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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA020781-03
Application #
7434521
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Brady, Thomas M
Project Start
2006-09-30
Project End
2011-04-30
Budget Start
2008-05-01
Budget End
2009-04-30
Support Year
3
Fiscal Year
2008
Total Cost
$331,144
Indirect Cost
Name
University of California San Francisco
Department
Psychiatry
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Schackman, Bruce R; Gutkind, Sarah; Morgan, Jake R et al. (2018) Cost-effectiveness of hepatitis C screening and treatment linkage intervention in US methadone maintenance treatment programs. Drug Alcohol Depend 185:411-420
McKnight, Courtney; Shumway, Martha; Masson, Carmen L et al. (2017) Perceived discrimination among racial and ethnic minority drug users and the association with health care utilization. J Ethn Subst Abuse 16:404-419
Dhingra, Lara; Perlman, David C; Masson, Carmen et al. (2015) Longitudinal analysis of pain and illicit drug use behaviors in outpatients on methadone maintenance. Drug Alcohol Depend 149:285-9
Larios, Sandra E; Masson, Carmen L; Shopshire, Michael S et al. (2014) Education and counseling in the methadone treatment setting improves knowledge of viral hepatitis. J Subst Abuse Treat 46:528-31
Perlman, David C; Jordan, Ashly E; McKnight, Courtney et al. (2014) Viral hepatitis among drug users in methadone maintenance: associated factors, vaccination outcomes, and interventions. J Addict Dis 33:322-31
Masson, Carmen L; Rainey, Petrie M; Moody, David E et al. (2014) Effects of HCV seropositive status on buprenorphine pharmacokinetics in opioid-dependent individuals. Am J Addict 23:34-40
Masson, Carmen L; Delucchi, Kevin L; McKnight, Courtney et al. (2013) A randomized trial of a hepatitis care coordination model in methadone maintenance treatment. Am J Public Health 103:e81-8
Manuel, Jennifer K; Newville, Howard; Larios, Sandra E et al. (2013) Confidentiality protections versus collaborative care in the treatment of substance use disorders. Addict Sci Clin Pract 8:13
Dhingra, Lara; Masson, Carmen; Perlman, David C et al. (2013) Epidemiology of pain among outpatients in methadone maintenance treatment programs. Drug Alcohol Depend 128:161-5
Jordan, Ashly E; Masson, Carmen L; Mateu-Gelabert, Pedro et al. (2013) Perceptions of drug users regarding hepatitis C screening and care: a qualitative study. Harm Reduct J 10:10

Showing the most recent 10 out of 12 publications