摘要:Objectives. We evaluated the efficacy of a hepatitis care coordination intervention to improve linkage to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and clinical evaluation of hepatitis C virus (HCV) infection among methadone maintenance patients. Methods. We conducted a randomized controlled trial of 489 participants from methadone maintenance treatment programs in San Francisco, California, and New York City from February 2008 through June 2011. We randomized participants to a control arm (n = 245) and an intervention arm (n = 244), which included on-site screening, motivational-enhanced education and counseling, on-site vaccination, and case management services. Results. Compared with the control group, intervention group participants were significantly more likely (odds ratio [OR] = 41.8; 95% confidence interval [CI] = 19.4, 90.0) to receive their first vaccine dose within 30 days and to receive an HCV evaluation within 6 months (OR = 4.10; 95% CI = 2.35, 7.17). A combined intervention adherence outcome that measured adherence to HAV–HBV vaccination, HCV evaluation, or both strongly favored the intervention group (OR = 8.70; 95% CI = 5.56, 13.61). Conclusions. Hepatitis care coordination was efficacious in increasing adherence to HAV–HBV vaccination and HCV clinical evaluation among methadone patients. Viral hepatitis is a major public health problem among drug users in the United States. Drug users are at high risk of infection with hepatitis A, B, and C viruses (HAV, HBV, and HCV, respectively) through unsterile injection practices and high-risk sexual activity. 1–3 HCV infection can be acquired rapidly by injection drug users, with prevalence rates of 70% or higher among recent-onset injectors. 4,5 Cirrhosis, hepatocellular carcinoma, and death are important sequelae of HCV and chronic HBV infection. 6,7 Superimposed HBV and HAV infection may exacerbate liver disease among those with chronic HCV infection. 8 HIV infection can accelerate disease progression in HCV- and HBV-infected persons. 9–11 Given that a significant proportion of this population remains at risk for these infections, HAV–HBV vaccination programs that effectively engage drug users are needed. 2,12 Treatment options for HCV are rapidly improving with the introduction of direct-acting antivirals (e.g., telaprevir and boceprevir) and the prospect of interferon-free regimens. 13–16 The integration of primary medical care and case management services within drug treatment programs has been associated with increased utilization of outpatient health care services among HIV- and HCV-seropositive drug users. Studies have found increased rates of the use of HIV/AIDS- and HCV-related medical care services in the methadone treatment setting 17–19 ; however, most drug treatment programs do not have the infrastructure to provide on-site HCV treatment. 20 Despite advances in HCV treatment, many HCV-positive drug users are not engaged in HCV care, 21,22 and many drug users experience missed opportunities for HAV and HBV vaccination. 2,23 Drug users experience multiple complex individual, social, and structural barriers to HCV evaluation and treatment. Barriers include lack of knowledge about available effective treatments, low perceived risk of potential long-term adverse health consequences, fear of possible side effects of treatment, high treatment costs, lack of insurance, negative peer norms regarding HCV medications, medical mistrust, and potential provider concerns about treating active drug users. 24–31 As has been observed for HIV infection, with HCV infection there is a cascade of care, with decreasing proportions of infected persons knowing their status, having had a clinical evaluation, being engaged in care, being on treatment, completing treatment, and having an optimal virological response. 21,30,32 HCV drug efficacy trials focus on optimizing outcomes among those treated, whereas adherence interventions frequently focus on assisting individuals to complete initiated therapy. For drug users with HCV infection, the initial steps in the cascade of care, including screening, identifying those HCV positive, and engaging infected persons in care, remain a substantial gap. 21 Care coordination approaches such as case management and patient navigation services have shown promise in engaging and retaining patients in cancer screening and care and have been used in HIV primary care with promising but inconsistent results. 33–39 There is a need for rigorously designed research to examine the efficacy of care coordination approaches such as case management and patient navigation as a strategy for improving the efficiency of the HCV cascade of care. We evaluated the impact of a hepatitis care coordination model integrated in the methadone maintenance treatment (MMT) setting on the following primary outcomes: (1) receipt of the first dose of HAV–HBV vaccine and (2) adherence to an initial appointment with a hepatitis C health care provider. We hypothesized that hepatitis care coordination, including on-site screening, education and counseling, motivational interviewing, on-site vaccination, and case management, would increase rates of adherence to HAV–HBV vaccination and initial appointment with a hepatitis C health care provider more than a control intervention that reflected standard recommendations for the care of drug users. 40