Hepatitis C Treatment in Underserved Populations

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

Detailed Description
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This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.

Official Title
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Hepatitis C Treatment in Underserved Populations

Conditions
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Chronic Hepatitis C, Illicit Drug Use

Intervention / Treatment
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* Other: Collaborative, multidisciplinary, integrated care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Used heroin, cocaine, or injected other drugs for at least 1 year Have used heroin, cocaine and/or methamphetamine within the last 30 days Test positive for HCV antibody Are interested in being evaluated for HCV treatment Exclusion Criteria: Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative multidisciplinary integrated care<br>Collaborative, multidisciplinary, integrated care for hepatitis C | Other: Collaborative, multidisciplinary, integrated care<br>* Collaborative, multidisciplinary, integrated care for hepatitis C multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy. | SVR is measured 24 weeks after completion of antiviral treatment | 24 weeks after completion of antiviral treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of medical and psychiatric evaluation for antiviral therapy |  | Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases. | 
| initiation of antiviral therapy |  | Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases. | 
| adherence to antiviral therapy | Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.) | Weekly up to 48 weeks | 
| completion of antiviral therapy |  | Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.) | 
| levels of alcohol and illicit drug use | Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up | Weekly up to 96 weeks | 
| entry into treatment for substance use | Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy | Monthly up to 24 months | 
| entry into treatment for another unaddressed medical or psychiatric condition | Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy | Monthly up to 24 months | 
| neuropsychiatric side effects, including depression and hostility/irritability | Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter | Monthly up to 72 weeks | 
| treatment-limiting systemic, hematologic, or other side effects | Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment) | Weekly up to 72 weeks | 
| other adverse events or adverse effects | Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff | Monthly up to 72 weeks | 
| reinfection | Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy. | Quarterly up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis C, illicit drug use, Substance-Related Disorders, multidisciplinary care, integrated care, mental health care, intensive case management