Status:
COMPLETED
An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hepatitis C
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective randomized controlled trial comparing two different clinic models for patients with hepatitis C. These patients commonly have mental health problems that are barriers to receivin...
Detailed Description
Impact for Veterans: Treatments are available that can often eliminate the hepatitis C virus (HCV) in infected veterans, resulting in increased life expectancy and quality of life. However, many veter...
Eligibility Criteria
Inclusion
- Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C Polymerase Chain Reaction test that is compatible with chronic hepatitis. (Note: no requirement is made for the presence of abnormal liver function tests).
- Patients may be treatment na ve or have received and failed prior antiviral treatment.
- Age 18-75 years.
- Patient must be able to give informed consent.
- All antiviral treatments are administered according to accept standards of care at each site, with appropriate pre-treatment evaluation and on-treatment management and precautions. Liver biopsies are an accepted standard of care for patients with chronic hepatitis C and are obtained as clinically indicated.
- Patients must meet screening criteria for "high risk" for mental health and substance use problems. "High risk HCV patient" is defined as a patient with Beck Depression Inventory-II\>10 at screening; active drug use indicated by positive urine screen, self-reported use within 6 months on drug use questionnaire or AUDIT-C test \>4, or positive PTSD screen.
Exclusion
- Patient unable or unwilling to participate.
- Decompensated liver disease, with active or recent encephalopathy, variceal bleeding, or ascites or CHILD-PUGH class B or C. (Note: patients with a history of decompensated cirrhosis in the past with resolution who are otherwise antiviral treatment candidates in the opinion of the treating physician will be considered candidates.)
- Other significant near term life-threatening diseases (malignancy, unstable angina, severe chronic obstructive pulmonary disease, pulmonary fibrosis, etc.)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00722423
Start Date
May 1 2009
End Date
May 1 2014
Last Update
October 15 2015
Active Locations (3)
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1
VA Palo Alto Health Care System (154C)
Palo Alto, California, United States, 94304-1290
2
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
3
VA Medical Center, Bronx
The Bronx, New York, United States, 10468