Hepatitis C Treatment in Underserved Populations

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C; Illicit Drug Use
• Intervention / Treatment: Other: Collaborative, multidisciplinary, integrated care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Center for the Study of Hepatitis C, Weill Medical College, Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collaborative multidisciplinary integrated care; Collaborative, multidisciplinary, integrated care for hepatitis C	Other: Collaborative, multidisciplinary, integrated care; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brian Edlin
• Collaborators: Weill Medical College of Cornell University; State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: Brian R. Edlin, MD, Weill Medical College, Cornell University

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 29, 2008
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: integrated care; Substance-Related Disorders; mental health care; chronic hepatitis C; illicit drug use; intensive case management; multidisciplinary care
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: 0308006281