HCV-Related Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network

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HCV-Related Services in Substance Abuse Treatment
Settings The NIDA Clinical Trials Network

• Lawrence S. Brown Jr., MD, MPH, FASAM
• Addiction Research and Treatment Corporation,
  Brooklyn, NY and
• Weill Medical College, Cornell University, New
  York, NY

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

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

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ACKNOWLEDGEMENTS

• Research Supported by National Institute on Drug
  Abuse (NIDA) as part of a Cooperative Agreement
  (1U10DA013046) with the NIDA CTN and Protocol
  Team members consisting of
• Steven Kritz, MD John Rotrosen, MD Jim
  Robinson, MEd Edmund Bini, MD, MPH Jeff
  Goldsmith, MD Dennis McCarty, PhD Donald
  Calsyn, PhD Patrick McAuliffe, MBA, LADC Karen
  Reese, CAC-AD
• Shirley Irons Sherryl Baker, PhD Kathlene
  Tracy, PhD

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STUDY SITES

• New York Node New York University, New York, NY
• South Carolina Node Medical University of South
  Carolina, Charleston, SC
• Florida Node University of Miami, Coral Gables,
  FL
• Great Lakes Node Wayne State University,
  Detroit, MI
• Ohio Valley Node University of Cincinnati,
  Cincinnati, OH
• Rocky Mountain Node University of CO Health
  Sciences Center, Denver, CO
• New England Node Yale University, New Haven, CT
• Delaware Valley Node University of Pennsylvania,
  Philadelphia, PA
• Mid-Atlantic Node Johns Hopkins Univ.,
  Baltimore, MD Medical College
• of
  Virginia, Richmond
• Pacific Region Node University of California at
  Los Angeles, CA
• Oregon Node Oregon Health Sciences University,
  Portland, OR
• Washington Node University of Washington,
  Seattle, WA
• Long Island Node NY State Psychiatric Institute,
  New York, NY
• North Carolina Node Duke University,
  Raleigh/Durham, NC
• Southwest Node University of New Mexico,
  Albuquerque, NM
• Northern New England Node McLean Hospital,
  Belmont, MA
• California-Arizona Node University of California
  at San Francisco, CA

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17 Nodes with 116 Community Treatment Agencies
Reaching into 26 States!
Drug Abuse Treatment Clinical Trials Network
Seattle
Portland
New York City
Detroit
Boston
New Haven
Denver
Long Island
Philadelphia
Cincinnati
San Francisco (CA/AZ Node)
Baltimore/Richmond
Raleigh/ Durham
Albuquerque
Los Angeles
Charleston
Miami
CTN Sites
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STUDY RATIONALE

• HCV the major cause of hepatic failure requiring
  liver transplantation in the US
• Substance use a major vehicle for HCV
  transmission
• Scope of, and challenges to identifying,
  counseling and treating persons with HCV in
  substance abuse treatment will assist in
  developing effective interventions

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PREVIOUS RESEARCH

• Focused on a single treatment program or a local
  group of programs
• The 2 national multi-site assessments did not
  include associations to state policies,
  guidelines of regulations or information from
  clinicians

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IMPORTANT ABREVIATIONS

• HCV Hepatitis C Virus
• CTP Community Treatment Program
• CTN Clinical Trials Network
• SOP Standard Operating Procedures
• IRB Institutional (Human Subject) Review Board

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IMPORTANT DEFINITIONS
Service A
Service A
Service A
Service B
Service C
Service E
Service D
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IMPORTANT TERMS

• Treatment Program vs. NIDA CTN CTP
• Services Assessed
• Provider Education
• Patient Education
• Patient Risk Assessment
• Patient Counseling
• Patient Medical History Physical Exam
• Patient Biological Testing
• Patient Treatment
• Patient Monitoring

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PRIMARY OBJECTIVES

• TO DESCRIBE
• Range of HCV-Related Services Available
• CTP Characteristics (funding, staffing)
• Perceived Barriers to Providing HCV-Related
  Services
• State Policies, Regulations, or Guidelines
• TO EXAMINE ASSOCIATIONS BETWEEN
• CTPs Availability of Selected HCV-Related
  Services and State Policies, Guidelines,
  Regulations

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DESIGN AND POPULATION

• STUDY DESIGN
• 2 Cross-sectional Surveys
• Descriptive Exploratory
• STUDY POPULATION
• CTP Administrators
• Administrators of State Health Departments and
  State Substance Abuse Agencies

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ETHICAL, REGULATORY ADMINISTRATIVE
CONSIDERATIONS

• Expedited IRB Approval
• Waiver of Informed Consent
• Training for Node Protocol Managers

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STUDY PROCEDURES

• Node Protocol Managers
• Information Sheet In Lieu of Informed Consent
• Survey Administration
• Paper or Electronic
• Central data acquisition

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Administrator Surveys
Administrator completes survey online or mails to
Data Center Administrator enters contact
information for Clinicians
Contact CTP Directors for Treatment Program and
Administrator contact information
Ensure IRB approval
Survey materials mailed to Administrators
Data Center contacts Administrators that have not
completed the survey or Clinician contact
information within 30 days

Node Protocol Manager contacts Administrators
that have not responded within two weeks
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 Admin
istrators 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

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State Surveys
Project Manager enters State Administrator
contact information into the Data Center system
Data Center mails survey material to State
Administrators
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
Data Center reviews data and communicates any
issues to Project Manager
Project Manager contacts State Administrators to
resolve data queries
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RESULTS

• 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)
• At least one substance abuse or health department
  administrator from 48 states and the District of
  Columbia (96)

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Characteristics of Treatment Programs
Characteristic Number 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
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Characteristics of Treatment Programs
Characteristic Number of Surveys with Valid Responses Number () of Treatment Programs
Patient census 500 500 1000 gt1000 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
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) 59 (21.9) 64 (23.8)
Percentages do not total 100 due to rounding
and non-respondents Responses were not mutually
exclusive for this item
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HCV-RELATED SERVICES IN SUBSTANCE ABUSETREATMENT
PROGRAMS NIDA CTN ADMINISTRATOR RESPONSES (N269)
Service Offered
n ()
Risk Assessment 194 (77)
Patient Education 200 (74)
Patient Counseling 159 (59)
History Physical Examination 135 (50)
Biological Assessments 93 (34)
Pharmacotherapies Administered/ Prescribed 78 (29)
Clinical Monitoring 95 (35)
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PRELIMINARY RESULTS TREATMENT PROGRAM
CHARACTERISTICS BY HCV-RELATED PATIENT COUNSELING
SERVICES
TREATMENT PROGRAM CHARACTERISTICS TREATMENT PROGRAM CHARACTERISTICS TREATMENT PROGRAM CHARACTERISTICS TREATMENT PROGRAM CHARACTERISTICS TREATMENT PROGRAM CHARACTERISTICS
For-Profit Non-Profit Residential Drug Free Opiate Agonist Rx
Offer HCV Patient Counseling n () 13 (87) 114 (57) 48 (66) 92 (63) 65 (87)

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PRELIMINARY RESULTS Relationship Between State
Policy TP HCV Patient Risk Assessment

• State Administrator Respondents
• 53 Reported Guidelines/Regulations/Policies
• 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

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PRELIMINARY RESULTS Relationship Between State
Policy Treatment Program (TP) HCV Biological
Testing

• State Administrator Respondents
• 26 Reported Guidelines/Regulations/Policies
• TP Administrator Respondents
• In States With Guidelines/Regulations/Policies
  43 Provide the Service
• In States Without Guidelines/Regulations/Policies
  32 Provide the Service

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RELATIONSHIP BETWEEN STATE POLICIES, GUIDELINES,
REGULATIONS AND HCV-RELATED SERVICES IN
SUBSTANCE ABUSE TREATMENT PROGRAMS
State Policies/Guidelines/Regs State Policies/Guidelines/Regs
Services YES NO
Provider Education 113 (69) 57 (65)
Patient Education 140 (80) 58 (75)
Risk Assessment 147 (79) 45 (65)
History Physical Examination 62 (57) 54 (50)
Biological Testing 48 (43) 45 (32)
Counseling 93 (73) 65 (52)
Treatment 38 (56) 40 (25)
Monitoring 38 (69) 57 (29)
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STUDY LIMITATIONS

• Generalizability of Results
• Consistent with 2 previous published assessments
• Does not include utilization, cost, efficiency,
  or effectiveness of HCV-related services
• Hypothesis generating

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SUMMARY

• Most HCV-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
• Staffing patterns (medical and non-medical) are
  quite varied

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SUMMARY

• There is substantial variation in the
  availability of HCV-related services in CTN
  treatment programs
• The availability of most services appeared to be
  unrelated to state policies, guidelines, or
  regulations.
• The availability of counseling, treatment and
  monitoring appeared to be associated with the
  presence state guidelines, policies and mandates

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BOTTOM LINE

• Many treatment programs offer an array of
  HCV-related services
• A significant number of programs offer no
  HCV-related services.
• State guidance appears to have some influence on
  the availability of HCV-related services
• A number of hypotheses opportunities remain to
  be proposed, pursued, and answered
• These are preliminary results of a larger study

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BOTTOM LINE

• Significant opportunities exist to explore other
  associations between the HCV-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

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FOR MORE INFORMATION ABOUT THIS STUDY

• AT THIS MEETING
• Poster- P4-
• AT OTHER PROFESSIONAL MEETINGS
• American Society on Addiction Medicine, San
  Diego, CA 2006
• College on Problems of Drug Dependence,
  Scottsdale, AZ, 2006
• PEER-REVIEWED PUBLICATIONS
• Accepted by Journal of Substance Abuse Treatment
• CONTACTING STUDY PERSONNEL
• Dr. Brown, the Principal Investigator
  lbrown_at_artcny.org
• Steven Kritz, MD the Project Director
  skritz_at_artcny.org