Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

Completed · Not applicable

Conditions studied: Hepatitis C, Depression, PTSD, Substance Use Disorder, Fibrosis

In brief

To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.

Key facts

Study ID

NCT02648022

Run by

VA Office of Research and Development

People needed

83

Starts

2012-01-01

Expected to finish

2014-02-01

Last updated by the study team

2016-05-20

Who can join

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

You may qualify if…

• Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
• All patients 18 and 75 years old with confirmed HCV infection
• Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
• Screening measures and cutoffs for inclusion were depression:
• Beck Depression Inventory: (BDI) > 10
• Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
• PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
• Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen

You may not qualify if…

• Lacked a confirmed test of HCV RNA
• Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
• Had Hepatitis B (HBV) co-infection
• Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
• Had other significant near term life-threatening diseases
• Were treatment non-responders with pegylated Interferon plus ribavirin

Where it is running

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States

Full record on ClinicalTrials.gov

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