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Clinical Trials/NCT00608192
NCT00608192
Completed
Not Applicable

HIV and Hepatitis Care Coordination in Methadone Treatment

University of California, San Francisco2 sites in 1 country489 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatitis, Viral, Human
Sponsor
University of California, San Francisco
Enrollment
489
Locations
2
Primary Endpoint
Vaccination adherence visits
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
June 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Vaccination adherence visits

Time Frame: 30 days

Health Care Utilization Survey

Time Frame: 12 months

Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases

Time Frame: 12 months

Secondary Outcomes

  • Hepatitis A Knowledge Test(post-intervention & 90 days)
  • Hepatitis B Knowledge Test(post-intervention & 90 days)
  • Hepatitis C Knowledge Test(post-intervention & 90 days)
  • HIV Knowledge Test(post-intervention & 90 days)
  • Risk Behavior Survey(3 months, 9 months, 12 months)
  • Addiction Severity Index(3 months, 9 months, 12 months)

Study Sites (2)

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