2. Relationships Between the Availability of Infection-Related Services & Availability of Services Tailored for Subpopulations in Substance Abuse Treatment Programs: The NIDA Clinical Trials Network Lawrence S. Brown, Jr., MD, MPH, FASAM Addiction Research and Treatment Corporation Clinical Associate Professor of Public Health Weill Medical College, Cornell University Oral Presentation at the College on Problems of Drug Dependence Scottsdale, Arizona - June 18, 2006

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

4. 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: 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

5. GAME PLAN Rationale Rationale Main Study Description Main Study Description Disparities Secondary Analysis Disparities Secondary Analysis

6. BOTTOM LINE BOTTOM LINE Treatment programs of various descriptions offer an array of infection-related services; some do not. Treatment programs of various descriptions offer an array of infection-related services; some do not. Substance abuse treatment programs that offer services tailored for Women & Minorities were more likely to also offer infection-related services. Substance abuse treatment programs that offer services tailored for Women & Minorities were more likely to also offer infection-related services. A number of hypotheses & opportunities remain to be proposed, pursued, and answered A number of hypotheses & opportunities remain to be proposed, pursued, and answered These are preliminary results of a larger study These are preliminary results of a larger study

7. 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!

8. STUDY SITES 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

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

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

11. IMPORTANT DEFINITIONS IMPORTANT DEFINITIONS Treatment Program vs. NIDA CTN CTP Treatment Program vs. NIDA CTN CTP Services Assessed Services Assessed –Provider Education –Patient Education –Patient Risk Assessment –Patient Counseling –Patient Medical History & Physical Exam –Patient Biological Testing –Patient Treatment –Patient Monitoring Medical vs. Non-Medical Clinical Staff Medical vs. Non-Medical Clinical Staff ‘Expert’ Clinical Staff ‘Expert’ Clinical Staff

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

13. MAIN STUDY: PRIMARY OBJECTIVES TO DESCRIBE: TO DESCRIBE: –Range of Infection-Related Services Available –CTP Characteristics (funding, staffing) –Clinician Characteristics (training, knowledge, behavior) –Opinions –Perceived Barriers to Providing Infection-Related Services –State Regulatory Guidelines TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS BETWEEN: –CTPs ’ Availability of Selected Infection Services –Other Constructs Listed Above

14. MAIN STUDY: DESIGN AND POPULATION STUDY DESIGN STUDY DESIGN –3 Cross-sectional Surveys –Descriptive & Exploratory STUDY POPULATION STUDY POPULATION –CTP Administrators –CTP Clinicians –Administrators of State Health Departments and State Substance Abuse Agencies

15. 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

16. 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

17. 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

18. MEASUREMENTS & ANALYTICAL METHODS SAMPLING METHODOLOGY: At Each CTP … SAMPLING METHODOLOGY: At Each CTP … – All ‘Expert’ Clinicians Designated by the CTP – 10 randomly sampled ‘Non-Expert’ Clinicians, in a ratio of Medical:Non-Medical reflecting that of in a ratio of Medical:Non-Medical reflecting that of the CTP’s clinical staff the CTP’s clinical staff ANALYTIC METHODOLOGIES ANALYTIC METHODOLOGIES – ‘Experts’ will be analyzed separately – Clinicians may decline; next randomly selected person will be asked to participate selected person will be asked to participate

19. STATISTICAL ELEMENTS Sample Size and Precision of the Estimated Mean Sample Size and Precision of the Estimated Mean Analytic Plan 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

20. SURVEY RETURNS 269 administrators responded (84%) out of 319 substance abuse program administrators surveyed from 95 CTPs in the NIDA CTN, covering 26 states & DC 269 administrators responded (84%) out of 319 substance abuse program administrators surveyed from 95 CTPs in the NIDA CTN, covering 26 states & DC 1719 clinicians of 2207 targeted (78%) 1719 clinicians of 2207 targeted (78%) At least one substance abuse or health department administrator from 48 states and the District of Columbia (96%) At least one substance abuse or health department administrator from 48 states and the District of Columbia (96%)

21. Characteristics of Treatment Programs CharacteristicNumber of Surveys with Valid Responses Number (%) of Treatment Programs* Corporate structure Private not-for-profit Private for profit Government Other 268 212 (78.5) 15 (5.6) 36 (13.4) 6 (2.2) Largest source of revenue County/local grants State funds Medicaid Federal grants VA Benefits Medicare Private contracts/insurance Self-pay Other Unknown 269 45 (16.7) 103 (38.1) 46 (17.0) 33 (12.2) 5 (1.9) 4 (1.5) 9 (3.3) 15 (5.6) 3 (1.1) 7 (2.6) *Percentages do not total 100% due to rounding and non-respondents

22. Characteristics of Treatment Programs Patient census ≤500 500 – 1000 >1000 250 145 (53.9) 52 (19.3) 53 (19.7) Addiction Services Offered # Inpatient or residential services Outpatient pharmacotherapy Other outpatient services Outreach & support services 256 242 257 259 148 (55.0) 89 (33.1) 206 (76.6) 227 (84.4) Medical Staff 0 1 2-3 4-7 8+ 55 (20.4) 31 (11.5) 64 (23.8) 54 (20.1) 57 (21.2) Non-Medical Staff 0-7 8-11 12-17 18+ 79 (29.4) 59 (21.9) 64 (23.8) CharacteristicNumber of Surveys with Valid Responses Number (%) of Treatment Programs* *Percentages do not total 100% due to rounding and non-respondents # Responses were not mutually exclusive for this item

23. SECONDARY ANALYSIS LIMITED TO RESPONSES FROM ADMINISTRATOR SURVEYS LIMITED TO RESPONSES FROM ADMINISTRATOR SURVEYS TO REPORT THE AVAILABILITY OF SUBSTANCE ABUSE TREATMENT SERVICES SPECIFICALLY DESIGNED FOR: TO REPORT THE AVAILABILITY OF SUBSTANCE ABUSE TREATMENT SERVICES SPECIFICALLY DESIGNED FOR: –Women –Children –Teens –Minorities ( Black/African American, Hispanic/Latino, Indian/Eskimo, Asian, Hawaiian/Pacific Islanders)

24. SECONDARY ANALYSIS (CONT’D) TO REPORT THE AVAILABILITY OF SERVICES SPECIFICALLY DESIGNED WOMEN & MINORITIES IN TREATMENT PROGRAMS OFFERING INFECTION- RELATED SERVICES TO REPORT THE AVAILABILITY OF SERVICES SPECIFICALLY DESIGNED WOMEN & MINORITIES IN TREATMENT PROGRAMS OFFERING INFECTION- RELATED SERVICES TO REPORT THE AVAILABILITY OF INFECTION RELATED SERVICES IN TREATMENT PROGRAMS WITH SERVICES TAILORED FOR WOMEN & MINORITIES TO REPORT THE AVAILABILITY OF INFECTION RELATED SERVICES IN TREATMENT PROGRAMS WITH SERVICES TAILORED FOR WOMEN & MINORITIES

25. SUBSTANCE ABUSE TREATMENT PROGRAMS OFFERING SERVICES SPECIFICALLY FOR WOMEN AND MINORITIES: WomenChildrenTeens Minorities (all) n (%) 191 (71) 62 (23) 89 (33) 127 (47) Blacks Indian/ Eskimo HispanicAsian Hawaiian/ Pacific Isle n (%) 91 (34) 46 (17) 106 (39) 44 (16) 37 (14)

26. ARE SERVICES FOR POPULATIONS SUFFERING FROM DISPARATIES MORE PREVALENT IN TREATMENT PROGRAMS WITH INFECTION-RELATED SERVICES?

27. SERVICES TARGETED FOR SUBPOPULATIONS IN TREATMENT PROGRAMS WITH HIV/AIDS- RELATED SERVICES: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 130(73)74(44)86(50) Patient Education 164(75)82(39)95(45) Risk Assessment 161(74)79(38)92(44) Counseling132(76)74(45)80(48) History & Physical Examination 110(75)61(44)65(46) Biological Testing 95(74)50(42)55(45) Treatment79(79)54(56)57(58) Monitoring92(80)56(51)61(54)

28. SERVICES TARGETED FOR SUBPOPULATIONS IN TREATMENT PROGRAMS WITH HCV-RELATED SERVICES: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 122(73)62(40)74(47) Patient Education 149(76)73(39)82(44) Risk Assessment 148(77)71(39)82(45) Counseling121(77)66(45)70(47) History & Physical Examination 100(76)56(45)60(48) Biological Testing 67(74)43(50)43(50) Treatment58(76)44(59)42(58) Monitoring71(76)48(53)49(54)

29. SERVICES TARGETED FOR SUBPOPULATIONS IN TREATMENT PROGRAMS WITH STI-RELATED SERVICES: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 110(74)64(45)73(51) Patient Education 149(75)78(41)90(47) Risk Assessment 143(75)76(42)85(46) Counseling120(75)70(47)74(49) History & Physical Examination 98(75)57(47)61(50) Biological Testing 81(76)50(50)50(49) Treatment70(79)50(59)50(57) Monitoring79(77)54(54)57(56)

30. ARE INFECTION-RELATED MORE PREVALENT IN TREATMENT PROGRAMS OFFERING SERVICES FOR POPULATIONS SUFFERING FROM DISPARATIES ?

31. HIV/AIDS-RELATED SERVICES IN PROGRAMS WITH SERVICES TARGETED FOR SUBPOPULATIONS: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 130(73)74(86)86(85) Patient Education 164(92)82(95)95(94) Risk Assessment 161(90)79(92)92(91) Counseling132(75)74(86)80(82) History & Physical Examination 110(62)61(72)65(66) Biological Testing 95(54)50(60)55(57) Treatment79(45)54(64)57(58) Monitoring92(53)56(67)61(63)

32. HCV-RELATED SERVICES IN PROGRAMS WITH SERVICES TARGETED FOR SUBPOPULATIONS: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 122(68)62(72)74(73) Patient Education 149(82)73(84)82(81) Risk Assessment 148(81)71(82)82(81) Counseling121(66)66(76)70(70) History & Physical Examination 100(55)56(65)60(59) Biological Testing 67(37)43(49)43(43) Treatment58(32)44(51)42(42) Monitoring71(39)48(56)49(49)

33. STI-RELATED SERVICES IN PROGRAMS WITH SERVICES TARGETED FOR SUBPOPULATIONS: NIDA CTN Women Blacks Hispanics Service n (%) Provider Education 110(61)64(74)73(72) Patient Education 149(82)78(89)90(87) Risk Assessment 143(79)76(86)85(83) Counseling120(66)70(81)74(73) History & Physical Examination 98(54)57(65)61(59) Biological Testing 81(44)50(56)50(48) Treatment70(38)50(57)50(49) Monitoring79(44)54(63)57(55)

34. LIMITATIONS Innate drawbacks of secondary analysis Innate drawbacks of secondary analysis Lack of detailed description of services tailored for women and minorities Lack of detailed description of services tailored for women and minorities No date on utilization, cost, efficiency, or effectiveness of subpopulation-tailored services or infection-related services. No date on utilization, cost, efficiency, or effectiveness of subpopulation-tailored services or infection-related services.

35. SUMMARY Substance Abuse Treatment Services Tailored for Women were Available in: Substance Abuse Treatment Services Tailored for Women were Available in: –75% or more in substance abuse treatment programs offering any infection-related service. Substance Abuse Treatment Services Tailored for African Americans and Hispanics were Available in: Substance Abuse Treatment Services Tailored for African Americans and Hispanics were Available in: –more than 50% of substance abuse treatment programs offering treatment or monitoring infection-related services

36. SUMMARY Of Treatment Programs with services tailored for women and minorities Of Treatment Programs with services tailored for women and minorities –Infection-related services more prevalent in programs with services tailored for AA & Hispanics than women –Non-medical infection services more prevalent than medical infection services –HIV-related services more prevalent than HCV or STI-related services

37. NEXT STEPS Tests for significance Tests for significance Generate additional hypotheses for testing Generate additional hypotheses for testing

38. FOR MORE INFORMATION ABOUT THIS STUDY FOR MORE INFORMATION ABOUT THIS STUDY PEER-REVIEWED PUBLICATIONS PEER-REVIEWED PUBLICATIONS –Brown LS. et. al., Journal of Substance Abuse Treatment, 2006;30: 315-321 CONTACTING STUDY PERSONNEL CONTACTING STUDY PERSONNEL –Dr. Brown, the Lead Investigator: lbrown@artcny.org –Steven Kritz, MD – the Project Director: skritz@artcny.org