Status:
TERMINATED
Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital
Lead Sponsor:
National Opinion Research Center
Collaborating Sponsors:
Grady Health System
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid ...
Detailed Description
EZ-C's purpose is to determine the effectiveness of patient navigation services during treatment of hepatitis C compared to usual care among opioid substitution therapy (OST) and active injecting drug...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient is antibody positivity for HCV, defined as;
- Patients identified in the Grady Memorial Hospital Hepatitis C registry who have tested antibody positive for HCV and have not received additional RNA confirmatory or genotype testing; or
- Patients who tested antibody positive for HCV through Grady Liver Clinics allied community-based testing organizations.
- Patient is a member of one of two sub-population groups of interest, people on opioid substitution therapy (OST) or people who currently inject drugs, defined as;
- A pharmaceutical or diagnostic indicator of OST or morbidity resulting from injecting drug use identified in the patient's electronic health record (EHR), or
- Referral for HCV care from an Atlanta area syringe exchange program
- Eligible for treatment. To be eligible for treatment, patients must
- Meet the above criteria,
- Complete care milestones of viral load/RNA confirmation, viral genotyping, clinical evaluation, and non-invasive fibrosis stages;
- Exhibit a detectable viral load, and an HCV genotypes of 1 or 4
- Note: Enrolled patients infected with genotypes other than 1 or 4 will be treated according to usual care practices of the Grady Liver Clinic.
- Exclusion criteria. Patients who meet criteria 1 and 2 will be excluded from the study if
- They have already received confirmatory RNA or genotype testing
- Have been offered treatment by the Grady Liver Clinic and refused
- Have a comorbidity that the Grady Liver Clinic determines would contraindicate treatment
Exclusion
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03441542
Start Date
July 23 2018
End Date
February 15 2019
Last Update
May 25 2022
Active Locations (1)
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1
Grady Health System
Atlanta, Georgia, United States, 30315