COL2023-001
• Study Type: observational
• Target: 1,063
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Prescriptions for HCV treatment

  Proportion of patients who are prescribed HCV treatment over follow-up, out of patients with a completed visit over follow-up.

  End of follow-up, up to 9 months

Secondary Outcomes (1)

• HCV RNA viral load tests

  End of follow-up, up to 9 months

Study Arms (2)

Before Period (1/16/2022 to 10/17/2022)

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

After Period (1/16/2023 to 10/17/2023)

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™

Interventions

Hepatitis C Treatment Alerts in CHORUS™ OTHER

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.

After Period (1/16/2023 to 10/17/2023)

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 with active hepatitis C infection will be disseminated.

Before Period (1/16/2022 to 10/17/2022)

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 with active, untreated HCV infection 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
• Active, untreated HCV infection

You may not qualify if:

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

Sponsors & Collaborators

• Epividian: lead
• Gilead Sciences: 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

• Michael Wohlfeiler, MD

  AIDS Healthcare Foundation

  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 13, 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)