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Hepatitis C Treatment in Underserved Populations

NCT ID: NCT01717560

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2020-12-31

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.

Conditions

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Chronic Hepatitis C Illicit Drug Use

Keywords

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chronic hepatitis C illicit drug use Substance-Related Disorders multidisciplinary care integrated care mental health care intensive case management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Collaborative multidisciplinary integrated care

Collaborative, multidisciplinary, integrated care for hepatitis C

Group Type EXPERIMENTAL

Collaborative, multidisciplinary, integrated care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role collaborator

Brian Edlin

OTHER

Sponsor Role lead

Responsible Party

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Brian Edlin

Associate Professor of Medicine and Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brian R. Edlin, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College, Cornell University

Locations

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

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0308006281

Identifier Type: -

Identifier Source: org_study_id