Clinical trial NCT01717560: Hepatitis C Treatment in Underserved Populations
Official title: Hepatitis C Treatment in Underserved Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: State University of New York - Downstate Medical Center
First posted: 2012-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
timeFrame: 24 weeks after completion of antiviral treatment
Secondary outcomes:
measure: completion of medical and psychiatric evaluation for antiviral therapy
timeFrame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
measure: initiation of antiviral therapy
timeFrame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
measure: adherence to antiviral therapy
timeFrame: Weekly up to 48 weeks
measure: completion of antiviral therapy
timeFrame: 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.)
measure: levels of alcohol and illicit drug use
timeFrame: Weekly up to 96 weeks
measure: entry into treatment for substance use
timeFrame: Monthly up to 24 months
measure: entry into treatment for another unaddressed medical or psychiatric condition
timeFrame: Monthly up to 24 months
measure: neuropsychiatric side effects, including depression and hostility/irritability
timeFrame: Monthly up to 72 weeks
measure: treatment-limiting systemic, hematologic, or other side effects
timeFrame: Weekly up to 72 weeks
measure: other adverse events or adverse effects
timeFrame: Monthly up to 72 weeks
measure: reinfection
timeFrame: Quarterly up to 10 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for the Study of Hepatitis C, Weill Medical College, Cornell University
state: New York
Study officials:
affiliation: Weill Medical College, Cornell University
name: Brian R. Edlin, MD
role: PRINCIPAL_INVESTIGATOR
References: