2. Characteristics of Screening, Evaluation, and Treatment of HIV/AIDS, Hepatitis C Viral Infections, and Sexually Transmitted Infections in Substance Abuse Treatment Programs (NIDA CTN-0012) L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; Edmund Bini, MD, MPH; J. Robinson, MEd; S. Baker, PhD, and the NIDA Clinical Trials Network Infections Study (CTN-0012) Team Poster Presentations at the American Public Health Association, Philadelphia, PA and American College of Neuropsychopharmacology, Kona, Hawaii, December, 2005

3. ABSTRACT ABSTRACT Introduction: In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C, and sexually transmitted infections. Substance abuse treatment programs can play a major role in stemming these epidemics. A nationwide CTN study, sponsored by NIDA, examines these three infection groups from the perspective of administrators and clinicians working in substance abuse treatment programs. The NIDA CTN has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across the US. Methods: Three surveys were developed; one each for substance abuse treatment program administrators and clinicians, and one for state health and substance abuse department administrators. These surveys looked at service availability, government mandates, funding, and other key elements involved in evaluating and caring for patients in each of the three infection groups. Results: Completed surveys were obtained from 269 administrators and 1723 clinicians working at substance abuse treatment sites. At the state level, completed surveys were returned by administrators from 48 states and the District of Columbia. Preliminary data is presented.This study will allow for examination of associations between the activities at substance abuse treatment programs and the states within which they are located in dealing with the three infection groups. This data and other information can then be used to encourage “best practices” in treating these epidemic infections. Introduction: In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C, and sexually transmitted infections. Substance abuse treatment programs can play a major role in stemming these epidemics. A nationwide CTN study, sponsored by NIDA, examines these three infection groups from the perspective of administrators and clinicians working in substance abuse treatment programs. The NIDA CTN has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across the US. Methods: Three surveys were developed; one each for substance abuse treatment program administrators and clinicians, and one for state health and substance abuse department administrators. These surveys looked at service availability, government mandates, funding, and other key elements involved in evaluating and caring for patients in each of the three infection groups. Results: Completed surveys were obtained from 269 administrators and 1723 clinicians working at substance abuse treatment sites. At the state level, completed surveys were returned by administrators from 48 states and the District of Columbia. Preliminary data is presented. Summary: This study will allow for examination of associations between the activities at substance abuse treatment programs and the states within which they are located in dealing with the three infection groups. This data and other information can then be used to encourage “best practices” in treating these epidemic infections.

4. 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 –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 AIDS = Acquired Immunodeficiency Syndrome AIDS = Acquired Immunodeficiency Syndrome HIV = Human Immunodeficiency Virus HIV = Human Immunodeficiency Virus 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 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

10. 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, and Other Constructs Listed Above

11. 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

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. Clinician Surveys Statistician selects Clinicians from Treatment Programs based on contact information provided by Administrators Clinician surveys mailed Gathering sessions held for Clinicians to complete surveys Clinician completes survey online or mails to Data Center Completed surveys mailed to Data Center Data Center contacts non- responders after 30 days; flagged as non-responders after four weekly failed attempts If non-responder is a randomly selected Clinician, the next eligible Clinician on the selection list is sent a survey Data Center monitors the data entry of Clinicians Data Center contacts Clinicians to resolve any data queries Randomization

16. 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

17. 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

18. 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

19. 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 1723 clinicians of 2210 targeted (78%) 1723 clinicians of 2210 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%).

20. 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

21. 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

22. HIV/AIDS, HCV & STI-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269) HIV/AIDSHCVSTIs n (%) Risk Assessment 224 (89) 194 (77) 195 (77) Patient Education 226 (84) 200 (74) 205 (76) Patient Counseling 178 (66) 159 (59) 163 (60) History & Physical Examination 150 (56) 135 (50) 133 (49) Biological Assessments 131 (49) 93 (34) 109 (40) Pharmacotherapies Administered/ Prescribed 103 (38) 78 (29) 92 (34) Clinical Monitoring 117 (43) 95 (35) 105 (39)

23. PRELIMINARY RESULTS: TREATMENT PROGRAM CHARACTERISTICS BY HIV/AIDS, HCV & STI-RELATED SERVICES: For- Profit Non- Profit Residential Drug Free Methadone n (%) HIV Provider Education 15 (93) 146 (75) 59 (82) 105 (74) 61 (82) HCV Patient Counseling 13 (87) 114 (57) 48 (66) 92 (63) 65 (87) STI Patient Counseling 13 (87) 123 (62) 54 (73) 92 (63) 61 (82) STI Biological Assessments 12 (80) 76 (38) 33 (45) 51 (35) 56 (74)

24. PRELIMINARY RESULTS: Relationship Between Treatment Program (TP) Ownership & Service Provision TP Ownership TP Ownership –78% Not For Profit –6% For Profit TP Administrator Respondents TP Administrator Respondents –In States With Guidelines/Regulations/Policies: 77% Provide the Service –In States Without Guidelines/Regulations/Policies: 65% Provide the Service

25. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) Provision of HIV Provider Education State Administrator Respondents State Administrator Respondents –67% Reported Guidelines/Regulations/Policies TP Administrator Respondents TP Administrator Respondents –In States With Guidelines/Regulations/Policies: 77% Provide the Service –In States Without Guidelines/Regulations/Policies: 65% Provide the Service

26. PRELIMINARY RESULTS: Relationship Between State Policy & TP HCV Patient Risk Assessment State Administrator Respondents State Administrator Respondents –53% Reported Guidelines/Regulations/Policies TP Administrator Respondents 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

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

28. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) STI Patient Counseling State Administrator Respondents State Administrator Respondents –41% Reported Guidelines/Regulations/Policies TP Administrator Respondents TP Administrator Respondents –In States With Guidelines/Regulations/Policies: 70% of Programs Provide the Service –In States Without Guidelines/Regulations/Policies: 76% of Programs Provide the Service

29. 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.

30. SUMMARY Staffing patterns (medical and non- medical) are quite varied. Staffing patterns (medical and non- medical) are quite varied. There is… There is… –substantial variation in the % of programs offering the various services for a particular infection group, –consistency in the % of programs offering a particular service for all three infection groups.

31. SUMMARY Significant opportunities exist to explore associations between the HIV/AIDS, HCV & STI- related services offered and Significant opportunities exist to explore associations between the HIV/AIDS, HCV & STI- 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 –State Regulatory Guidelines