HCV-Related Services in HCV-Related Services in Substance Abuse Treatment Substance Abuse Treatment

Settings: Settings: The NIDA Clinical Trials The NIDA Clinical Trials

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Lawrence S. Brown Jr., MD, MPH, FASAMLawrence S. Brown Jr., MD, MPH, FASAM

Addiction Research and Treatment Corporation, Brooklyn, Addiction Research and Treatment Corporation, Brooklyn, NY; and NY; and

Weill Medical College, Cornell University, New York, NYWeill Medical College, Cornell University, New York, NY

Oral Presentation at the American Association for the Treatment of Opioid DependenceAtlanta, GA - April 25, 2006

ACKNOWLEDGEMENACKNOWLEDGEMENTSTSPATIENTS AND STAFF PATIENTS AND STAFF

OF THE ADDICTION OF THE ADDICTION RESEARCH AND RESEARCH AND TREATMENT TREATMENT CORPORATION, A CORPORATION, A COMMUNITY-BASED COMMUNITY-BASED SUBSTANCE ABUSE SUBSTANCE ABUSE SERVICE AGENCYSERVICE AGENCY

ACKNOWLEDGEMENTSACKNOWLEDGEMENTS• Research Supported by National Institute on Research Supported by National Institute on

Drug Abuse (NIDA) as part of a Cooperative Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046)Agreement (1U10DA013046) with the NIDA with the NIDA CTN and Protocol Team members consisting CTN and Protocol Team members consisting of:of:– Steven Kritz, MD; John Rotrosen, MD; Jim Steven Kritz, MD; John Rotrosen, MD; Jim

Robinson, MEd; Edmund Bini, MD, MPH; Jeff Robinson, MEd; Edmund Bini, MD, MPH; Jeff Goldsmith, MD; Dennis McCarty, PhD; Donald Goldsmith, MD; Dennis McCarty, PhD; Donald Calsyn, PhD; Patrick McAuliffe, MBA, LADC; Karen Calsyn, PhD; Patrick McAuliffe, MBA, LADC; Karen Reese, CAC-ADReese, CAC-AD

– Shirley Irons; Sherryl Baker, PhD; Shirley Irons; Sherryl Baker, PhD; Kathlene Tracy, Kathlene Tracy, PhD PhD

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

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

• HCV: the major cause of hepatic failure HCV: the major cause of hepatic failure requiring liver transplantation in the US requiring liver transplantation in the US

• Substance use: a major vehicle for HCV Substance use: a major vehicle for HCV transmission transmission

• Scope of, and challenges to identifying, Scope of, and challenges to identifying, counseling and treating persons with counseling and treating persons with HCV in substance abuse treatment will HCV in substance abuse treatment will assist in developing effective assist in developing effective interventionsinterventions

PREVIOUS RESEARCHPREVIOUS RESEARCH

• Focused on a single treatment Focused on a single treatment program or a local group of programsprogram or a local group of programs

• The 2 national multi-site assessments The 2 national multi-site assessments did not include associations to state did not include associations to state policies, guidelines of regulations or policies, guidelines of regulations or information from cliniciansinformation from clinicians

IMPORTANT IMPORTANT ABREVIATIONSABREVIATIONS

• HCV = Hepatitis C VirusHCV = Hepatitis C Virus

• 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 DEFINITIONSIMPORTANT DEFINITIONS

•Community Treatment Programs =

•Substance Abuse Treatment Agencies

Treatment Program= Modalities

Treatment Program= Modalities

Treatment Program= Modalities

Service AService AService A

Service E

Service BService CService D

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 CounselingPatient Counseling

– Patient Medical History & Physical ExamPatient Medical History & Physical Exam

– Patient Biological TestingPatient Biological Testing

– Patient TreatmentPatient Treatment

– Patient MonitoringPatient Monitoring

PRIMARY OBJECTIVESPRIMARY OBJECTIVES• TO DESCRIBE:TO DESCRIBE:

– Range of HCV-Related Services AvailableRange of HCV-Related Services Available– CTP Characteristics (funding, staffing)CTP Characteristics (funding, staffing)– Perceived Barriers to Providing HCV-Related Perceived Barriers to Providing HCV-Related

ServicesServices– State Policies, Regulations, or GuidelinesState Policies, Regulations, or Guidelines

• TO EXAMINE ASSOCIATIONS TO EXAMINE ASSOCIATIONS BETWEEN: BETWEEN: – CTPs’ Availability of Selected HCV-Related CTPs’ Availability of Selected HCV-Related

Services and State Policies, Guidelines, Services and State Policies, Guidelines, RegulationsRegulations

DESIGN AND DESIGN AND POPULATIONPOPULATION

•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 State Substance Departments and State Substance Abuse AgenciesAbuse Agencies

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 PROCEDURESSTUDY PROCEDURES

• 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

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

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

HCV-RELATED SERVICES IN SUBSTANCE HCV-RELATED SERVICES IN SUBSTANCE ABUSEABUSETREATMENT PROGRAMS: NIDA CTN TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269)ADMINISTRATOR RESPONSES (N=269)

Service OfferedService Offered

n (%)n (%)Risk AssessmentRisk Assessment 194 (77)194 (77)

Patient EducationPatient Education 200 (74)200 (74)

Patient CounselingPatient Counseling 159 (59)159 (59)

History & Physical ExaminationHistory & Physical Examination 135 (50)135 (50)

Biological AssessmentsBiological Assessments 93 (34)93 (34)

Pharmacotherapies Pharmacotherapies Administered/ PrescribedAdministered/ Prescribed

78 (29)78 (29)

Clinical MonitoringClinical Monitoring 95 (35)95 (35)

PRELIMINARY RESULTSPRELIMINARY RESULTS: TREATMENT : TREATMENT PROGRAM CHARACTERISTICS BY PROGRAM CHARACTERISTICS BY HCV-RELATED PATIENT COUNSELING HCV-RELATED PATIENT COUNSELING SERVICESSERVICES

TREATMENT PROGRAM TREATMENT PROGRAM CHARACTERISTICSCHARACTERISTICS

For-For-ProfitProfit

Non-Non-ProfitProfit

ResidentiResidentialal

Drug Drug FreeFree

OpiateOpiate

Agonist Agonist RxRx

Offer HCV Offer HCV Patient Patient CounselinCounselingg

n (%)n (%)

13 13 (87)(87)

114 114 (57)(57)

48 (66)48 (66) 92 (63)92 (63) 65 (87)65 (87)

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

RELATIONSHIP BETWEEN STATE POLICIES, RELATIONSHIP BETWEEN STATE POLICIES, GUIDELINES, & REGULATIONS AND HCV-GUIDELINES, & REGULATIONS AND HCV-

RELATED SERVICES IN SUBSTANCE ABUSE RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS TREATMENT PROGRAMS

State Policies/Guidelines/RegsState Policies/Guidelines/Regs

ServicesServices YESYES NONOProvider EducationProvider Education 113 (69)113 (69) 57 (65)57 (65)

Patient EducationPatient Education 140 (80)140 (80) 58 (75)58 (75)

Risk AssessmentRisk Assessment 147 (79)147 (79) 45 (65)45 (65)

History & Physical History & Physical ExaminationExamination

62 (57)62 (57) 54 (50)54 (50)

Biological TestingBiological Testing 48 (43)48 (43) 45 (32)45 (32)

CounselingCounseling 93 (73)93 (73) 65 (52)65 (52)

TreatmentTreatment 38 (56)38 (56) 40 (25)40 (25)

MonitoringMonitoring 38 (69)38 (69) 57 (29)57 (29)

STUDY STUDY LIMITATIONSLIMITATIONS

• Generalizability of ResultsGeneralizability of Results

– Consistent with 2 previous published Consistent with 2 previous published assessmentsassessments

• Does not include utilization, cost, Does not include utilization, cost, efficiency, or effectiveness of HCV-efficiency, or effectiveness of HCV-related servicesrelated services

– Hypothesis generatingHypothesis generating

SUMMARYSUMMARY• Most HCV-related services are Most HCV-related services are

offered by: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• There is substantial variation in the There is substantial variation in the

availability of HCV-related services in availability of HCV-related services in CTN treatment programsCTN treatment programs

• The availability of most services The availability of most services appeared to be unrelated to state appeared to be unrelated to state policies, guidelines, or regulations.policies, guidelines, or regulations.

• The availability of counseling, The availability of counseling, treatment and monitoring appeared to treatment and monitoring appeared to be associated with the presence state be associated with the presence state guidelines, policies and mandatesguidelines, policies and mandates

BOTTOM LINEBOTTOM LINE• Many treatment programs offer an array of Many treatment programs offer an array of

HCV-related servicesHCV-related services

• A significant number of programs offer no A significant number of programs offer no HCV-related services.HCV-related services.

• State guidance appears to have some State guidance appears to have some influence on the availability of HCV-related influence on the availability of HCV-related servicesservices

• A number of hypotheses & opportunities A number of hypotheses & opportunities remain to be proposed, pursued, and remain to be proposed, pursued, and answeredanswered

• These are These are preliminarypreliminary results of a larger study results of a larger study

BOTTOM LINEBOTTOM LINE• Significant opportunities exist to explore Significant opportunities exist to explore

other associations between the HCV-other associations between the HCV-related services offered andrelated 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

FOR MORE FOR MORE INFORMATION ABOUT THIS INFORMATION ABOUT THIS

STUDYSTUDY• AT THIS MEETINGAT THIS MEETING

– Poster- P4-Poster- P4-

• AT OTHER PROFESSIONAL MEETINGSAT OTHER PROFESSIONAL MEETINGS– American Society on Addiction Medicine, San Diego, CA American Society on Addiction Medicine, San Diego, CA

20062006– College on Problems of Drug Dependence, Scottsdale, College on Problems of Drug Dependence, Scottsdale,

AZ, 2006AZ, 2006

• PEER-REVIEWED PUBLICATIONSPEER-REVIEWED PUBLICATIONS– Accepted by Journal of Substance Abuse TreatmentAccepted by Journal of Substance Abuse Treatment

• CONTACTING STUDY PERSONNELCONTACTING STUDY PERSONNEL– Dr. Brown, the Principal Investigator: Dr. Brown, the Principal Investigator: lbrown@artcny.orglbrown@artcny.org– Steven Kritz, MD – the Project Director: Steven Kritz, MD – the Project Director: skritz@artcny.orgskritz@artcny.org