Characteristics of Screening, Evaluation, and Treatment of HIV/AIDS,  Hepatitis C Viral Infections, and Sexually  Transmit...
ABSTRACT Introduction:  In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C, and...
ACKNOWLEDGEMENTS <ul><li>Research Supported by National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement ...
17 Nodes with 116 Community Treatment Agencies Reaching into 26 States! Drug Abuse Treatment Clinical Trials Network Phila...
STUDY SITES <ul><li>New York Node:   New York University, New York, NY </li></ul><ul><li>South Carolina Node:   Medical Un...
STUDY RATIONALE <ul><li>HIV/HCV/STI: major causes of excess morbidity and mortality in the US </li></ul><ul><li>Substance ...
IMPORTANT ABREVIATIONS <ul><li>AIDS = Acquired Immunodeficiency Syndrome </li></ul><ul><li>HIV =  Human Immunodeficiency V...
IMPORTANT DEFINITIONS <ul><li>Treatment Program vs. NIDA CTN CTP </li></ul><ul><li>Services Assessed </li></ul><ul><ul><li...
PRIMARY OBJECTIVES <ul><li>TO DESCRIBE:   </li></ul><ul><ul><li>Range of Infection-Related Services Available </li></ul></...
DESIGN AND POPULATION <ul><li>STUDY DESIGN </li></ul><ul><ul><li>3  Cross-sectional Surveys  </li></ul></ul><ul><ul><li>De...
ETHICAL, REGULATORY & ADMINISTRATIVE CONSIDERATIONS <ul><li>Expedited IRB Approval  </li></ul><ul><li>Waiver of Informed C...
STUDY PROCEDURES <ul><li>Node Protocol Managers  </li></ul><ul><li>Information Sheet In Lieu of Informed Consent </li></ul...
Administrator Surveys Contact CTP Directors for  Treatment Program and  Administrator contact  information Survey material...
Clinician Surveys Statistician selects Clinicians from Treatment Programs based on contact information provided by Adminis...
State Surveys Data Center mails survey material to State Administrators Project Manager enters State Administrator contact...
MEASUREMENTS & ANALYTICAL METHODS <ul><li>SAMPLING METHODOLOGY: At Each CTP … </li></ul><ul><ul><li>All ‘Expert’ Clinician...
STATISTICAL ELEMENTS <ul><li>Sample Size and Precision of the Estimated Mean </li></ul><ul><li>Analytic Plan </li></ul><ul...
RESULTS <ul><li>269 administrators responded  (84%)  out of 319 substance abuse program administrators surveyed, from 95 C...
Characteristics of Treatment Programs  * Percentages do not total 100% due to rounding and non-respondents   45 (16.7) 103...
Characteristics of Treatment Programs  * Percentages do not total 100% due to rounding and non-respondents #  Responses we...
HIV/AIDS, HCV & STI-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269) 105 (...
PRELIMINARY RESULTS : TREATMENT PROGRAM CHARACTERISTICS BY HIV/AIDS, HCV & STI-RELATED SERVICES: 56 (74) 61 (82) 65 (87) 6...
PRELIMINARY RESULTS:  Relationship Between Treatment Program (TP) Ownership & Service Provision <ul><li>TP Ownership </li>...
PRELIMINARY RESULTS:  Relationship Between State Policy & Treatment Program (TP) Provision of HIV Provider Education <ul><...
PRELIMINARY RESULTS:  Relationship Between State Policy & TP HCV Patient Risk Assessment <ul><li>State Administrator Respo...
PRELIMINARY RESULTS:  Relationship Between State Policy & Treatment Program (TP) HCV Biological Testing <ul><li>State Admi...
PRELIMINARY RESULTS:  Relationship Between State Policy & Treatment Program (TP) STI Patient Counseling <ul><li>State Admi...
SUMMARY <ul><li>Most HIV/AIDS, HCV & STI-related services are offered by: </li></ul><ul><ul><li>a substantial proportion o...
SUMMARY <ul><li>Staffing patterns (medical and non-medical) are quite varied. </li></ul><ul><li>There is…  </li></ul><ul><...
SUMMARY <ul><li>Significant opportunities exist to explore associations between the HIV/AIDS, HCV & STI-related services o...
...And… THERE IS MORE DATA
Upcoming SlideShare
Loading in …5
×

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)

859 views
750 views

Published on

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
859
On SlideShare
0
From Embeds
0
Number of Embeds
3
Actions
Shares
0
Downloads
18
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • PROTOCOL TEAM MEMBERSHIP TO DATE
  • PROTOCOL TEAM MEMBERSHIP TO DATE
  • Updated 3/7/01 (S.C. Node) Modified 1/11/01 – 14 Sites
  • 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)

    1. 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 Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, Cincinnati, OH; and Nathan Kline Institute, Orangeburg, NY
    2. 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. 3. ACKNOWLEDGEMENTS <ul><li>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: </li></ul><ul><ul><li>Randy Seewald, MD; Cheryl Smith, MD; Frank McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD </li></ul></ul><ul><ul><li>Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD </li></ul></ul><ul><ul><li>Shirley Irons; Kathlene Tracy, PhD </li></ul></ul>
    4. 4. 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States! 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
    5. 5. STUDY SITES <ul><li>New York Node: New York University, New York, NY </li></ul><ul><li>South Carolina Node: Medical University of South Carolina, Charleston, SC </li></ul><ul><li>Florida Node: University of Miami, Coral Gables, FL </li></ul><ul><li>Great Lakes Node: Wayne State University, Detroit, MI </li></ul><ul><li>Ohio Valley Node: University of Cincinnati, Cincinnati, OH </li></ul><ul><li>Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO </li></ul><ul><li>New England Node: Yale University, New Haven, CT </li></ul><ul><li>Delaware Valley Node: University of Pennsylvania, Philadelphia, PA </li></ul><ul><li>Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College </li></ul><ul><li>of Virginia, Richmond </li></ul><ul><li>Pacific Region Node: University of California at Los Angeles, CA </li></ul><ul><li>Oregon Node: Oregon Health Sciences University, Portland, OR </li></ul><ul><li>Washington Node: University of Washington, Seattle, WA </li></ul><ul><li>Long Island Node: NY State Psychiatric Institute, New York, NY </li></ul><ul><li>North Carolina Node: Duke University, Raleigh/Durham, NC </li></ul><ul><li>Southwest Node: University of New Mexico, Albuquerque, NM </li></ul><ul><li>Northern New England Node: McLean Hospital, Belmont, MA </li></ul><ul><li>California-Arizona Node: University of California at San Francisco, CA </li></ul>
    6. 6. STUDY RATIONALE <ul><li>HIV/HCV/STI: major causes of excess morbidity and mortality in the US </li></ul><ul><li>Substance abuse: a major vehicle for the transmission of infection </li></ul><ul><li>Scope of, and challenges to identifying, counseling, and treating persons with these infections in substance abuse treatment will assist in developing effective interventions </li></ul>
    7. 7. IMPORTANT ABREVIATIONS <ul><li>AIDS = Acquired Immunodeficiency Syndrome </li></ul><ul><li>HIV = Human Immunodeficiency Virus </li></ul><ul><li>HCV = Hepatitis C Virus </li></ul><ul><li>STI = Sexually Transmitted Infections </li></ul><ul><li>CTP = Community Treatment Program </li></ul><ul><li>CTN = Clinical Trials Network </li></ul><ul><li>SOP = Standard Operating Procedures </li></ul><ul><li>IRB = Institutional (Human Subject) Review Board </li></ul>
    8. 8. IMPORTANT DEFINITIONS <ul><li>Treatment Program vs. NIDA CTN CTP </li></ul><ul><li>Services Assessed </li></ul><ul><ul><li>Provider Education </li></ul></ul><ul><ul><li>Patient Education </li></ul></ul><ul><ul><li>Patient Risk Assessment </li></ul></ul><ul><ul><li>Patient Counseling </li></ul></ul><ul><ul><li>Patient Medical History & Physical Exam </li></ul></ul><ul><ul><li>Patient Biological Testing </li></ul></ul><ul><ul><li>Patient Treatment </li></ul></ul><ul><ul><li>Patient Monitoring </li></ul></ul><ul><li>Medical vs. Non-Medical Clinical Staff </li></ul><ul><li>‘ Expert’ Clinical Staff </li></ul>
    9. 9. PRIMARY OBJECTIVES <ul><li>TO DESCRIBE: </li></ul><ul><ul><li>Range of Infection-Related Services Available </li></ul></ul><ul><ul><li>CTP Characteristics (funding, staffing) </li></ul></ul><ul><ul><li>Clinician Characteristics (training, knowledge, behavior) </li></ul></ul><ul><ul><li>Opinions </li></ul></ul><ul><ul><li>Perceived Barriers to Providing Infection-Related Services </li></ul></ul><ul><ul><li>State Regulatory Guidelines </li></ul></ul><ul><li>TO EXAMINE ASSOCIATIONS BETWEEN: </li></ul><ul><ul><li>CTPs’ Availability of Selected Infection Services, and </li></ul></ul><ul><ul><li>Other Constructs Listed Above </li></ul></ul>
    10. 10. DESIGN AND POPULATION <ul><li>STUDY DESIGN </li></ul><ul><ul><li>3 Cross-sectional Surveys </li></ul></ul><ul><ul><li>Descriptive & Exploratory </li></ul></ul><ul><li>STUDY POPULATION </li></ul><ul><ul><li>CTP Administrators </li></ul></ul><ul><ul><li>CTP Clinicians </li></ul></ul><ul><ul><li>Administrators of State Health Departments and State Substance Abuse Agencies </li></ul></ul>
    11. 11. ETHICAL, REGULATORY & ADMINISTRATIVE CONSIDERATIONS <ul><li>Expedited IRB Approval </li></ul><ul><li>Waiver of Informed Consent </li></ul><ul><li>Training for Node Protocol Managers </li></ul>
    12. 12. STUDY PROCEDURES <ul><li>Node Protocol Managers </li></ul><ul><li>Information Sheet In Lieu of Informed Consent </li></ul><ul><li>Survey Administration </li></ul><ul><ul><li>Paper or Electronic </li></ul></ul><ul><ul><li>Central data acquisition </li></ul></ul>
    13. 13. Administrator Surveys Contact CTP Directors for Treatment Program and Administrator contact information Survey materials mailed to Administrators Ensure IRB approval 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 Administrators that have not completed the survey or Clinician contact information within 30 days 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 Administrators 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
    14. 14. Clinician Surveys Statistician selects Clinicians from Treatment Programs based on contact information provided by Administrators Clinician surveys mailed Gathering sessions held for Clinicians to complete surveys Clinician completes survey online or mails to Data Center 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 monitors the data entry of Clinicians Data Center contacts Clinicians to resolve any data queries Randomization
    15. 15. 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 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 Project Manager contacts State Administrators to resolve data queries Data Center reviews data and communicates any issues to Project Manager
    16. 16. MEASUREMENTS & ANALYTICAL METHODS <ul><li>SAMPLING METHODOLOGY: At Each CTP … </li></ul><ul><ul><li>All ‘Expert’ Clinicians Designated by the CTP </li></ul></ul><ul><ul><li>10 randomly sampled ‘Non-Expert’ Clinicians, </li></ul></ul><ul><ul><li>in a ratio of Medical:Non-Medical reflecting that of </li></ul></ul><ul><ul><li>the CTP’s clinical staff </li></ul></ul><ul><li>ANALYTIC METHODOLOGIES </li></ul><ul><ul><li>‘ Experts’ will be analyzed separately </li></ul></ul><ul><ul><li>Clinicians may decline; next randomly </li></ul></ul><ul><ul><li>selected person will be asked to participate </li></ul></ul>
    17. 17. STATISTICAL ELEMENTS <ul><li>Sample Size and Precision of the Estimated Mean </li></ul><ul><li>Analytic Plan </li></ul><ul><ul><li>Descriptive stats for survey variables </li></ul></ul><ul><ul><li>Principal Component or Cluster or Factor Analysis to group and reduce the number of variables </li></ul></ul><ul><ul><li>Structural Equation Models to test for associations </li></ul></ul>
    18. 18. RESULTS <ul><li>269 administrators responded (84%) out of 319 substance abuse program administrators surveyed, from 95 CTPs in the NIDA CTN, covering 26 states & DC </li></ul><ul><li>1723 clinicians of 2210 targeted (78%) </li></ul><ul><li>At least one substance abuse or health department administrator from 48 states and the District of Columbia (96%). </li></ul>
    19. 19. Characteristics of Treatment Programs * Percentages do not total 100% due to rounding and non-respondents 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) 269 Largest source of revenue County/local grants State funds Medicaid Federal grants VA Benefits Medicare Private contracts/insurance Self-pay Other Unknown 212 (78.5) 15 (5.6) 36 (13.4) 6 (2.2) 268 Corporate structure Private not-for-profit Private for profit Government Other Number (%) of Treatment Programs * Number of Surveys with Valid Responses Characteristic
    20. 20. Characteristics of Treatment Programs * Percentages do not total 100% due to rounding and non-respondents # Responses were not mutually exclusive for this item 79 (29.4) 59 (21.9) 59 (21.9) 64 (23.8) Non-Medical Staff 0-7 8-11 12-17 18+ 55 (20.4) 31 (11.5) 64 (23.8) 54 (20.1) 57 (21.2) Medical Staff 0 1 2-3 4-7 8+ 148 (55.0) 89 (33.1) 206 (76.6) 227 (84.4) 256 242 257 259 Addiction Services Offered # Inpatient or residential services Outpatient pharmacotherapy Other outpatient services Outreach & support services 145 (53.9) 52 (19.3) 53 (19.7) 250 Patient census ≤ 500 500 – 1000 >1000 Number (%) of Treatment Programs * Number of Surveys with Valid Responses Characteristic
    21. 21. HIV/AIDS, HCV & STI-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269) 105 (39) 95 (35) 117 (43) Clinical Monitoring 92 (34) 78 (29) 103 (38) Pharmacotherapies Administered/ Prescribed 109 (40) 93 (34) 131 (49) Biological Assessments 133 (49) 135 (50) 150 (56) History & Physical Examination 163 (60) 159 (59) 178 (66) Patient Counseling 205 (76) 200 (74) 226 (84) Patient Education 195 (77) 194 (77) 224 (89) Risk Assessment n (%) n (%) n (%) STIs HCV HIV/AIDS
    22. 22. PRELIMINARY RESULTS : TREATMENT PROGRAM CHARACTERISTICS BY HIV/AIDS, HCV & STI-RELATED SERVICES: 56 (74) 61 (82) 65 (87) 61 (82) n (%) Methadone 12 (80) 13 (87) 13 (87) 15 (93) n (%) For-Profit 51 (35) 33 (45) 76 (38) STI Biological Assessments 92 (63) 54 (73) 123 (62) STI Patient Counseling 92 (63) 48 (66) 114 (57) HCV Patient Counseling 105 (74) 59 (82) 146 (75) HIV Provider Education n (%) n (%) n (%) Drug Free Residential Non-Profit
    23. 23. PRELIMINARY RESULTS: Relationship Between Treatment Program (TP) Ownership & Service Provision <ul><li>TP Ownership </li></ul><ul><ul><li>78% Not For Profit </li></ul></ul><ul><ul><li>6% For Profit </li></ul></ul><ul><li>TP Administrator Respondents </li></ul><ul><ul><li>In States With Guidelines/Regulations/Policies: 77% Provide the Service </li></ul></ul><ul><ul><li>In States Without Guidelines/Regulations/Policies: 65% Provide the Service </li></ul></ul>
    24. 24. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) Provision of HIV Provider Education <ul><li>State Administrator Respondents </li></ul><ul><ul><li>67% Reported Guidelines/Regulations/Policies </li></ul></ul><ul><li>TP Administrator Respondents </li></ul><ul><ul><li>In States With Guidelines/Regulations/Policies: 77% Provide the Service </li></ul></ul><ul><ul><li>In States Without Guidelines/Regulations/Policies: 65% Provide the Service </li></ul></ul>
    25. 25. PRELIMINARY RESULTS: Relationship Between State Policy & TP HCV Patient Risk Assessment <ul><li>State Administrator Respondents </li></ul><ul><ul><li>53% Reported Guidelines/Regulations/Policies </li></ul></ul><ul><li>TP Administrator Respondents </li></ul><ul><ul><li>In States With Guidelines/Regulations/Policies: 79% of Programs Provide the Service </li></ul></ul><ul><ul><li>In States Without Guidelines/Regulations/Policies: 65% of Programs Provide the Service </li></ul></ul>
    26. 26. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) HCV Biological Testing <ul><li>State Administrator Respondents </li></ul><ul><ul><li>26% Reported Guidelines/Regulations/Policies </li></ul></ul><ul><li>TP Administrator Respondents </li></ul><ul><ul><li>In States With Guidelines/Regulations/Policies: 43% Provide the Service </li></ul></ul><ul><ul><li>In States Without Guidelines/Regulations/Policies: 32% Provide the Service </li></ul></ul>
    27. 27. PRELIMINARY RESULTS: Relationship Between State Policy & Treatment Program (TP) STI Patient Counseling <ul><li>State Administrator Respondents </li></ul><ul><ul><li>41% Reported Guidelines/Regulations/Policies </li></ul></ul><ul><li>TP Administrator Respondents </li></ul><ul><ul><li>In States With Guidelines/Regulations/Policies: 70% of Programs Provide the Service </li></ul></ul><ul><ul><li>In States Without Guidelines/Regulations/Policies: 76% of Programs Provide the Service </li></ul></ul>
    28. 28. SUMMARY <ul><li>Most HIV/AIDS, HCV & STI-related services are offered by: </li></ul><ul><ul><li>a substantial proportion of private not-for-profit, for-profit, and public agencies. </li></ul></ul><ul><ul><li>a substantial proportion of substance abuse treatment programs of all sizes. </li></ul></ul>
    29. 29. SUMMARY <ul><li>Staffing patterns (medical and non-medical) are quite varied. </li></ul><ul><li>There is… </li></ul><ul><ul><li>substantial variation in the % of programs offering the various services for a particular infection group, </li></ul></ul><ul><ul><li>consistency in the % of programs offering a particular service for all three infection groups. </li></ul></ul>
    30. 30. SUMMARY <ul><li>Significant opportunities exist to explore associations between the HIV/AIDS, HCV & STI-related services offered and </li></ul><ul><ul><li>Other substance abuse treatment program characteristics </li></ul></ul><ul><ul><li>CTP Characteristics (funding, staffing) </li></ul></ul><ul><ul><li>Clinician Characteristics (training, knowledge, behavior) </li></ul></ul><ul><ul><li>Opinions </li></ul></ul><ul><ul><li>Perceived Barriers to Providing Infection-Related Services </li></ul></ul><ul><ul><li>State Regulatory Guidelines </li></ul></ul>
    31. 31. ...And… THERE IS MORE DATA

    ×