HIV and Hepatitis Care Coordination in Methadone Treatment

Brief Summary

Official Title: “HIV and Hepatitis Care Coordination in Methadone Treatment”

This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
  • Study Primary Completion Date: June 2011

Detailed Clinical Trial Description

In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.

Interventions Used in this Clinical Trial

  • Behavioral: Testing, Education, & Counseling (TEC)
    • Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral.
  • Behavioral: Hepatitis Care Coordination (HCC)
    • HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Testing, Education, & Counseling (TEC)
    • HIV and hepatitis screening is done on-site, but vaccination and medical care will be provided by off-site referral. HIV and Hepatitis, Testing, Education, & Counseling (TEC) participants will receive standard HIV and hepatitis education & counseling. TEC participants will not receive case management services.
  • Experimental: Hepatitis Care Coordination (HCC)
    • Participants will receive on-site HIV and viral hepatitis screening. Hepatitis A and B combination vaccination will be provided on-site. Participants will receive on-site theory-based HIV and hepatitis education, counseling, and 6 months of case management to promote adherence to HIV and HCV evaluation.

Outcome Measures for this Clinical Trial

Primary Measures

  • Vaccination adherence visits
    • Time Frame: 30 days
      Safety Issue?: No
  • Health Care Utilization Survey
    • Time Frame: 12 months
      Safety Issue?: No
  • Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
    • Time Frame: 12 months
      Safety Issue?: No

Secondary Measures

  • Hepatitis A Knowledge Test
    • Time Frame: post-intervention & 90 days
      Safety Issue?: No
  • Hepatitis B Knowledge Test
    • Time Frame: post-intervention & 90 days
      Safety Issue?: No
  • Hepatitis C Knowledge Test
    • Time Frame: post-intervention & 90 days
      Safety Issue?: No
  • HIV Knowledge Test
    • Time Frame: post-intervention & 90 days
      Safety Issue?: No
  • Risk Behavior Survey
    • Time Frame: 3 months, 9 months, 12 months
      Safety Issue?: No
  • Addiction Severity Index
    • Time Frame: 3 months, 9 months, 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • >=18 years of age
  • be able to provide informed consent
  • agree to participate in hepatitis/HIV intervention
  • expect to be available to participate in the study for the entire duration of the study
  • HCV negative, of unknown HCV status, or have not received any previous medical care for HCV

Exclusion Criteria

  • have already had a formal hepatitis C evaluation
  • are obtaining medical care for hepatitis C
  • not interested in obtaining medical care for hepatitis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carmen L Masson, Ph.D., Principal Investigator, Univerisity of California, San Francisco, Dept. of Psychiatry
    • David Perlman, MD, Principal Investigator, Chemical Dependency Institute at Beth Israel Medical Center

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00608192