CClinicalTrials.gg
CompletedNCT05725109Updated Feb 16, 2024

Hepatitis C Diagnosis to Treatment Management

An observational study in Hepatitis C, sponsored by Epividian. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Epividian · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,063
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 1,063 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Epividian is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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 with active, untreated HCV infection at AIDS Healthcare Foundation Healthcare Centers are included in the study.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
1,063 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherHepatitis 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.

  • OtherStandard 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.

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What researchers measure

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.

    Time frame: End of follow-up, up to 9 months

Secondary outcomes

  1. HCV RNA viral load tests

    Frequency of HCV RNA viral load tests that occur between the first visit over follow-up and the first censoring event

    Time frame: End of follow-up, up to 9 months

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Study locations

1 site
  • AIDS Healthcare Foundation
    Los Angeles, California 90028, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05725109
Lead sponsor
Epividian
Collaborators
Gilead Sciences, AIDS Healthcare Foundation
Responsible party
Sponsor
First posted
Feb 13, 2023
Start date
Jan 16, 2023
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023
Last update
Feb 16, 2024

Study contacts

Michael Wohlfeiler, MD
principal investigator · AIDS Healthcare Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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