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Hepatitis C Treatment in Underserved Populations

Primary Purpose

Chronic Hepatitis C, Illicit Drug Use

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative, multidisciplinary, integrated care
Sponsored by
Brian Edlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring chronic hepatitis C, illicit drug use, Substance-Related Disorders, multidisciplinary care, integrated care, mental health care, intensive case management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for the Study of Hepatitis C, Weill Medical College, Cornell University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collaborative multidisciplinary integrated care

Arm Description

Collaborative, multidisciplinary, integrated care for hepatitis C

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

completion of medical and psychiatric evaluation for antiviral therapy
initiation of antiviral therapy
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.)
completion of antiviral therapy
levels of alcohol and illicit drug use
Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
entry into treatment for substance use
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
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
neuropsychiatric side effects, including depression and hostility/irritability
Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
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)
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
reinfection
Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.

Full Information

First Posted
April 29, 2008
Last Updated
October 25, 2012
Sponsor
Brian Edlin
Collaborators
Weill Medical College of Cornell University, State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01717560
Brief Title
Hepatitis C Treatment in Underserved Populations
Official Title
Hepatitis C Treatment in Underserved Populations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian Edlin
Collaborators
Weill Medical College of Cornell University, State University of New York - Downstate Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Illicit Drug Use
Keywords
chronic hepatitis C, illicit drug use, Substance-Related Disorders, multidisciplinary care, integrated care, mental health care, intensive case management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collaborative multidisciplinary integrated care
Arm Type
Experimental
Arm Description
Collaborative, multidisciplinary, integrated care for hepatitis C
Intervention Type
Other
Intervention Name(s)
Collaborative, multidisciplinary, integrated care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
Description
SVR is measured 24 weeks after completion of antiviral treatment
Time Frame
24 weeks after completion of antiviral treatment
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
adherence to antiviral therapy
Description
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.)
Time Frame
Weekly up to 48 weeks
Title
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.)
Title
levels of alcohol and illicit drug use
Description
Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
Time Frame
Weekly up to 96 weeks
Title
entry into treatment for substance use
Description
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Time Frame
Monthly up to 24 months
Title
entry into treatment for another unaddressed medical or psychiatric condition
Description
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Time Frame
Monthly up to 24 months
Title
neuropsychiatric side effects, including depression and hostility/irritability
Description
Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
Time Frame
Monthly up to 72 weeks
Title
treatment-limiting systemic, hematologic, or other side effects
Description
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)
Time Frame
Weekly up to 72 weeks
Title
other adverse events or adverse effects
Description
Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
Time Frame
Monthly up to 72 weeks
Title
reinfection
Description
Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.
Time Frame
Quarterly up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian R. Edlin, MD
Organizational Affiliation
Weill Medical College, Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Hepatitis C Treatment in Underserved Populations

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