Hepatitis C Treatment in Underserved Populations

NCT01717560 | Unknown

• 1 other identifier: 0308006281
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  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

  Weekly up to 96 weeks

Study Arms (1)

Collaborative multidisciplinary integrated care

EXPERIMENTAL

Collaborative, multidisciplinary, integrated care for hepatitis C

Other: Collaborative, multidisciplinary, integrated care

Interventions

Collaborative, multidisciplinary, integrated care 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.

Collaborative multidisciplinary integrated care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brian Edlin: lead
• Weill Medical College of Cornell University: collaborator
• State University of New York - Downstate Medical Center: collaborator

Study Sites (1)

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

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brian R. Edlin, MD

  Weill Medical College, Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine and Public Health

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: October 30, 2012
• Study Start: February 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2020
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

US (1)