HCV-Related Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network

1. HCV-Related Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network Lawrence S. Brown Jr., MD, MPH, FASAM Addiction Research and Treatment Corporation, Brooklyn, NY; and Weill Medical College, Cornell University, New York, NY Oral Presentation at the American Association for the Treatment of Opioid Dependence Atlanta, GA - April 25, 2006

2. ACKNOWLEDGEMENTS PATIENTS AND STAFF OF THE ADDICTION RESEARCH AND TREATMENT CORPORATION, A COMMUNITY-BASED SUBSTANCE ABUSE SERVICE AGENCY

3. ACKNOWLEDGEMENTS • Research Supported by National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046)with the NIDA CTN and Protocol Team members consisting of: • Steven Kritz, MD; John Rotrosen, MD; Jim Robinson, MEd; Edmund Bini, MD, MPH; Jeff Goldsmith, MD; Dennis McCarty, PhD; Donald Calsyn, PhD; Patrick McAuliffe, MBA, LADC; Karen Reese, CAC-AD • Shirley Irons; Sherryl Baker, PhD; Kathlene Tracy, PhD

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

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

6. STUDY RATIONALE • HCV: the major cause of hepatic failure requiring liver transplantation in the US • Substance use: a major vehicle for HCV transmission • Scope of, and challenges to identifying, counseling and treating persons with HCV in substance abuse treatment will assist in developing effective interventions

7. PREVIOUS RESEARCH • Focused on a single treatment program or a local group of programs • The 2 national multi-site assessments did not include associations to state policies, guidelines of regulations or information from clinicians

8. IMPORTANT ABREVIATIONS • HCV = Hepatitis C Virus • CTP = Community Treatment Program • CTN = Clinical Trials Network • SOP = Standard Operating Procedures • IRB = Institutional (Human Subject) Review Board

9. IMPORTANT DEFINITIONS Service A Service A Service A Service B Service C Service D Service E

10. IMPORTANT TERMS • Treatment Program vs. NIDA CTN CTP • Services Assessed • Provider Education • Patient Education • Patient Risk Assessment • Patient Counseling • Patient Medical History & Physical Exam • Patient Biological Testing • Patient Treatment • Patient Monitoring

11. PRIMARY OBJECTIVES • TO DESCRIBE: • Range of HCV-Related Services Available • CTP Characteristics (funding, staffing) • Perceived Barriers to Providing HCV-Related Services • State Policies, Regulations, or Guidelines • TO EXAMINE ASSOCIATIONS BETWEEN: • CTPs’ Availability of Selected HCV-Related Services and State Policies, Guidelines, Regulations

12. DESIGN AND POPULATION • STUDY DESIGN • 2 Cross-sectional Surveys • Descriptive & Exploratory • STUDY POPULATION • CTP Administrators • Administrators of State Health Departments and State Substance Abuse Agencies

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

14. STUDY PROCEDURES • Node Protocol Managers • Information Sheet In Lieu of Informed Consent • Survey Administration • Paper or Electronic • Central data acquisition

15. Administrator Surveys Administrator completes survey online or mails to Data Center; Administrator enters contact information for Clinicians Contact CTP Directors for Treatment Program and Administrator contact information Ensure IRB approval Survey materials mailed to Administrators Data Center contacts Administrators that have not completed the survey or Clinician contact information within 30 days Node Protocol Manager contacts Administrators that have not responded within two weeks 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

16. State Surveys Project Manager enters State Administrator contact information into the Data Center system Data Center mails survey material to State Administrators State Administrator completes the survey online or mails to Data Center After four weekly attempts to contact State Administrators, the Project Manager flags them as non-responders Project Manager contacts State Administrators that have not completed survey within 30 days Data Center reviews data and communicates any issues to Project Manager Project Manager contacts State Administrators to resolve data queries

17. RESULTS • 269 administrators responded (84%) out of 319 substance abuse program administrators surveyed, from 95 CTPs in the NIDA CTN, covering 26 states & DC • 1723 clinicians of 2210 targeted (78%) • At least one substance abuse or health department administrator from 48 states and the District of Columbia (96%)

18. Characteristics of Treatment Programs *Percentages do not total 100% due to rounding and non-respondents

19. Characteristics of Treatment Programs *Percentages do not total 100% due to rounding and non-respondents # Responses were not mutually exclusive for this item

20. HCV-RELATED SERVICES IN SUBSTANCE ABUSETREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269)

21. PRELIMINARY RESULTS: TREATMENT PROGRAM CHARACTERISTICS BY HCV-RELATED PATIENT COUNSELING SERVICES

22. PRELIMINARY RESULTS: Relationship Between State Policy & TP HCV Patient Risk Assessment • State Administrator Respondents • 53% Reported Guidelines/Regulations/Policies • TP Administrator Respondents • In States With Guidelines/Regulations/Policies: 79% of Programs Provide the Service • In States Without Guidelines/Regulations/Policies: 65% of Programs Provide the Service

23. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) HCV Biological Testing • State Administrator Respondents • 26% Reported Guidelines/Regulations/Policies • TP Administrator Respondents • In States With Guidelines/Regulations/Policies: 43% Provide the Service • In States Without Guidelines/Regulations/Policies: 32% Provide the Service

24. RELATIONSHIP BETWEEN STATE POLICIES, GUIDELINES, & REGULATIONS AND HCV-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS

25. STUDY LIMITATIONS • Generalizability of Results • Consistent with 2 previous published assessments • Does not include utilization, cost, efficiency, or effectiveness of HCV-related services • Hypothesis generating

26. SUMMARY • Most HCV-related services are offered by: • a substantial proportion of private not-for-profit, for-profit, and public agencies • a substantial proportion of substance abuse treatment programs of all sizes • Staffing patterns (medical and non-medical) are quite varied

27. SUMMARY • There is substantial variation in the availability of HCV-related services in CTN treatment programs • The availability of most services appeared to be unrelated to state policies, guidelines, or regulations. • The availability of counseling, treatment and monitoring appeared to be associated with the presence state guidelines, policies and mandates

28. BOTTOM LINE • Many treatment programs offer an array of HCV-related services • A significant number of programs offer no HCV-related services. • State guidance appears to have some influence on the availability of HCV-related services • A number of hypotheses & opportunities remain to be proposed, pursued, and answered • These are preliminary results of a larger study

29. BOTTOM LINE • Significant opportunities exist to explore other associations between the HCV-related services offered and • Other Substance Abuse Treatment Program Characteristics • CTP Characteristics (funding, staffing) • Clinician Characteristics (training, knowledge, behavior) • Opinions • Perceived Barriers to Providing Infection-Related Services

30. FOR MORE INFORMATION ABOUT THIS STUDY • AT THIS MEETING • Poster- P4- • AT OTHER PROFESSIONAL MEETINGS • American Society on Addiction Medicine, San Diego, CA 2006 • College on Problems of Drug Dependence, Scottsdale, AZ, 2006 • PEER-REVIEWED PUBLICATIONS • Accepted by Journal of Substance Abuse Treatment • CONTACTING STUDY PERSONNEL • Dr. Brown, the Principal Investigator: lbrown@artcny.org • Steven Kritz, MD – the Project Director: skritz@artcny.org