Improving Hepatitis C Treatment in Injection Drug Users
Condition: Hepatitis C; Liver Diseases; Drug Abuse; Alcoholism
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Diseases; Alcoholism; Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Pegylated Interferon and Ribavirin; Psychosocial; On-site (MMT Clinic) HCV evaluation and treatment; Off-site HCV evaluation and treatment
Intervention type(s): Drug; Behavioral; Behavioral; Behavioral
Intervention description(s): Both groups with receive the same medical intervention but offered at different locations; Assessment of the likelihood of HCV treatment initiation and completion; Standard HCV treatment with Pegylated Interferon and Ribavirin; Standard HCV treatment with Pegylated Interferon and Ribavirin
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: behavior modification; health care service utilization; hepatitis C,; injection drug use; therapy compliance; alcoholism; alcohol abuse; prevention; drug abuse; liver disorder; HCV; methadone