The NIDA Clinical Trials Network Infections Study (CTN-0012)
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Transcript of The NIDA Clinical Trials Network Infections Study (CTN-0012)
STATE POLICIES & STATE POLICIES & AVAILABILITY OF INFECTION-AVAILABILITY OF INFECTION-
RELATED SERVICES IN RELATED SERVICES IN SUSTANCE ABUSE SUSTANCE ABUSE
TREATMENT PROGRAMS – TREATMENT PROGRAMS –
CONNECTED AT THE HIP?CONNECTED AT THE HIP?
The NIDA Clinical Trials The NIDA Clinical Trials Network Infections Study Network Infections Study (CTN-0012)(CTN-0012)
Lawrence S. Brown, Jr., MD, MPH, Lawrence S. Brown, Jr., MD, MPH, FASAM; Steven Kritz, MD; John FASAM; Steven Kritz, MD; John Rotrosen, MD; Jeff Goldsmith, MD; Rotrosen, MD; Jeff Goldsmith, MD; Edmund Bini, MD, MPH; Jim Robinson, Edmund Bini, MD, MPH; Jim Robinson, MEdMEd
Addiction Research & Treatment Corp, Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; University of and VA Hospital, NY, NY; University of Cincinnati Medical Center, Cincinnati, Cincinnati Medical Center, Cincinnati, OH; Nathan Kline Institute, OH; Nathan Kline Institute,
Orangeburg, NYOrangeburg, NY
ACKNOWLEDGEMENTSACKNOWLEDGEMENTS
• Research Supported by National Institute Research Supported by National Institute on Drug Abuse (NIDA) as part of a on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046)Cooperative Agreement (1U10DA013046) with the NIDA CTN and other Protocol Team with the NIDA CTN and other Protocol Team members consisting of:members consisting of:– Randy Seewald, MD; Cheryl Smith, MD; Frank Randy Seewald, MD; Cheryl Smith, MD; Frank
McCorry, PhD; Dennis McCarty, PhD; Donald McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD Kipnis, MD
– Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhDKaren Reese, CAC-AD; Sherryl Baker, PhD
– Shirley Irons; Shirley Irons; Kathlene Tracy, PhDKathlene Tracy, PhD
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 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States!Agencies Reaching into 26 States!
STUDY RATIONALESTUDY RATIONALE
• HIV/HCV/STI: major causes of excess HIV/HCV/STI: major causes of excess morbidity and mortality in the USmorbidity and mortality in the US
• Substance abuse: a major vehicle for Substance abuse: a major vehicle for the transmission of infectionthe transmission of infection
• Scope of, and challenges to Scope of, and challenges to identifying, counseling and treating identifying, counseling and treating persons with these infections in persons with these infections in substance abuse treatment will assist substance abuse treatment will assist in developing effective interventionsin developing effective interventions
IMPORTANT IMPORTANT ABREVIATIONSABREVIATIONS• AIDS = Acquired Immunodeficiency SyndromeAIDS = Acquired Immunodeficiency Syndrome
• HIV = Human Immunodeficiency VirusHIV = Human Immunodeficiency Virus
• HCV = Hepatitis C VirusHCV = Hepatitis C Virus
• STI = Sexually Transmitted InfectionsSTI = Sexually Transmitted Infections
• CTP = Community Treatment ProgramCTP = Community Treatment Program
• CTN = Clinical Trials NetworkCTN = Clinical Trials Network
• SOP = Standard Operating ProceduresSOP = Standard Operating Procedures
• IRB = Institutional (Human Subject) Review IRB = Institutional (Human Subject) Review BoardBoard
IMPORTANT TERMSIMPORTANT TERMS
• Treatment Program vs. NIDA CTN CTPTreatment Program vs. NIDA CTN CTP
• Services AssessedServices Assessed– Provider EducationProvider Education
– Patient EducationPatient Education
– Patient Risk AssessmentPatient Risk Assessment
– Patient Medical History & Physical ExamPatient Medical History & Physical Exam
– Patient Biological TestingPatient Biological Testing
– Patient CounselingPatient Counseling
– Patient TreatmentPatient Treatment
– Patient MonitoringPatient Monitoring
PRIMARY OBJECTIVESPRIMARY OBJECTIVES
• TO DESCRIBE:TO DESCRIBE: – Range of Infection-Related Services AvailableRange of Infection-Related Services Available– CTP Characteristics (funding, staffing)CTP Characteristics (funding, staffing)– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-
Related ServicesRelated Services– State Regulatory GuidelinesState Regulatory Guidelines
• TO EXAMINE ASSOCIATIONS TO EXAMINE ASSOCIATIONS BETWEEN: BETWEEN: – CTPs’ Availability of Selected Infection ServicesCTPs’ Availability of Selected Infection Services– Other Constructs Listed AboveOther Constructs Listed Above
DESIGN AND POPULATIONDESIGN AND POPULATION
• STUDY DESIGNSTUDY DESIGN– 2 2 Cross-sectional Surveys Cross-sectional Surveys – Descriptive & ExploratoryDescriptive & Exploratory
• STUDY POPULATIONSTUDY POPULATION– CTP AdministratorsCTP Administrators– Administrators of State Health Administrators of State Health
Departments and Substance Abuse Departments and Substance Abuse AgenciesAgencies
ETHICAL, REGULATORY ETHICAL, REGULATORY AND ADMINISTRATIVE AND ADMINISTRATIVE
CONSIDERATIONSCONSIDERATIONS
• Expedited IRB Approval Expedited IRB Approval
• Waiver of Informed ConsentWaiver of Informed Consent
• Training for Node Protocol Training for Node Protocol ManagersManagers
Administrator SurveysContact CTP Directors for Treatment Program and Administrator contact information
Survey materials mailed to Administrators
Ensure IRBapproval
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 Administratorsthat have not completed the survey or Clinician contact information within 30 days
Data Center contactsAdministratorsto resolve any data queries
After four weekly attempts, Administrators flagged as non-responders by the Data Center
Node Protocol Managers contact non-responderAdministrators 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
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 Administratorsthat have not completed surveywithin 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
STATISTICAL STATISTICAL ELEMENTSELEMENTS
• Sample Size and Precision of the Sample Size and Precision of the Estimated MeanEstimated Mean
• Analytic PlanAnalytic Plan– Descriptive stats for survey variablesDescriptive stats for survey variables– Principal Component or Cluster or Factor Principal Component or Cluster or Factor
Analysis to group and reduce the Analysis to group and reduce the number of variablesnumber of variables
– Structural Equation Models to test for Structural Equation Models to test for associationsassociations
RESULTSRESULTS
• 269 out of 319 269 out of 319 (84%)(84%) substance substance abuse program administrators abuse program administrators responded administrators.responded administrators.
• At least one health department or At least one health department or substance abuse agency substance abuse agency administrator from 48 states and the administrator from 48 states and the District of Columbia District of Columbia (96%) (96%) responded responded
Characteristics of Treatment Programs Characteristic Number of Surveys with
Valid ResponsesNumber (%) of
Treatment Programs*
Corporate structure Private not-for-profit Private for profit Government Other
268212 (78.5)15 (5.6)
36 (13.4)6 (2.2)
Largest source of revenueCounty/local grants State funds Medicaid Federal grants VA Benefits Medicare Private contracts/insurance Self-pay Other Unknown
26945 (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-respondentsPercentages do not total 100% due to rounding and non-respondents
Characteristics of Treatment Programs
Patient census ≤500 500 – 1000 >1000
250145 (53.9)52 (19.3)53 (19.7)
Addiction Services Offered # Inpatient or residential services Outpatient pharmacotherapy Other outpatient services Outreach & support services
256242257259
148 (55.0)89 (33.1)
206 (76.6)227 (84.4)
Medical Staff 01
2-34-78+
55 (20.4)31 (11.5)64 (23.8)54 (20.1)57 (21.2)
Non-Medical Staff 0-78-11
12-1718+
79 (29.4)59 (21.9)59 (21.9)64 (23.8)
Characteristic Number of Surveys with Valid Responses
Number (%) of Treatment Programs*
**Percentages do not total 100% due to rounding and non-respondentsPercentages do not total 100% due to rounding and non-respondents## Responses were not mutually exclusive for this item Responses were not mutually exclusive for this item
HIV/AIDS, HCV & STI-RELATED SERVICES HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE PROVIDED IN SUBSTANCE ABUSE
TREATMENT PROGRAMS WHEN STATE TREATMENT PROGRAMS WHEN STATE MANDATEDMANDATED
HIV/AIDSHIV/AIDS HCVHCV STIsSTIs
n (%)n (%) n (%)n (%) n (%)n (%)Provider EducationProvider Education 137 (77)137 (77) 113 (69)113 (69) 113 (64)113 (64)
Patient EducationPatient Education 218 (90)218 (90) 140 (80)140 (80) 154 (84)154 (84)
Risk AssessmentRisk Assessment 180 (91)180 (91) 147 (79)147 (79) 140 (82)140 (82)
History & Physical History & Physical ExaminationExamination
67 (59)67 (59) 62 (57)62 (57) 58 (54)58 (54)
Biological TestingBiological Testing 65 (52)65 (52) 48 (43)48 (43) 53 (47)53 (47)
CounselingCounseling 137 (72)137 (72) 93 (73)93 (73) 75 (70)75 (70)
TreatmentTreatment 66 (59)66 (59) 38 (56)38 (56) 42 (51)42 (51)
MonitoringMonitoring 44 (72)44 (72) 38 (69)38 (69) 43 (70)43 (70)
RELATIONSHIP BETWEEN STATE MANDATES RELATIONSHIP BETWEEN STATE MANDATES & PERCENT OF SUBSTANCE ABUSE & PERCENT OF SUBSTANCE ABUSE
TREATMENT PROGRAMS PROVIDING TREATMENT PROGRAMS PROVIDING HIV/AIDS, HCV & STI-RELATED BEHAVIORAL HIV/AIDS, HCV & STI-RELATED BEHAVIORAL
SERVICESSERVICES
INFECTIONINFECTION STATESTATE
MANDATEMANDATEDD
PATIENTPATIENT
EDUCATIOEDUCATIONN
RISKRISK
ASSESSMENASSESSMENTT
COUNSELINCOUNSELINGG
HIV/AIDSHIV/AIDS YESYES 90%90% 91%91% 72%72%
NONO 88%88% 79%79% 71%71%
HCVHCV YESYES 80%80% 79%79% 73%73%
NONO 75%75% 65%65% 52%52%
STIsSTIs YESYES 84%84% 82%82% 70%70%
NONO 70%70% 65%65% 59%59%
HIV/AIDS, HCV & STI-RELATED SERVICES HIV/AIDS, HCV & STI-RELATED SERVICES PROVIDED IN SUBSTANCE ABUSE PROVIDED IN SUBSTANCE ABUSE
TREATMENT PROGRAMS WHEN NOT STATE TREATMENT PROGRAMS WHEN NOT STATE MANDATED MANDATED
HIV/AIDSHIV/AIDS HCVHCV STIsSTIs
n (%)n (%) n (%)n (%) n (%)n (%)Provider EducationProvider Education 48 (65)48 (65) 57 (65)57 (65) 41 (54)41 (54)
Patient EducationPatient Education 7 (88)7 (88) 58 (75)58 (75) 49 (70)49 (70)
Risk AssessmentRisk Assessment 42 (79)42 (79) 45 (65)45 (65) 53 (65)53 (65)
History & Physical History & Physical ExaminationExamination
60 (59)60 (59) 54 (50)54 (50) 57 (51)57 (51)
Biological TestingBiological Testing 66 (54)66 (54) 45 (32)45 (32) 56 (39)56 (39)
CounselingCounseling 39 (71)39 (71) 65 (52)65 (52) 87 (59)87 (59)
TreatmentTreatment 37 (27)37 (27) 40 (25)40 (25) 50 (29)50 (29)
MonitoringMonitoring 72 (39)72 (39) 57 (29)57 (29) 62 (32)62 (32)
RELATIONSHIP BETWEEN STATE RELATIONSHIP BETWEEN STATE MANDATES & PERCENT OF SUBSTANCE MANDATES & PERCENT OF SUBSTANCE
ABUSE TREATMENT PROGRAMS ABUSE TREATMENT PROGRAMS PROVIDING HIV/AIDS, HCV & STI-PROVIDING HIV/AIDS, HCV & STI-
RELATED MEDICAL SERVICESRELATED MEDICAL SERVICES
INFECTIONINFECTION STATESTATE
MANDATEMANDATEDD
HISTORY & HISTORY & PHYS PHYS EXAMEXAM
TREATMENTTREATMENT MONITORINMONITORINGG
HIV/AIDSHIV/AIDS YESYES 59%59% 59%59% 72%72%
NONO 59%59% 27%27% 39%39%
HCVHCV YESYES 57%57% 56%56% 69%69%
NONO 50%50% 25%25% 29%29%
STIsSTIs YESYES 54%54% 51%51% 70%70%
NONO 51%51% 29%29% 32%32%
SUMMARYSUMMARY• Most HIV/AIDS, HCV & STI-related Most HIV/AIDS, HCV & STI-related
services are offered by:services are offered by:– a substantial proportion of private not-a substantial proportion of private not-
for-profit, for-profit, and public agenciesfor-profit, for-profit, and public agencies– a substantial proportion of substance a substantial proportion of substance
abuse treatment programs of all sizesabuse treatment programs of all sizes
• Staffing patterns (medical and non-Staffing patterns (medical and non-medical) are quite variedmedical) are quite varied
SUMMARYSUMMARY• Six of eight targeted services were Six of eight targeted services were
provided by a similar % of programs, provided by a similar % of programs, regardless of state mandatesregardless of state mandates
• Two services (treatment and Two services (treatment and monitoring) were provided by a monitoring) were provided by a substantially higher percentage of substantially higher percentage of sites where it was state mandatedsites where it was state mandated
SUMMARYSUMMARY• There is substantial variation in the There is substantial variation in the
% of programs offering the various % of programs offering the various services for a particular infection services for a particular infection groupgroup
• There is consistency in the % of There is consistency in the % of programs offering a particular programs offering a particular service for all three infection groupsservice for all three infection groups