2. Hepatitis C Virus Services Offered by Substance Abuse Treatment Programs in the U.S. 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

3. ABSTRACT ABSTRACT Background: Although substance abuse treatment programs are an important point of contact to provide health services to diagnose, treat, and prevent transmission of hepatitis C (HCV) viral infection, little is known about the availability of these services in substance abuse programs. This study evaluated the prevalence and spectrum of HCV services offered by drug treatment programs in the U.S. Methods: We conducted a questionnaire-based survey of drug treatment programs within the National Drug Abuse Treatment Clinical Trials Network. Completed questionnaires were received from 269 (84.3%) of the 319 program administrators. Results: Although 78.7% of programs reported that they offered ongoing hepatitis training for clinical staff, only a minority of programs offered testing for HCV antibodies (52.9%), HCV qualitative PCR (10.1%), HCV quantitative PCR (8.9%), and HCV genotyping (11.6%). Hepatitis A and B vaccinations were offered by 68.3% of programs, either on site (19.3%) or via referral (49.1%). Programs having clear guidelines for hepatitis testing were significantly more likely to offer each of the hepatitis tests as compared with those that did not have clear guidelines. Only 28.9% of programs offered HCV treatment either on-site or via referral. Conclusions: Despite the importance of substance abuse in sustaining the hepatitis epidemic in the U.S., many substance abuse treatment programs do not offer comprehensive HCV and hepatitis vaccination services. Public health interventions to improve access to hepatitis testing, treatment, and prevention for substance abusers are needed.

4. 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

5. Drug Abuse Treatment Clinical Trials Network Philadelphia Portland Los Angeles Charleston Miami Cincinnati Denver CTN 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!

6. 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

7. STUDY RATIONALE STUDY RATIONALE HCV is a major cause of morbidity and mortality in the U.S. HCV is a major cause of morbidity and mortality in the U.S. Substance abusers are disproportionally affected by HCV, and these individuals are largely responsible for sustaining the HCV epidemic in the U.S. Substance abusers are disproportionally affected by HCV, and these individuals are largely responsible for sustaining the HCV 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 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 HCV health services offered by drug treatment programs in the U.S.

8. PRIMARY OBJECTIVES TO DESCRIBE THE: TO DESCRIBE THE: –Range of HCV-related services offered by substance abuse treatment programs –Specific types of HCV testing available –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 do not have clear guidelines for hepatitis testing –Methadone and non-methadone programs

9. DESIGN AND 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.

10. ETHICAL, REGULATORY & ADMINISTRATIVE CONSIDERATIONS Expedited IRB Approval Expedited IRB Approval Waiver of Informed Consent Waiver of Informed Consent Training for Node Protocol Managers Training for Node Protocol Managers

11. STUDY PROCEDURES STUDY PROCEDURES Node Protocol Managers 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

12. 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

13. 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

14. CHARACTERISTICS OF THE SUBSTANCE ABUSE TREATMENT PROGRAMS SURVEYED 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

15. CHARACTERISTICS OF THE SUBSTANCE ABUSE TREATMENT PROGRAMS SURVEYED 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%

16. 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%

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. 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% -------- --------

19. PROPORTION OF SUBSTANCE ABUSE PROGRAMS THAT OFFERED HCV TESTING AND HEPATITIS VACCINATION SERVICES ACCORDING TO THE PRESENCE OR ABSENCE OF CLEAR OR SOMEWHAT CLEAR 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

20. HCV SERVICES OFFERED BY METHADONE AND NON-METHADONE SUBSTANCE ABUSE TREATMENT PROGRAMS P <0.01 for all comparisons between methadone and non-methadone programs

21. CONCLUSIONS Despite the importance of substance abuse in sustaining the HCV epidemic in the U.S., many substance abuse treatment programs do not offer comprehensive Despite the importance of substance abuse in sustaining the HCV epidemic in the U.S., many substance abuse treatment programs do not offer comprehensive –HCV-related health services –HCV testing –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.