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
ACKNOWLEDGEMENTS
PATIENTS AND STAFF OF
THE ADDICTION
RESEARCH AND
TREATMENT
CORPORATION, A
COMMUNITY-BASED
SUBSTANCE ABUSE
SERVICE AGENCY
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
STUDY SITES
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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
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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
Drug Abuse Treatment Clinical Trials Network
17 Nodes with 116 Community Treatment Agencies
Reaching into 26 States!
Seattle
Portland
Detroit
New York
City
Denver
Los Angeles
Philadelphia
Baltimore/Richmond
Cincinnati
San Francisco
(CA/AZ Node)
Raleigh/
Durham
Albuquerque
Charleston
Miami
CTN Sites
Boston
New Haven
Long Island
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
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
IMPORTANT ABREVIATIONS
•
•
•
•
•
HCV = Hepatitis C Virus
CTP = Community Treatment Program
CTN = Clinical Trials Network
SOP = Standard Operating Procedures
IRB = Institutional (Human Subject) Review Board
IMPORTANT DEFINITIONS
•Community Treatment Programs =
•Substance Abuse Treatment Agencies
Treatment Program=
Modalities
Service A
Treatment Program=
Modalities
Service A
Treatment Program=
Modalities
Service A
Service B
Service D
Service C
Service E
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
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
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
ETHICAL, REGULATORY
& ADMINISTRATIVE
CONSIDERATIONS
• Expedited IRB Approval
• Waiver of Informed Consent
• Training for Node Protocol Managers
STUDY PROCEDURES
• Node Protocol Managers
• Information Sheet In Lieu of Informed
Consent
• Survey Administration
– Paper or Electronic
– Central data acquisition
Administrator Surveys
Ensure
IRB
approval
Contact CTP Directors for
Treatment Program and
Administrator contact
information
Data Center contacts Administrators
that have not completed the survey
or Clinician contact information
within 30 days
For Administrators that
refuse to participate or still
have not responded after
two additional weeks, the
Node Protocol Manager
alerts the Node Principal
Investigator
Survey materials
mailed to
Administrators
Node Protocol Manager contacts
Administrators that have not responded
within two weeks
Node Protocol
Managers
contact nonresponder
Administrators
weekly
After four weekly
attempts,
Administrators flagged
as non-responders by
the Data Center
Administrator completes
survey online or mails to
Data Center;
Administrator enters
contact information for
Clinicians
Data Center
contacts
Administrators
to resolve any
data queries
State Surveys
Project Manager
enters State
Administrator
contact information
into the Data
Center system
After four weekly
attempts to contact
State Administrators, the
Project Manager flags
them as non-responders
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
Data Center reviews data
and communicates any
issues to Project Manager
Project Manager
contacts State
Administrators to
resolve data queries
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%)
Characteristics of Treatment Programs
Characteristic
Number of Surveys with
Valid Responses
Corporate structure
Private not-for-profit
Private for profit
Government
Other
268
Largest source of revenue
County/local grants
State funds
Medicaid
Federal grants
VA Benefits
Medicare
Private contracts/insurance
Self-pay
Other
Unknown
269
Number (%) of
Treatment Programs*
212 (78.5)
15 (5.6)
36 (13.4)
6 (2.2)
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
Characteristics of Treatment Programs
Characteristic
Number of Surveys with
Valid Responses
Patient census
≤500
500 – 1000
>1000
Number (%) of
Treatment
Programs*
250
145 (53.9)
52 (19.3)
53 (19.7)
Addiction Services Offered #
256
242
257
259
Inpatient or residential services
Outpatient pharmacotherapy
Other outpatient services
Outreach & support services
Medical Staff
Non-Medical Staff
148 (55.0)
89 (33.1)
206 (76.6)
227 (84.4)
0
1
2-3
4-7
8+
55 (20.4)
31 (11.5)
64 (23.8)
54 (20.1)
57 (21.2)
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
HCV-RELATED SERVICES IN SUBSTANCE ABUSE
TREATMENT PROGRAMS: NIDA CTN
ADMINISTRATOR RESPONSES (N=269)
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)
PRELIMINARY RESULTS: TREATMENT
PROGRAM CHARACTERISTICS BY HCVRELATED PATIENT COUNSELING
SERVICES
TREATMENT PROGRAM CHARACTERISTICS
ForProfit
Offer HCV
Patient
Counseling
n (%)
NonProfit
13 (87) 114 (57)
Residential
Drug
Free
Opiate
Agonist
Rx
48 (66)
92 (63)
65 (87)
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
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
RELATIONSHIP BETWEEN STATE POLICIES,
GUIDELINES, & REGULATIONS AND HCVRELATED SERVICES IN SUBSTANCE ABUSE
TREATMENT PROGRAMS
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)
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
SUMMARY
• Most HCV-related services are offered by:
– a substantial proportion of private not-forprofit, for-profit, and public agencies
– a substantial proportion of substance abuse
treatment programs of all sizes
• Staffing patterns (medical and nonmedical) are quite varied
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
BOTTOM LINE
• Many treatment programs offer an array of
HCV-related services
• A significant number of programs offer no HCVrelated 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
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
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@artcny.org
– Steven Kritz, MD – the Project Director: skritz@artcny.org