The NIDA Clinical Trials Network Infections Study (CTN-0012)

1. STATE POLICIES & AVAILABILITY OF INFECTION-RELATED SERVICES IN SUSTANCE ABUSE TREATMENT PROGRAMS – CONNECTED AT THE HIP? The NIDA Clinical Trials Network Infections Study (CTN-0012)

2. Lawrence S. Brown, Jr., MD, MPH, FASAM; Steven Kritz, MD; John Rotrosen, MD; Jeff Goldsmith, MD; Edmund Bini, MD, MPH; Jim Robinson, MEd Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, Cincinnati, OH; Nathan Kline Institute, Orangeburg, NY

3. ACKNOWLEDGEMENTS • Research Supported by 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; Cheryl Smith, MD; Frank McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD • Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhD • Shirley Irons; Kathlene Tracy, PhD

4. 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

5. STUDY RATIONALE • HIV/HCV/STI: major causes of excess morbidity and mortality in the US • Substance abuse: a major vehicle for the transmission of infection • Scope of, and challenges to identifying, counseling and treating persons with these infections in substance abuse treatment will assist in developing effective interventions

6. IMPORTANT ABREVIATIONS • AIDS = Acquired Immunodeficiency Syndrome • HIV = Human Immunodeficiency Virus • HCV = Hepatitis C Virus • STI = Sexually Transmitted Infections • CTP = Community Treatment Program • CTN = Clinical Trials Network • SOP = Standard Operating Procedures • IRB = Institutional (Human Subject) Review Board

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

8. PRIMARY OBJECTIVES • TO DESCRIBE: • Range of Infection-Related Services Available • CTP Characteristics (funding, staffing) • Perceived Barriers to Providing Infection-Related Services • State Regulatory Guidelines • TO EXAMINE ASSOCIATIONS BETWEEN: • CTPs’ Availability of Selected Infection Services • Other Constructs Listed Above

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

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

11. Administrator Surveys Contact CTP Directors for Treatment Program and Administrator contact information Administrator completes survey online or mails to Data Center; Administrator enters contact information for Clinicians 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

12. 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

13. STATISTICAL ELEMENTS • Sample Size and Precision of the Estimated Mean • Analytic Plan • Descriptive stats for survey variables • Principal Component or Cluster or Factor Analysis to group and reduce the number of variables • Structural Equation Models to test for associations

14. RESULTS • 269 out of 319 (84%) substance abuse program administrators responded administrators. • At least one health department or substance abuse agency administrator from 48 states and the District of Columbia (96%) responded

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

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

17. HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE TREATMENT PROGRAMS WHEN STATE MANDATED

18. RELATIONSHIP BETWEEN STATE MANDATES & PERCENT OF SUBSTANCE ABUSE TREATMENT PROGRAMS PROVIDING HIV/AIDS, HCV & STI-RELATED BEHAVIORAL SERVICES

19. HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE TREATMENT PROGRAMS WHEN NOT STATE MANDATED

20. RELATIONSHIP BETWEEN STATE MANDATES & PERCENT OF SUBSTANCE ABUSE TREATMENT PROGRAMS PROVIDING HIV/AIDS, HCV & STI-RELATED MEDICAL SERVICES

21. SUMMARY • Most HIV/AIDS, HCV & STI-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

22. SUMMARY • Six of eight targeted services were provided by a similar % of programs, regardless of state mandates • Two services (treatment and monitoring) were provided by a substantially higher percentage of sites where it was state mandated

23. SUMMARY • There is substantial variation in the % of programs offering the various services for a particular infection group • There is consistency in the % of programs offering a particular service for all three infection groups

24. ...And… THERE IS MORE DATA