Characteristics%20of%20Screening,%20Evaluation,%20and%20Treatment%20of%20HIV/AIDS,%20Hepatitis%20C%20Viral%20Infections,%20and%20Sexually%20Transmitted%20Infections%20in%20Substance%20Abuse%20Treatment%20Programs%20(NIDA%20CTN-0012)

1
Characteristics of Screening, Evaluation, and
Treatment of HIV/AIDS, Hepatitis C Viral
Infections, and Sexually Transmitted Infections
in Substance Abuse Treatment Programs (NIDA
CTN-0012)

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

Poster Presentations at the American Public
Health Association, Philadelphia, PA and American
College of Neuropsychopharmacology, Kona, Hawaii,
December, 2005
2
ABSTRACT
Introduction In the US, users of illicit drugs
will largely sustain the epidemics of HIV/AIDS,
hepatitis C, and sexually transmitted infections.
Substance abuse treatment programs can play a
major role in stemming these epidemics. A
nationwide CTN study, sponsored by NIDA, examines
these three infection groups from the perspective
of administrators and clinicians working in
substance abuse treatment programs. The NIDA CTN
has over 100 Community Treatment Programs (CTPs)
with over 300 discreet substance abuse treatment
sites in 17 nodes across the US. Methods Three
surveys were developed one each for substance
abuse treatment program administrators and
clinicians, and one for state health and
substance abuse department administrators. These
surveys looked at service availability,
government mandates, funding, and other key
elements involved in evaluating and caring for
patients in each of the three infection groups.
Results Completed surveys were obtained from 269
administrators and 1723 clinicians working at
substance abuse treatment sites. At the state
level, completed surveys were returned by
administrators from 48 states and the District of
Columbia. Preliminary data is presented.
Summary This study will allow for examination of
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 data and other information
can then be used to encourage best practices in
treating these epidemic infections.
3
ACKNOWLEDGEMENTS

• Research Supported by National Institute on Drug
  Abuse (NIDA) as part of a Cooperative Agreement
  (1U10DA013046) with the NIDA CTN and other
  Protocol Team members consisting of
• Randy Seewald, MD Cheryl Smith, MD Frank
  McCorry, PhD Dennis McCarty, PhD Donald Calsyn,
  PhD Leonard Handelsman, MD Steve Kipnis, MD
• Patrick McAuliffe, MBA, LADC Al Hassen, MSW
  Karen Reese, CAC-AD
• Shirley Irons Kathlene Tracy, PhD

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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 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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STUDY RATIONALE

• HIV/HCV/STI major causes of excess morbidity and
  mortality in the US
• Substance abuse a major vehicle for the
  transmission of infection
• Scope of, and challenges to identifying,
  counseling, and treating persons with these
  infections in substance abuse treatment will
  assist in developing effective interventions

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IMPORTANT ABREVIATIONS

• AIDS Acquired Immunodeficiency Syndrome
• HIV Human Immunodeficiency Virus
• HCV Hepatitis C Virus
• STI Sexually Transmitted Infections
• CTP Community Treatment Program
• CTN Clinical Trials Network
• SOP Standard Operating Procedures
• IRB Institutional (Human Subject) Review Board

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IMPORTANT DEFINITIONS

• 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
• Medical vs. Non-Medical Clinical Staff
• Expert Clinical Staff

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PRIMARY OBJECTIVES

• TO DESCRIBE
• Range of Infection-Related Services Available
• CTP Characteristics (funding, staffing)
• Clinician Characteristics (training, knowledge,
  behavior)
• Opinions
• Perceived Barriers to Providing Infection-Related
  Services
• State Regulatory Guidelines
• TO EXAMINE ASSOCIATIONS BETWEEN
• CTPs Availability of Selected Infection
  Services, and
• Other Constructs Listed Above

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DESIGN AND POPULATION

• STUDY DESIGN
• 3 Cross-sectional Surveys
• Descriptive Exploratory
• STUDY POPULATION
• CTP Administrators
• CTP Clinicians
• 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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Clinician Surveys
Statistician selects Clinicians from Treatment
Programs based on contact information provided by
Administrators
Clinician surveys mailed
Randomization
Clinician completes survey online or mails to
Data Center
Gathering sessions held for Clinicians to
complete surveys
Completed surveys mailed to Data Center
Data Center contacts non-responders after 30
days flagged as non-responders after four weekly
failed attempts
If non-responder is a randomly selected
Clinician, the next eligible Clinician on the
selection list is sent a survey
Data Center contacts Clinicians to resolve any
data queries

Data Center monitors the data entry of Clinicians
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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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MEASUREMENTS ANALYTICAL METHODS

• SAMPLING METHODOLOGYAt Each CTP
• All Expert Clinicians Designated by the CTP
• 10 randomly sampled Non-Expert Clinicians,
• in a ratio of MedicalNon-Medical reflecting
  that of
• the CTPs clinical staff
• ANALYTIC METHODOLOGIES
• Experts will be analyzed separately
• Clinicians may decline next randomly
• selected person will be asked to participate

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STATISTICAL ELEMENTS

• Sample Size and Precision of the Estimated Mean
• Analytic Plan
• Descriptive stats for survey variables
• Principal Component or Cluster or Factor Analysis
  to group and reduce the number of variables
• Structural Equation Models to test for
  associations

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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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HIV/AIDS, HCV STI-RELATED SERVICES INSUBSTANCE
ABUSE TREATMENT PROGRAMS NIDA CTN ADMINISTRATOR
RESPONSES (N269)
HIV/AIDS HCV STIs
n () n () n ()
Risk Assessment 224 (89) 194 (77) 195 (77)
Patient Education 226 (84) 200 (74) 205 (76)
Patient Counseling 178 (66) 159 (59) 163 (60)
History Physical Examination 150 (56) 135 (50) 133 (49)
Biological Assessments 131 (49) 93 (34) 109 (40)
Pharmacotherapies Administered/ Prescribed 103 (38) 78 (29) 92 (34)
Clinical Monitoring 117 (43) 95 (35) 105 (39)
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PRELIMINARY RESULTS TREATMENT PROGRAM
CHARACTERISTICS BY HIV/AIDS, HCV STI-RELATED
SERVICES
For-Profit Non-Profit Residential Drug Free Methadone
n () n () n () n () n ()
HIV Provider Education 15 (93) 146 (75) 59 (82) 105 (74) 61 (82)
HCV Patient Counseling 13 (87) 114 (57) 48 (66) 92 (63) 65 (87)
STI Patient Counseling 13 (87) 123 (62) 54 (73) 92 (63) 61 (82)
STI Biological Assessments 12 (80) 76 (38) 33 (45) 51 (35) 56 (74)

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PRELIMINARY RESULTS Relationship Between
Treatment Program (TP) Ownership Service
Provision

• TP Ownership
• 78 Not For Profit
• 6 For Profit
• TP Administrator Respondents
• In States With Guidelines/Regulations/Policies
  77 Provide the Service
• In States Without Guidelines/Regulations/Policies
  65 Provide the Service

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PRELIMINARY RESULTS Relationship Between State
Policy Treatment Program (TP) Provision of HIV
Provider Education

• State Administrator Respondents
• 67 Reported Guidelines/Regulations/Policies
• TP Administrator Respondents
• In States With Guidelines/Regulations/Policies
  77 Provide the Service
• In States Without Guidelines/Regulations/Policies
  65 Provide the Service

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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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PRELIMINARY RESULTS Relationship Between State
Policy Treatment Program (TP) STI Patient
Counseling

• State Administrator Respondents
• 41 Reported Guidelines/Regulations/Policies
• TP Administrator Respondents
• In States With Guidelines/Regulations/Policies
  70 of Programs Provide the Service
• In States Without Guidelines/Regulations/Policies
  76 of Programs Provide the Service

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SUMMARY

• Most HIV/AIDS, HCV STI-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.

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SUMMARY

• Staffing patterns (medical and non-medical) are
  quite varied.
• There is
• substantial variation in the of programs
  offering the various services for a particular
  infection group,
• consistency in the of programs offering a
  particular service for all three infection groups.

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SUMMARY

• Significant opportunities exist to explore
  associations between the HIV/AIDS, HCV
  STI-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
• State Regulatory Guidelines