An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes

Completed · Not applicable

Conditions studied: Hepatitis C

In brief

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 receiving HCV treatment. Patients giving informed consent will be randomized to a usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health practitioner who will address psychiatric and substance use issues with the goal of enabling patients to undergo effective antiviral therapy. The major outcome of the study is the number of patients in each group who are "cured" with antiviral therapy. Patients in both groups receive current standard of care.

Key facts

Study ID

NCT00722423

Run by

US Department of Veterans Affairs

People needed

364

Starts

2009-05-01

Expected to finish

2014-05-01

Last updated by the study team

2015-10-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• VA Palo Alto Health Care System (154C) — Palo Alto, California, United States
• VA San Diego Healthcare System, San Diego — San Diego, California, United States
• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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