Hepatitis C Treatment in Underserved Populations

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Brian Edlin, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01717560
First received: April 29, 2008
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Chronic Hepatitis C
Illicit Drug Use
Other: Collaborative, multidisciplinary, integrated care

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatitis C Treatment in Underserved Populations

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy. [ Time Frame: 24 weeks after completion of antiviral treatment ] [ Designated as safety issue: No ]
    SVR is measured 24 weeks after completion of antiviral treatment


Secondary Outcome Measures:
  • completion of medical and psychiatric evaluation for antiviral therapy [ Time Frame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases. ] [ Designated as safety issue: No ]
  • initiation of antiviral therapy [ Time Frame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases. ] [ Designated as safety issue: No ]
  • adherence to antiviral therapy [ Time Frame: Weekly up to 48 weeks ] [ Designated as safety issue: No ]
    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.)

  • completion of antiviral therapy [ Time Frame: 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.) ] [ Designated as safety issue: No ]
  • levels of alcohol and illicit drug use [ Time Frame: Weekly up to 96 weeks ] [ Designated as safety issue: No ]
    Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up

  • entry into treatment for substance use [ Time Frame: Monthly up to 24 months ] [ Designated as safety issue: No ]
    Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy

  • entry into treatment for another unaddressed medical or psychiatric condition [ Time Frame: Monthly up to 24 months ] [ Designated as safety issue: No ]
    Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy

  • neuropsychiatric side effects, including depression and hostility/irritability [ Time Frame: Monthly up to 72 weeks ] [ Designated as safety issue: Yes ]
    Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter

  • treatment-limiting systemic, hematologic, or other side effects [ Time Frame: Weekly up to 72 weeks ] [ Designated as safety issue: Yes ]
    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)

  • other adverse events or adverse effects [ Time Frame: Monthly up to 72 weeks ] [ Designated as safety issue: Yes ]
    Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff

  • reinfection [ Time Frame: Quarterly up to 10 years ] [ Designated as safety issue: No ]
    Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.


Estimated Enrollment: 30
Study Start Date: February 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717560

Locations
United States, New York
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Brian Edlin
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
  More Information

No publications provided

Responsible Party: Brian Edlin, Associate Professor of Medicine and Public Health, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01717560     History of Changes
Other Study ID Numbers: 0308006281
Study First Received: April 29, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
chronic hepatitis C
illicit drug use
Substance-Related Disorders
multidisciplinary care
integrated care
mental health care
intensive case management

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 23, 2014