Improving Hepatitis C Treatment in Injection Drug Users

Sponsor

State University of New York - Upstate Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00148031

Collaborator

(none)

111

Enrollment

Locations

Arms

Duration (Months)

55.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection.

Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Liver Diseases Drug Abuse Alcoholism	Drug: Pegylated Interferon and Ribavirin Behavioral: Psychosocial Behavioral: On-site (MMT Clinic) HCV evaluation and treatment Behavioral: Off-site HCV evaluation and treatment	Phase 4

Detailed Description

The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. This will be done by testing an intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs. This intervention will increase access by integrating HCV medical care into a substance abuse treatment program. HCV infection is endemic among IDUs, and is associated with significant medical morbidity. While antiviral treatments are improving rapidly, providing HCV medical care for IDUs remains problematic for a number of reasons. IDUs often do not have adequate access to HCV diagnosis and treatment services, and they may have co-morbid psychiatric diagnoses that affect the ability to withstand the demands of HCV treatment. Therefore, this study will also examine psychiatric disorders and psychiatric symptoms in IDUs who are infected with Hepatitis C virus.

The proposed project is a five-year program consisting of a controlled clinical trial, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT). The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology (GI) Clinic. HCV antibody positive MMT patients (N=220) will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic, or through usual off-site referral to the GI Clinic. The main outcomes will be the rates of attaining SVR and completion of HCV treatment, as well as other measures of HCV-related health outcomes and quality of life. Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study. Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV (SCID) and psychiatric symptom severity will be assessed for depression, mania, anxiety, and psychosis. Drug use measures, and quality of life measures will also be obtained. These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before, during, and after HCV medical care. Finally, the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improving Hepatitis C Treatment in Injection Drug Users

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 On-site (MMT Clinic) HCV evaluation and treatment	Drug: Pegylated Interferon and Ribavirin Both groups with receive the same medical intervention but offered at different locations Behavioral: Psychosocial Assessment of the likelihood of HCV treatment initiation and completion Behavioral: On-site (MMT Clinic) HCV evaluation and treatment Standard HCV treatment with Pegylated Interferon and Ribavirin
Active Comparator: 2 Off-site (GI Clinic) HCV evaluation and treatment	Drug: Pegylated Interferon and Ribavirin Both groups with receive the same medical intervention but offered at different locations Behavioral: Psychosocial Assessment of the likelihood of HCV treatment initiation and completion Behavioral: Off-site HCV evaluation and treatment Standard HCV treatment with Pegylated Interferon and Ribavirin

Arm

Intervention/Treatment

Experimental: 1

On-site (MMT Clinic) HCV evaluation and treatment

Drug: Pegylated Interferon and Ribavirin

Both groups with receive the same medical intervention but offered at different locations

Behavioral: Psychosocial

Assessment of the likelihood of HCV treatment initiation and completion

Behavioral: On-site (MMT Clinic) HCV evaluation and treatment

Standard HCV treatment with Pegylated Interferon and Ribavirin

Active Comparator: 2

Off-site (GI Clinic) HCV evaluation and treatment

Drug: Pegylated Interferon and Ribavirin

Both groups with receive the same medical intervention but offered at different locations

Behavioral: Psychosocial

Assessment of the likelihood of HCV treatment initiation and completion

Behavioral: Off-site HCV evaluation and treatment

Standard HCV treatment with Pegylated Interferon and Ribavirin

Outcome Measures

Primary Outcome Measures

Efficacy of On-site versus Off-site delivery of HCV medical care for methadone maintenance treatment (MMT) patients, as evaluated by the proportion of patients achieving sustained virological response (SVR). [5 years]

Secondary Outcome Measures

psychiatric diagnoses and symptom severity [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-65 years of age.
Enrolled in outpatient methadone maintenance treatment for greater than 3 months.
Hepatitis C RNA positive.
Willingness to accept HCV treatment.
Subject has non-VA (Veteran's Administration) medical insurance or is willing to bear any and all expenses associated with Hepatitis C medical treatment.

Exclusion Criteria:

In need of inpatient drug or alcohol detoxification.
Currently receiving the standard Hepatitis C treatment
Unable to give adequate informed consent.
Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
Male subject who has a female sexual partner who is pregnant or planning to become pregnant at any time during HCV treatment or within 6 months following completion of treatment.
Female subject or male subject who has a female sexual partner who is of child bearing years and not using two medically approved forms of contraception.
Subject has made a commitment to attend residential care psychiatric or drug/alcohol rehabilitation, which would lead to unavailability to attend regularly scheduled medical care and research visits.
Subject did not attend all required screening appointments.
Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Crouse Chemical Dependency Treatment Services	Syracuse	New York	United States	13210
2	SUNY Upstate Medical University - Department of Gastroenterology	Syracuse	New York	United States	13210