Hepatitis CNCT05725109
Hepatitis C Diagnosis to Treatment Management
An observational study of Hepatitis C, run by Epividian at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C Treatment Alerts in CHORUS™
- How many people
- 1,063 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 17 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18+ years of age
- In care at an AIDS Healthcare Foundation Healthcare Center
- Active, untreated HCV infection
Who cannot join
- <18 years of age
- Patients with active HCV infection who have a current prescription for HCV treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Healthcare Foundation
Los Angeles, California, 90028
About this study
Official title: Hepatitis C Disease Management: Diagnosis to Treatment Alerts in CHORUS™
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.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C Treatment Alerts in CHORUS™, Standard of Care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hepatitis C Treatment Alerts in CHORUS™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: End of follow-up, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start16 Jan 2023
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,063 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, AIDS Healthcare Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Wohlfeiler, MD, Principal investigator, AIDS Healthcare Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725109
- Sponsor's protocol ID
- COL2023-001
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Disease Management: Diagnosis to Treatment Alerts in CHORUS™
- ClinicalTrials.gov ID
- NCT05725109
- Acronym / sponsor ID
- COL2023-001
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,063 participants (actual)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, AIDS Healthcare Foundation
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Period (1/16/2022 to 10/17/2022) | – | Other: Standard of CareAll 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) | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18+ years of age
- In care at an AIDS Healthcare Foundation Healthcare Center
- Active, untreated HCV infection
Key exclusion criteria (2 listed)
- <18 years of age
- Patients with active HCV infection who have a current prescription for HCV treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | After Period (1/16/2023 to 10/17/2023) |
| Standard of CareCHORUS™ 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. | Other | Before Period (1/16/2022 to 10/17/2022) |
Primary outcome
Prescriptions for HCV treatment
Time frame: 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.
1 secondary outcome
HCV RNA viral load tests
Time frame: End of follow-up, up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wohlfeiler, MD principal investigator
AIDS Healthcare Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Epividian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescriptions for HCV treatment (time frame: End of follow-up, up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.