Characteristics of Screening, Characteristics of Screening, Evaluation, and Treatment of Evaluation, and Treatment of
HIV/AIDS, HIV/AIDS, Hepatitis C Viral Infections, and Hepatitis C Viral Infections, and
Sexually Sexually Transmitted Infections in Substance Transmitted Infections in Substance
Abuse Abuse Treatment Programs (NIDA CTN-0012)Treatment Programs (NIDA CTN-0012)
L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; Edmund Bini, MD, MD; R.J. Goldsmith, MD; Edmund Bini, MD, MPH; J. Robinson, MEd; S. Baker, PhD, and the MPH; J. Robinson, MEd; S. Baker, PhD, and the NIDA Clinical Trials Network Infections Study NIDA Clinical Trials Network Infections Study (CTN-0012) Team(CTN-0012) Team
Addiction Research & Treatment Corp, Brooklyn, Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, NY; University of Cincinnati Medical Center, Cincinnati, OH; and Nathan Kline Institute, Cincinnati, OH; and Nathan Kline Institute, Orangeburg, NYOrangeburg, NY
ABSTRACTABSTRACTIntroduction: Introduction: In the US, users of illicit drugs will largely sustain the epidemics of In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C, and sexually transmitted infections. Substance abuse HIV/AIDS, hepatitis C, and sexually transmitted infections. Substance abuse treatment programs can play a major role in stemming these epidemics. A treatment programs can play a major role in stemming these epidemics. A nationwide CTN study, sponsored by NIDA, examines these three infection groups nationwide CTN study, sponsored by NIDA, examines these three infection groups from the perspective of administrators and clinicians working in substance abuse from the perspective of administrators and clinicians working in substance abuse treatment programs. The NIDA CTN has over 100 Community Treatment Programs treatment programs. The NIDA CTN has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across the US. the US. Methods: Methods: Three surveys were developed; one each for substance abuse Three surveys were developed; one each for substance abuse treatment program administrators and clinicians, and one for state health and treatment program administrators and clinicians, and one for state health and substance abuse department administrators. These surveys looked at service substance abuse department administrators. These surveys looked at service availability, government mandates, funding, and other key elements involved in availability, government mandates, funding, and other key elements involved in evaluating and caring for patients in each of the three infection groups. evaluating and caring for patients in each of the three infection groups. Results: Results: Completed surveys were obtained from 269 administrators and 1723 clinicians Completed surveys were obtained from 269 administrators and 1723 clinicians working at substance abuse treatment sites. At the state level, completed surveys working at substance abuse treatment sites. At the state level, completed surveys were returned by administrators from 48 states and the District of Columbia. were returned by administrators from 48 states and the District of Columbia. Preliminary data is presented.Preliminary data is presented. Summary: This study will allow for examination of This study will allow for examination of associations between the activities at substance abuse treatment programs and the 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 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 data and other information can then be used to encourage “best practices” in treating these epidemic infections.treating these epidemic infections.
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-ADKaren Reese, CAC-AD
– Shirley Irons; Shirley Irons; Kathlene Tracy, PhD Kathlene 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 SITESSTUDY SITES• New York Node:New York Node: New York University, New York, NYNew York University, New York, NY• South Carolina Node:South Carolina Node: Medical University of South Carolina, Medical University of South Carolina,
Charleston, SCCharleston, SC• Florida Node:Florida Node: University of Miami, Coral Gables, FLUniversity of Miami, Coral Gables, FL• Great Lakes Node:Great Lakes Node: Wayne State University, Detroit, MIWayne State University, Detroit, MI• Ohio Valley Node:Ohio Valley Node: University of Cincinnati, Cincinnati, OHUniversity of Cincinnati, Cincinnati, OH• Rocky Mountain Node:Rocky Mountain Node: University of CO Health Sciences Center, University of CO Health Sciences Center,
Denver, CODenver, CO• New England Node:New England Node: Yale University, New Haven, CTYale University, New Haven, CT• Delaware Valley Node:Delaware Valley Node: University of Pennsylvania, Philadelphia, PAUniversity of Pennsylvania, Philadelphia, PA• Mid-Atlantic Node:Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical Johns Hopkins Univ., Baltimore, MD; Medical
College College of Virginia, Richmondof Virginia, Richmond• Pacific Region Node:Pacific Region Node: University of California at Los Angeles, CAUniversity of California at Los Angeles, CA• Oregon Node:Oregon Node: Oregon Health Sciences University, Portland, OROregon Health Sciences University, Portland, OR• Washington Node:Washington Node: University of Washington, Seattle, WAUniversity of Washington, Seattle, WA• Long Island Node:Long Island Node: NY State Psychiatric Institute, New York, NYNY State Psychiatric Institute, New York, NY• North Carolina Node:North Carolina Node: Duke University, Raleigh/Durham, NCDuke University, Raleigh/Durham, NC• Southwest Node:Southwest Node: University of New Mexico, Albuquerque, NMUniversity of New Mexico, Albuquerque, NM• Northern New England Node:Northern New England Node: McLean Hospital, Belmont, MAMcLean Hospital, Belmont, MA• California-Arizona Node:California-Arizona Node: University of California at San Francisco, CAUniversity of California at San Francisco, CA
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 IMPORTANT DEFINITIONSDEFINITIONS• 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 CounselingPatient Counseling
– Patient Medical History & Physical ExamPatient Medical History & Physical Exam
– Patient Biological TestingPatient Biological Testing
– Patient TreatmentPatient Treatment
– Patient MonitoringPatient Monitoring
• Medical vs. Non-Medical Clinical StaffMedical vs. Non-Medical Clinical Staff
• ‘‘Expert’ Clinical StaffExpert’ Clinical Staff
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)– Clinician Characteristics (training, knowledge, Clinician Characteristics (training, knowledge,
behavior)behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Related Perceived Barriers to Providing Infection-Related
ServicesServices– State Regulatory GuidelinesState Regulatory Guidelines
• TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS BETWEEN: CTPs’ Availability of Selected Infection Services, andCTPs’ Availability of Selected Infection Services, and
Other Constructs Listed AboveOther Constructs Listed Above
DESIGN AND POPULATIONDESIGN AND POPULATION
• STUDY DESIGNSTUDY DESIGN– 3 3 Cross-sectional Surveys Cross-sectional Surveys – Descriptive & ExploratoryDescriptive & Exploratory
• STUDY POPULATIONSTUDY POPULATION– CTP AdministratorsCTP Administrators– CTP CliniciansCTP Clinicians– Administrators of State Health Administrators of State Health
Departments and State Substance Abuse Departments and State Substance Abuse AgenciesAgencies
ETHICAL, REGULATORY ETHICAL, REGULATORY & ADMINISTRATIVE & ADMINISTRATIVE CONSIDERATIONSCONSIDERATIONS
• Expedited IRB Approval Expedited IRB Approval
• Waiver of Informed ConsentWaiver of Informed Consent
• Training for Node Protocol Training for Node Protocol ManagersManagers
STUDY STUDY PROCEDURESPROCEDURES
• Node Protocol Managers Node Protocol Managers
• Information Sheet In Lieu of Informed Information Sheet In Lieu of Informed ConsentConsent
• Survey AdministrationSurvey Administration– Paper or ElectronicPaper or Electronic– Central data acquisitionCentral data acquisition
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
Clinician SurveysStatistician selects Clinicians from Treatment Programs based on contact information provided by Administrators
Clinician surveys mailed
Gathering sessions held for Clinicians to complete surveys
Clinician completessurvey online or mails to Data Center
Completed surveys mailed to Data CenterData Center
contacts non-responders after 30 days; flagged as non-responders after four weekly failed attempts
If non-responder isa 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
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
MEASUREMENTS & MEASUREMENTS & ANALYTICAL METHODSANALYTICAL METHODS
• SAMPLING METHODOLOGY:SAMPLING METHODOLOGY:At Each CTP …At Each CTP …– All ‘Expert’ Clinicians Designated by the CTPAll ‘Expert’ Clinicians Designated by the CTP– 10 randomly sampled ‘Non-Expert’ Clinicians, 10 randomly sampled ‘Non-Expert’ Clinicians,
in a ratio of Medical:Non-Medical reflecting that in a ratio of Medical:Non-Medical reflecting that of of
the CTP’s clinical staffthe CTP’s clinical staff
• ANALYTIC METHODOLOGIESANALYTIC METHODOLOGIES– ‘‘Experts’ will be analyzed separatelyExperts’ will be analyzed separately– Clinicians may decline; next randomly Clinicians may decline; next randomly
selected person will be asked to participateselected person will be asked to participate
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 administrators responded 269 administrators responded (84%)(84%) out out of 319 substance abuse program of 319 substance abuse program administrators surveyed, from 95 CTPs in administrators surveyed, from 95 CTPs in the NIDA CTN, covering 26 states & DCthe NIDA CTN, covering 26 states & DC
• 1723 clinicians of 2210 targeted 1723 clinicians of 2210 targeted (78%)(78%)
• At least one substance abuse or health At least one substance abuse or health department administrator from 48 states department administrator from 48 states and the District of Columbia and the District of Columbia (96%).(96%).
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 INHIV/AIDS, HCV & STI-RELATED SERVICES INSUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269)CTN ADMINISTRATOR RESPONSES (N=269)
HIV/AIDSHIV/AIDS HCVHCV STIsSTIs
n (%)n (%) n (%)n (%) n (%)n (%)Risk AssessmentRisk Assessment 224 (89)224 (89) 194 (77)194 (77) 195 (77)195 (77)
Patient EducationPatient Education 226 (84)226 (84) 200 (74)200 (74) 205 (76)205 (76)
Patient CounselingPatient Counseling 178 (66)178 (66) 159 (59)159 (59) 163 (60)163 (60)
History & Physical History & Physical ExaminationExamination
150 (56)150 (56) 135 (50)135 (50) 133 (49)133 (49)
Biological Biological AssessmentsAssessments
131 (49)131 (49) 93 (34)93 (34) 109 (40)109 (40)
PharmacotherapiePharmacotherapies Administered/ s Administered/ PrescribedPrescribed
103 (38)103 (38) 78 (29)78 (29) 92 (34)92 (34)
Clinical MonitoringClinical Monitoring 117 (43)117 (43) 95 (35)95 (35) 105 (39)105 (39)
PRELIMINARY RESULTSPRELIMINARY RESULTS: TREATMENT : TREATMENT PROGRAM CHARACTERISTICS BY HIV/AIDS, PROGRAM CHARACTERISTICS BY HIV/AIDS, HCV & STI-RELATED SERVICES:HCV & STI-RELATED SERVICES:
For-For-ProfitProfit
Non-Non-ProfitProfit
ResidentiResidentialal
Drug FreeDrug Free MethadonMethadonee
n (%)n (%) n (%)n (%) n (%)n (%) n (%)n (%) n (%)n (%)
HIV HIV Provider Provider EducationEducation
15 (93)15 (93) 146 146 (75)(75)
59 (82) 59 (82) 105 (74)105 (74) 61 (82)61 (82)
HCV Patient HCV Patient CounselingCounseling
13 (87)13 (87) 114 114 (57)(57)
48 (66)48 (66) 92 (63)92 (63) 65 (87)65 (87)
STI Patient STI Patient CounselingCounseling
13 (87)13 (87) 123 123 (62)(62)
54 (73)54 (73) 92 (63)92 (63) 61 (82)61 (82)
STI STI Biological Biological AssessmentAssessmentss
12 (80)12 (80) 76 (38)76 (38) 33 (45)33 (45) 51 (35)51 (35) 56 (74)56 (74)
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between Treatment Relationship Between Treatment Program (TP) Ownership & Program (TP) Ownership & Service ProvisionService Provision
• TP OwnershipTP Ownership– 78%78% Not For Profit Not For Profit– 6%6% For Profit For Profit
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
77%77% Provide the Service Provide the Service– In States Without In States Without
Guidelines/Regulations/Policies: Guidelines/Regulations/Policies: 65%65% Provide Provide the Servicethe Service
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Relationship Between State Policy & Treatment Program (TP) Policy & Treatment Program (TP) Provision of HIV Provider Provision of HIV Provider EducationEducation• State Administrator RespondentsState Administrator Respondents
– 67%67% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
77%77% Provide the Service Provide the Service– In States Without In States Without
Guidelines/Regulations/Policies: Guidelines/Regulations/Policies: 65%65% Provide Provide the Servicethe Service
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Relationship Between State Policy & TP HCV Patient Risk Policy & TP HCV Patient Risk AssessmentAssessment• State Administrator RespondentsState Administrator Respondents
– 53%53% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
79%79% of Programs Provide the Service of Programs Provide the Service– In States Without Guidelines/Regulations/Policies: In States Without Guidelines/Regulations/Policies:
65%65% of Programs Provide the Service of Programs Provide the Service
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Policy Relationship Between State Policy & Treatment Program (TP) HCV & Treatment Program (TP) HCV Biological TestingBiological Testing• State Administrator RespondentsState Administrator Respondents
– 26%26% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
43%43% Provide the Service Provide the Service– In States Without Guidelines/Regulations/Policies: In States Without Guidelines/Regulations/Policies:
32%32% Provide the Service Provide the Service
PRELIMINARY RESULTS:PRELIMINARY RESULTS: Relationship Between State Policy Relationship Between State Policy & Treatment Program (TP) STI & Treatment Program (TP) STI Patient CounselingPatient Counseling• State Administrator RespondentsState Administrator Respondents
– 41%41% Reported Guidelines/Regulations/Policies Reported Guidelines/Regulations/Policies
• TP Administrator RespondentsTP Administrator Respondents– In States With Guidelines/Regulations/Policies: In States With Guidelines/Regulations/Policies:
70%70% of Programs Provide the Service of Programs Provide the Service– In States Without In States Without
Guidelines/Regulations/Policies: Guidelines/Regulations/Policies: 76%76% of of Programs Provide the ServicePrograms Provide the Service
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 agencies.for-profit, for-profit, and public agencies.– a substantial proportion of substance a substantial proportion of substance
abuse treatment programs of all sizes.abuse treatment programs of all sizes.
SUMMARYSUMMARY• Staffing patterns (medical and non-Staffing patterns (medical and non-
medical) are quite varied.medical) are quite varied.
• There is… There is… – substantial variation in the % of substantial variation in the % of
programs offering the various services programs offering the various services for a particular infection group,for a particular infection group,
– consistency in the % of programs consistency in the % of programs offering a particular service for all three offering a particular service for all three infection groups.infection groups.
SUMMARYSUMMARY• Significant opportunities exist to explore Significant opportunities exist to explore
associations between the HIV/AIDS, HCV & associations between the HIV/AIDS, HCV & STI-related services offered andSTI-related services offered and– Other substance abuse treatment program Other substance abuse treatment program
characteristicscharacteristics– CTP Characteristics (funding, staffing)CTP Characteristics (funding, staffing)– Clinician Characteristics (training, knowledge, Clinician Characteristics (training, knowledge,
behavior)behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-
Related ServicesRelated Services– State Regulatory GuidelinesState Regulatory Guidelines
...And… THERE IS MORE DATA