2. Relationships between State Policies and the Availability of Services for HIV/AIDS, Hepatitis C Viral Infection, and Sexually Transmitted Infections in Substance Abuse Treatment Programs L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. Robinson, MEd and the NIDA Clinical Trials Network Infections Study (CTN-0012) Team Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, Cincinnati, OH; and Nathan Kline Institute, Orangeburg, NY

3. ABSTRACT ABSTRACT Purpose: This report examines the associations between HIV/AIDS, hepatitis C (HCV), and sexually transmitted infection (STI)-related services provided by substance abuse treatment programs in the National Institute on Drug Abuse Clinical Trials Network (NIDA CTN), and the states within which they are located. Methods: Substance abuse treatment programs from nearly 100 different agencies within the NIDA CTN participated in this study. Administrators of state substance abuse and/or health departments from 48 states and the District of Columbia also participated. Data for this report was derived from two surveys: one for substance abuse treatment program administrators, and one for state health and substance abuse department administrators. The surveys included a cross-sectional, descriptive survey of eight infection- related services: provider education, patient education, risk assessment, history and physical exam, biological testing, counseling, treatment and monitoring in the context of treatment program structure, setting, and staffing. The analysis included descriptive statistics for survey variables; principal component, cluster or factor analysis to group and reduce the number of variables, and structural equation models to test for associations. Results: 265 of 313 (86%) substance abuse treatment program administrators responded from 95 agencies in the NIDA CTN, covering 26 states & DC. Six of eight services were provided by a similar percentage of substance abuse programs regardless of state mandates, whereas two services (treatment and monitoring) were provided by a substantially higher percentage of sites where it was state mandated.Summary: There was variation in the % of programs offering the various services for a particular infection group, whether state mandated or not, however; there was consistency in the % of programs offering a particular service for all three infection groups, whether state mandated or not. This information can be used to inform public policy to encourage “best practices” in treating these epidemic infections. Purpose: This report examines the associations between HIV/AIDS, hepatitis C (HCV), and sexually transmitted infection (STI)-related services provided by substance abuse treatment programs in the National Institute on Drug Abuse Clinical Trials Network (NIDA CTN), and the states within which they are located. Methods: Substance abuse treatment programs from nearly 100 different agencies within the NIDA CTN participated in this study. Administrators of state substance abuse and/or health departments from 48 states and the District of Columbia also participated. Data for this report was derived from two surveys: one for substance abuse treatment program administrators, and one for state health and substance abuse department administrators. The surveys included a cross-sectional, descriptive survey of eight infection- related services: provider education, patient education, risk assessment, history and physical exam, biological testing, counseling, treatment and monitoring in the context of treatment program structure, setting, and staffing. The analysis included descriptive statistics for survey variables; principal component, cluster or factor analysis to group and reduce the number of variables, and structural equation models to test for associations. Results: 265 of 313 (86%) substance abuse treatment program administrators responded from 95 agencies in the NIDA CTN, covering 26 states & DC. Six of eight services were provided by a similar percentage of substance abuse programs regardless of state mandates, whereas two services (treatment and monitoring) were provided by a substantially higher percentage of sites where it was state mandated. Summary: There was variation in the % of programs offering the various services for a particular infection group, whether state mandated or not, however; there was consistency in the % of programs offering a particular service for all three infection groups, whether state mandated or not. This information can be used to inform public policy to encourage “best practices” in treating these epidemic infections.

4. ACKNOWLEDGEMENTS 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: 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

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 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 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

8. 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

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

10. PRIMARY OBJECTIVES TO DESCRIBE: 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: TO EXAMINE ASSOCIATIONS BETWEEN: –CTPs ’ Availability of Selected Infection Services –Other Constructs Listed Above

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

12. 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

13. 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

14. 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

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

16. 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

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 269 administrators responded (84%) out of 319 substance abuse program administrators surveyed, from 95 CTPs in the NIDA CTN, covering 26 states & DC At least one health department or substance abuse agency administrator from 48 states and the District of Columbia (96%) responded At least one health department or substance abuse agency administrator from 48 states and the District of Columbia (96%) responded

18. 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

19. 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

20. HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE TREATMENT PROGRAMS WHEN STATE MANDATED HIV/AIDSHCVSTIs n (%) Provider Education 137 (77) 113 (69) 113 (64) Patient Education 218 (90) 140 (80) 154 (84) Risk Assessment 180 (91) 147 (79) 140 (82) History & Physical Examination 67 (59) 62 (57) 58 (54) Biological Testing 65 (52) 48 (43) 53 (47) Counseling 137 (72) 93 (73) 75 (70) Treatment 66 (59) 38 (56) 42 (51) Monitoring 44 (72) 38 (69) 43 (70)

21. HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE TREATMENT PROGRAMS WHEN NOT STATE MANDATED HIV/AIDSHCVSTIs n (%) Provider Education 48 (65) 57 (65) 41 (54) Patient Education 7 (88) 58 (75) 49 (70) Risk Assessment 42 (79) 45 (65) 53 (65) History & Physical Examination 60 (59) 54 (50) 57 (51) Biological Testing 66 (54) 45 (32) 56 (39) Counseling 39 (71) 65 (52) 87 (59) Treatment 37 (27) 40 (25) 50 (29) Monitoring 72 (39) 57 (29) 62 (32)

22. SUMMARY Most HIV/AIDS, HCV & STI-related services are offered by: 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 Staffing patterns (medical and non- medical) are quite varied

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

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

25. ...And… THERE IS MORE DATA