1	SAMHSA Hepatitis A and B Vaccine Initiative For Patients with Substance Use Disorders at Risk for Liver Failure
2	Specific Aims Establish collaborative agreements to enhance hepatitis vaccinations for minority patients at risk for HIV and/or hepatitis C Work with three programs types: opioid treatment programs, office-based buprenorphine treatment and SAMHSA minority AIDS initiative (MAI) grantees Evaluate vaccine distribution and outcome Stratify by program type and demographics
3	Collaborative agreements Include: established programs with active assessment and management of HIV and HCV that include hepatitis vaccination OTPs (25) Office-based buprenorphine treatment (10) CSAT/CSAP MAI TCE grantees (25) Establish participation by invitation Establish contacts/agreement to participate Collect standard operating procedures
4	Contracts Vaccine distribution contract Hepatitis A/B vaccine (Twinrix) to 60 sites Track distribution patterns and utilization Evaluation contracts Describe use within OTPs, and MAI grantees Connect with buprenorphine prescribing clinicians identified within Special Programs of National Significance
5	Evaluation Strategy Descriptive: Collect operating procedures Define current vaccine acquisition process Define current data system for tracking vaccine delivery Define current vaccine assessment and immunization practice Establish vaccination work process within different treatment settings Describe connectivity between immunization and substance abuse treatment programs
6	Evaluation Strategy
7	Analysis Total potential population: 10,000 – 15,000 200 – 400 patients immunized per site Stratified Population Groups Demographics Gender, age group, ethnicity, program setting Known Serological and Disease status HIV, HCV, Substance Use Disorder (SUD) diagnosis Outcome % in each group completing 1, 2 and 3 shots Safety and adverse event issues reflected in VAERS
8	POINT OF CONTACT Center for Substance Abuse Treatment Division of Pharmacological Therapies Kenneth Hoffman (240) 276-2701 Ray Hylton (240) 276-2709 Tom Kresina (240) 276-2713 Robert Lubran (240) 276-2714