1. Hepatitis B Virus and Hepatitis C Virus Services Offered by Substance Abuse Treatment Programs in the United States E. J. Bini, MD, MPH; S. Kritz MD; L.S. Brown, MD, MPH; J. Robinson, MEd; D. Alderson, MS; P. McAuliffe, MBA, LADC; C. Smith, MD; J. Rotrosen, MD; and the NIDA Clinical Trials Network Infections Study (CTN-0012) Team NYU School of Medicine and VA Hospital, NY, NY; Addiction Research & Treatment Corp, Brooklyn, NY; Nathan Kline Institute, Orangeburg, NY; NYS Psychiatric Institute, NY, NY; Connecticut Renaissance, Inc., Norwalk, CT; Mount Sinai School of Medicine, NY, NY

2. Acknowledgements Research Supported by the National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN; and other Protocol Team members consisting of: Research Supported by the National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN; and other Protocol Team members consisting of: –Randy Seewald, MD; Frank McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD –Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhD –Shirley Irons; Kathlene Tracy, PhD

3. Acknowledgements There are no financial interests or disclosures to report for any of the authors involved in this project There are no financial interests or disclosures to report for any of the authors involved in this project

4. Background HBV and HCV are major causes of morbidity and mortality in the U.S. HBV and HCV are major causes of morbidity and mortality in the U.S. Substance abusers are disproportionally affected by HBV and HCV, and these individuals are largely responsible for sustaining the viral hepatitis epidemic in the U.S. Substance abusers are disproportionally affected by HBV and HCV, and these individuals are largely responsible for sustaining the viral hepatitis epidemic in the U.S. Despite the potential role of substance abuse treatment programs in reducing transmission of viral hepatitis, surprisingly little is known about HBV and HCV health services offered by drug treatment programs in the U.S. Despite the potential role of substance abuse treatment programs in reducing transmission of viral hepatitis, surprisingly little is known about HBV and HCV health services offered by drug treatment programs in the U.S.

5. Primary Objectives To describe the: To describe the: –Specific types of HBV and HCV testing available –Range of HCV-related services offered by substance abuse treatment programs –Availability of HCV treatment To determine whether HCV-related health services differ between: To determine whether HCV-related health services differ between: –Programs that do and those that do not have clear guidelines for hepatitis testing –Methadone and non-methadone programs

6. Study Design and Study Population Study design Study design –Cross-sectional survey –Descriptive & exploratory Study population Study population –Treatment program administrators of drug treatment programs in the U.S.

7. Study Sites New York Node: New York University, New York, NY New York Node: New York University, New York, NY South Carolina Node: Medical University of South Carolina, Charleston, SC South Carolina Node: Medical University of South Carolina, Charleston, SC Florida Node: University of Miami, Coral Gables, FL Florida Node: University of Miami, Coral Gables, FL Great Lakes Node: Wayne State University, Detroit, MI Great Lakes Node: Wayne State University, Detroit, MI Ohio Valley Node: University of Cincinnati, Cincinnati, OH Ohio Valley Node: University of Cincinnati, Cincinnati, OH Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO New England Node: Yale University, New Haven, CT New England Node: Yale University, New Haven, CT Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College of Virginia, Richmond of Virginia, Richmond Pacific Region Node: University of California at Los Angeles, CA Pacific Region Node: University of California at Los Angeles, CA Oregon Node: Oregon Health Sciences University, Portland, OR Oregon Node: Oregon Health Sciences University, Portland, OR Washington Node: University of Washington, Seattle, WA Washington Node: University of Washington, Seattle, WA Long Island Node: NY State Psychiatric Institute, New York, NY Long Island Node: NY State Psychiatric Institute, New York, NY North Carolina Node: Duke University, Raleigh/Durham, NC North Carolina Node: Duke University, Raleigh/Durham, NC Southwest Node: University of New Mexico, Albuquerque, NM Southwest Node: University of New Mexico, Albuquerque, NM Northern New England Node: McLean Hospital, Belmont, MA Northern New England Node: McLean Hospital, Belmont, MA California-Arizona Node: University of California at San Francisco, CA California-Arizona Node: University of California at San Francisco, CA

8. Drug Abuse Treatment Clinical Trials Network Philadelphia Portland Los Angeles Charleston Miami Cincinnati Denver CTN Study Sites Seattle Raleigh/ Durham Long Island Boston San Francisco (CA/AZ Node) New York City Detroit Albuquerque Baltimore/Richmond New Haven 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States!

9. Study Procedures Expedited IRB Approval Expedited IRB Approval Waiver of Informed Consent Waiver of Informed Consent Training for Node Protocol Managers Training for Node Protocol Managers Information Sheet In Lieu of Informed Consent Information Sheet In Lieu of Informed Consent Survey Administration Survey Administration – Paper or electronic – Central data acquisition

10. Administrator Surveys Contact CTP Directors for Treatment Program and Administrator contact information Survey materials mailed to Administrators Ensure IRB approval Administrator completes survey online or mails to Data Center; Administrator enters contact information for Clinicians Node Protocol Manager contacts Administrators that have not responded within two weeks Data Center contacts Administrators that have not completed the survey or Clinician contact information within 30 days Data Center contacts Administrators to resolve any data queries After four weekly attempts, Administrators flagged as non-responders by the Data Center Node Protocol Managers contact non- responder Administrators weekly For Administrators that refuse to participate or still have not responded after two additional weeks, the Node Protocol Manager alerts the Node Principal Investigator

11. RESULTS 319 treatment program administrators surveyed 319 treatment program administrators surveyed 269 individuals (84.3%) from geographically diverse locations in the U.S. returned completed questionnaires 269 individuals (84.3%) from geographically diverse locations in the U.S. returned completed questionnaires

12. Characteristics of the Substance Abuse Treatment Programs Surveyed (1) CharacteristicPercent Corporate structure Private not-for-profit Private for-profit Government Other 78.7% 5.6% 13.4% 2.2% Nature of the program Hospital/Medical School/University Mental Health/Family/Child Services Center Free-Standing Other 13.9% 12.7% 60.7% 12.7% Largest source of revenue County/local grants State funds Medicaid Federal grants Other 17.2% 39.3% 17.6% 12.6% 13.4% Addiction services offered* Inpatient or residential services Outpatient pharmacotherapy Other outpatient services Outreach & support services 55.0% 36.8% 80.2% 87.6% *Responses were not mutually exclusive for this item

13. Characteristics of the Substance Abuse Treatment Programs Surveyed (2) CharacteristicPercent Medical staff (MD, PA, NP, RN, LPN, etc.) 0 1 – 3 4 or more 21.1% 36.4% 42.5% Non-medical staff 0 – 7 8 – 17 18 or more 30.3% 45.2% 24.5% Current patient census 0 1 – 500 501 – 1,000 1,000 or more 2.0% 56.9% 20.4% 20.8% Percent of patients infected with HCV 0 1 – 10 11 – 20 21 or more 9.2% 30.1% 12.1% 48.6%

14. HCV Training of Medical and Non- Medical Staff in Substance Abuse Treatment Programs Ongoing HCV training for clinical staff Both medical and non-medical staff Medical staff only Non-medical staff only Neither medical or non-medical staff 60.5% 6.2% 12.0% 21.3% Proportion of medical staff that had HCV training within the past year 68.4% ± 41.3% Proportion of non-medical staff that had HCV training within the past year 64.4% ± 39.5%

15. HBV Testing Offered by Drug Treatment Programs YesNoDon’t Know HBV surface antigen testing37.7%15.9%46.4% HBV surface antibody testing36.7%16.4%46.9% HBV core antibody testing27.7%21.4%51.0% HBV e antigen testing14.5%32.8%52.7% HBV e antibody testing13.5%33.6%52.9% HBV viral DNA testing7.8%39.3%52.9%

16. HCV Testing and Hepatitis A and B Virus Vaccinations Offered by Drug Treatment Programs YesNoDon’t Know HCV antibody testing52.9%10.0%37.1% HCV RIBA testing13.1%37.4%49.5% HCV qualitative PCR testing10.1%34.3%55.6% HCV quantitative PCR testing8.9%35.5%55.7% HCV genotype testing11.6%36.2%52.2% HAV and HBV vaccination for HCV-infected patients Offered within substance abuse treatment program Offered by contractual agreement with another provider Offered by referral to community resource Not offered 19.3% 3.5% 45.6% 31.7% -------- --------

17. HCV Services Offered by Drug Treatment Programs Patient medical history & physical exam50.0% Patient biological testing34.4% Patient treatment28.9% Patient monitoring35.2% Provider education63.3% Patient education74.1% Patient risk assessment71.9% Patient counseling58.9%

18. Proportion of Substance Abuse Programs That Offered HCV Testing And Hepatitis Vaccination Services According to the Presence or Absence of Clear or Somewhat Clear HCV Testing Guidelines Type of Biological TestingProportion of Programs Offering Testing P-Value Clear or Somewhat Clear Guidelines Exist Clear or Somewhat Clear Guidelines Do Not Exist HCV antibody testing88.7%21.8%<0.001 HCV RIBA testing27.4%7.4%0.004 HCV qualitative PCR testing24.7%5.7%0.007 HCV quantitative PCR testing22.5%3.8%0.004 HCV genotype testing24.7%5.6%0.004 Other hepatitis testing19.2%2.0%0.008 HAV and HBV vaccination to HCV-infected patients74.8%59.8%0.02

19. HCV Services Offered by Methadone and Non- Methadone Substance Abuse Treatment Programs P <0.01 for all comparisons between methadone and non-methadone programs

20. Conclusions Despite the importance of substance abuse in sustaining the viral hepatitis epidemic in the U.S., many substance abuse treatment programs do not offer comprehensive Despite the importance of substance abuse in sustaining the viral hepatitis epidemic in the U.S., many substance abuse treatment programs do not offer comprehensive –HBV or HCV testing –HCV-related health services –HCV treatment –Hepatitis vaccination services Public health interventions to improve access to hepatitis testing, treatment, and prevention for substance abusers are needed Public health interventions to improve access to hepatitis testing, treatment, and prevention for substance abusers are needed