Clinicians Involved in Screening, Clinicians Involved in Screening, Evaluation, and Treatment of Evaluation, and Treatment of

HIV/AIDS, Hepatitis C Viral Infection, HIV/AIDS, Hepatitis C Viral Infection, and Sexually Transmitted Infections in and Sexually Transmitted Infections in

Substance Abuse Treatment Substance Abuse Treatment Programs: the National Drug Abuse Programs: the National Drug Abuse Treatment Clinical Trials Network Treatment Clinical Trials Network

L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. R.J. Goldsmith, MD; E. Bini, MD, MPH; J. Robinson, MEd, and the NIDA Clinical Trials Robinson, MEd, and the NIDA Clinical Trials Network Infections Study (CTN-0012) TeamNetwork Infections Study (CTN-0012) Team

Poster Presentation at the Annual Meeting of the American Poster Presentation at the Annual Meeting of the American

Society on Addiction Medicine, San Diego, CA – May 5, 2006Society on Addiction Medicine, San Diego, CA – May 5, 2006

ABSTRACTABSTRACTIn the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C (HCV), and sexually transmitted infections (STI). Substance abuse treatment programs can (HCV), and sexually transmitted infections (STI). Substance abuse treatment programs can play a major role in stemming these epidemics. A nationwide study, sponsored by the play a major role in stemming these epidemics. A nationwide study, sponsored by the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) examines these three National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) examines these three infection groups from the perspective of administrators and clinicians working in substance infection groups from the perspective of administrators and clinicians working in substance abuse treatment programs, and the states within which they are located. The NIDA CTN abuse treatment programs, and the states within which they are located. The NIDA CTN has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across the US. Three surveys were developed; one each abuse treatment sites in 17 nodes across the US. Three surveys were developed; one each for substance abuse treatment program administrators and clinicians, and one for state health for substance abuse treatment program administrators and clinicians, and one for state health and substance abuse department administrators. This report examines HIV/AIDS, HCV, and and substance abuse department administrators. This report examines HIV/AIDS, HCV, and STI-related services provided by substance abuse treatment programs in the NIDA CTN STI-related services provided by substance abuse treatment programs in the NIDA CTN from the perspective of the clinicians, medical and non-medical, expert and non-expert, from the perspective of the clinicians, medical and non-medical, expert and non-expert, working in these programs. The clinician survey looked at practices, program guidelines, working in these programs. The clinician survey looked at practices, program guidelines, knowledge, barriers, and opinions of clinicians caring for substance abusers within their knowledge, barriers, and opinions of clinicians caring for substance abusers within their program. Completed surveys were obtained from 1719 of 2207 targeted clinicians working program. Completed surveys were obtained from 1719 of 2207 targeted clinicians working at 265 substance abuse treatment sites. The breakdown of completed surveys was: (1) at 265 substance abuse treatment sites. The breakdown of completed surveys was: (1) medical expert: 251; (2) medical non-expert: 115; (3) non-medical expert: 522; and (4) non-medical expert: 251; (2) medical non-expert: 115; (3) non-medical expert: 522; and (4) non-medical non-expert: 831. The extensive data obtained from this group of clinicians will be medical non-expert: 831. The extensive data obtained from this group of clinicians will be presented to inform public policy to encourage “best practices” in treating these epidemic presented to inform public policy to encourage “best practices” in treating these epidemic infections. 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-AD; Sherryl Baker, PhDKaren Reese, CAC-AD; Sherryl Baker, PhD

– 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• HIV = Human Immunodeficiency VirusHIV = Human Immunodeficiency Virus

• AIDS = Acquired Immunodeficiency SyndromeAIDS = Acquired Immunodeficiency Syndrome

• 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– Clinician Characteristics (training, knowledge, Clinician Characteristics (training, knowledge,

behavior)behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-

Related ServicesRelated Services

• TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS 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– Cross-sectional Survey Cross-sectional Survey – Descriptive & ExploratoryDescriptive & Exploratory

• STUDY POPULATIONSTUDY POPULATION– CTP CliniciansCTP Clinicians

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

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

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

• Surveys Obtained from 1719 Surveys Obtained from 1719 Clinicians of 2207 Targeted Clinicians of 2207 Targeted (78%)(78%)

• 831 Non-Medical Non-Experts831 Non-Medical Non-Experts (48%) (48%)

• 115 Medical Non-Experts115 Medical Non-Experts (7%) (7%)

• 522 Non-Medical Experts522 Non-Medical Experts (30%) (30%)

• 251 Medical Experts251 Medical Experts (15%) (15%)

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

SERVICESERVICE n (%)n (%) n (%)n (%) n (%)n (%)Provider EducationProvider Education 186 (69)186 (69) 171 (63)171 (63) 155 (57)155 (57)

Patient EducationPatient Education 226 (84)226 (84) 200 (74)200 (74) 205 (76)205 (76)

Risk AssessmentRisk Assessment 224 (89)224 (89) 194 (77)194 (77) 195 (77)195 (77)

History & Physical History & Physical ExaminationExamination

150 (56)150 (56) 135 (50)135 (50) 133 (49)133 (49)

TestingTesting 131 (49)131 (49) 93 (34)93 (34) 109 (40)109 (40)

CounselingCounseling 178 (66)178 (66) 159 (59)159 (59) 163 (60)163 (60)

TreatmentTreatment 103 (38)103 (38) 78 (29)78 (29) 92 (34)92 (34)

MonitoringMonitoring 117 (43)117 (43) 95 (35)95 (35) 105 (39)105 (39)

CLARITY OF HIV GUIDELINES: % OF CLARITY OF HIV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

50%50% 55%55% 56%56% 49%49% 52%52%

Patient Patient EducationEducation

57%57% 60%60% 66%66% 54%54% 60%60%

Risk Risk AssessmentAssessment

57%57% 54%54% 65%65% 59%59% 60%60%

History & History & Physical Physical ExamExam

56%56% 66%66% 53%53% 76%76% 58%58%

TestingTesting 35%35% 47%47% 42%42% 59%59% 41%41%CounselingCounseling 49%49% 52%52% 54%54% 58%58% 52%52%TreatmentTreatment 43%43% 55%55% 46%46% 55%55% 47% 47% MonitoringMonitoring 39%39% 42%42% 38%38% 51%51% 41%41%

CLARITY OF HCV GUIDELINES: % OF CLARITY OF HCV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

42%42% 53%53% 43%43% 45%45% 43%43%

Patient Patient EducationEducation

48%48% 54%54% 51%51% 48%48% 49%49%

Risk Risk AssessmentAssessment

48%48% 50%50% 54%54% 54%54% 51%51%

History & History & Physical Physical ExamExam

53%53% 64%64% 50%50% 74%74% 56%56%

TestingTesting 32%32% 44%44% 37%37% 54%54% 37%37%CounselingCounseling 41%41% 47%47% 45%45% 51%51% 44%44%TreatmentTreatment 39%39% 52%52% 40%40% 48%48% 41% 41% MonitoringMonitoring 35%35% 42%42% 32%32% 43%43% 36%36%

CLARITY OF STI GUIDELINES: % OF CLARITY OF STI GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLINICIANS SCORING GUIDELINES AS

CLEARCLEAR

NON -NON - EXPERT EXPERT EXP EXP

ERTERT

SERVICSERVICEE

Non-Non-MedMed

MedicalMedical Non-MedNon-Med MedicalMedical OVERALLOVERALL

Provider Provider EducationEducation

40%40% 50%50% 41%41% 40%40% 41%41%

Patient Patient EducationEducation

47%47% 51%51% 50%50% 41%41% 47%47%

Risk Risk AssessmentAssessment

46%46% 48%48% 51%51% 46%46% 48%48%

History & History & Physical Physical ExamExam

49%49% 64%64% 49%49% 73%73% 53%53%

TestingTesting 28%28% 42%42% 35%35% 50%50% 35%35%CounselingCounseling 39%39% 45%45% 44%44% 44%44% 41%41%TreatmentTreatment 37%37% 53%53% 40%40% 51%51% 41% 41% MonitoringMonitoring 32%32% 42%42% 31%31% 43%43% 34%34%

SUMMARYSUMMARY

• 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 groupfor 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 groupsinfection groups

SUMMARYSUMMARY

• Clarity of guidelines for the 8 targeted Clarity of guidelines for the 8 targeted services is generally about 50% or less services is generally about 50% or less for all three infection groups, with the for all three infection groups, with the following exceptions:following exceptions:– History & Physical Exam (medical experts History & Physical Exam (medical experts

and non-experts) for all three infection and non-experts) for all three infection groupsgroups

– Patient Education and Risk Assessment Patient Education and Risk Assessment (non-medical experts) for HIV(non-medical experts) for HIV

SUMMARYSUMMARY• Significant opportunities exist to Significant opportunities exist to

explore other associations between explore other associations between the HIV/AIDS, HCV & STI-related the HIV/AIDS, HCV & STI-related services offered and…services offered and…– Clinician Characteristics (training, Clinician Characteristics (training,

knowledge, behavior)knowledge, behavior)– OpinionsOpinions– Perceived Barriers to Providing Infection-Perceived Barriers to Providing Infection-

Related ServicesRelated Services