Improving Hepatitis C Treatment in Injection Drug Users

State University of New York - Upstate Medical University

Status and phase: Completed; Phase 4

Conditions: Alcoholism; Hepatitis C; Drug Abuse; Liver Diseases

Treatments: Drug: Pegylated Interferon and Ribavirin; Behavioral: Off-site HCV evaluation and treatment; Behavioral: On-site (MMT Clinic) HCV evaluation and treatment; Behavioral: Psychosocial

Study type: Interventional

Funder types: Other

Identifiers

NCT00148031

SUNY UMU IRB # 4929

R01DA016764 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-65 years of age.
2. Enrolled in outpatient methadone maintenance treatment for greater than 3 months.
3. Hepatitis C RNA positive.
4. Willingness to accept HCV treatment.
5. 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

1. In need of inpatient drug or alcohol detoxification.
2. Currently receiving the standard Hepatitis C treatment
3. Unable to give adequate informed consent.
4. Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
5. 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.
6. 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.
7. 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.
8. Subject did not attend all required screening appointments.
9. Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

1

Experimental group

Description:

On-site (MMT Clinic) HCV evaluation and treatment

Treatment:

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

Drug: Pegylated Interferon and Ribavirin

Behavioral: Psychosocial

2

Active Comparator group

Description:

Off-site (GI Clinic) HCV evaluation and treatment

Treatment:

Drug: Pegylated Interferon and Ribavirin

Behavioral: Off-site HCV evaluation and treatment

Behavioral: Psychosocial