Intravenous drug users have extremely high rates of viral hepatitis including hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) and are the major vector of spread of HCV in the U.S. Although medical treatment of HCV has improved considerably, drug users experience significant barriers to prevention and care services. Integrating hepatitis prevention and health care services into drug abuse treatment programs may increase engagement in and adherence to increasingly effective medical care. This randomized clinical trial will examine the effectiveness of a strategy of Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for opioid users in methadone maintenance treatment compared with standard Testing, Education, and Counseling (TEC). In the HCC model, hepatitis screening and hepatitis A and B vaccination will be done on site and participants receive on site theory-based hepatitis education, counseling, and case management to promote adherence to HCV evaluation;whereas in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary study aims are to assess the impact of the HCC intervention on adherence to HAV and HBV vaccination and attendance at an initial appointment with a HCV care provider. Secondary aims include examining the effect of the intervention on knowledge of hepatitis, risky injection drug use and sexual behaviors, alcohol use;follow-up with later stages of 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. Participants will be 460 (230 from each of two sites) methadone maintenance patients. They will be randomly assigned to either HCC or TEC. We hypothesize that those receiving on site HCC will be more likely to: a) adhere to vaccination for HAV and/or HBV, as indicated;and b) for those who test HCV positive, to adhere to referral to an initial diagnostic evaluation with a HCV provider than the TEC group. Assessment will occur at baseline, 3, 9, and 12 months. Study participants will be recruited from methadone maintenance treatment at two sites, increasing the generalizability of the study. Findings from this study would be of immense value to health policy planners and would inform the implementation of initiatives to improve hepatitis services targeted to drug users.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Research Project (R01)
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Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Denisco, Richard A
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University of California San Francisco
Schools of Medicine
San Francisco
United States
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