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ClinSurv-HIV Dr. Osamah Hamouda, MPH Department for Infectious - PowerPoint PPT Presentation

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Clinical Surveillance of HIV-Disease ClinSurv-HIV Dr. Osamah Hamouda, MPH Department for Infectious Disease Epidemiology HIV/AIDS and STI Unit AREVIR-Meeting und Arbeitstreffen des Verbundprojektes Monitoring von resistenten HIV in

  1. Clinical Surveillance of HIV-Disease ClinSurv-HIV Dr. Osamah Hamouda, MPH Department for Infectious Disease Epidemiology HIV/AIDS and STI Unit AREVIR-Meeting und Arbeitstreffen des Verbundprojektes „Monitoring von resistenten HIV in Deutschland“ Bonn, 20. April 2007

  2. ClinSurv-HIV - Objectives Primary objectives • assess the demographic structure of treated HIV patients and monitor over time • monitor changes in occurrence of HIV related diseases • evaluate the different ART regimen and their effects outside controlled clinical trials • ascertain potential risk factors for disease progression Secondary objectives • estimate the total number of HIV patients receiving care • provide a database for future research projects

  3. ClinSurv-HIV - Study Design • Prospective multicentre observational study • Start: 01.01.1999 • Inclusion of all HIV patients irrespective of stage of disease treated at major HIV treatment centres in Germany • Local data collection in established databases of the centres • No informed consent necessary (limited amount of data) • Approval obtained by the Federal Data Protection Commissioner

  4. ClinSurv-HIV – Participating Centres currently 15 active centres Berlin Hamburg Auguste-Viktoria-Klinikum IFI Universitätsklinikum Eppendorf Charité Campus Virchow IPM–Studycenter Bochum Ruhr Universität Bochum Kiel Städt. Krankenhaus Kiel Bonn Universitätsklinik Bonn Köln Klinik I der Universität Köln Düsseldorf Universitätsklinikum Düsseldorf München Essen Universitätsklinik München Universitätsklinikum Essen Regensburg Universitätsklinikum Regensburg Hannover Med. Hochschule Hannover Rostock Universitätsklinikum Rostock

  5. ClinSurv-HIV - Study Design Regional distribution of 15 active centres Incidence of newly diagnosed HIV infections per 100.000 pop. in 2006 Kiel 1 Rostock 1 Hamburg 3 Berlin Hannover 2 1 Essen 1 Bochum D'dorf 1 1 Köln Bonn 1 1 0 - <0,001 0,001 - <0,01 Regensburg 0,01 - <0,1 1 0,1 - <1 1 - <10 München 1 10 - <100

  6. ClinSurv-HIV – Methods General Data Management • Transfer of anonymous data bi-annually in a predefined specific format • Use of an alphanumeric identifier (RKI-Code), to identify duplicates and supplement data • Databases of four RKI projects have been combined into unified HIV/AIDS database – AIDS-case registry (1982) – HIV-Seroconverter Study (1997) – HIV-Documentation Nordrhein (1999) – ClinSurv HIV (1999)

  7. HIV/AIDS Databases at RKI Dataflow • Clinics with electronic DB • Clinics without electronic DB • Private practice networks (MVZ) • Other private practices HIV- HIV-Doku- AIDS- RKI Serokon- mentation Fall- ClinSurv verter Nordrhein register Studie RKI HIV/AIDS Datenbank

  8. ClinSurv-HIV – Methods Data • Demographic data RKI-Code, sex, date of birth (mm/yyyy), PLZ, country of origin, date of first visit • HIV Infection Transmission group, date of first positive AB-test Clinical data • HIV-associated and AIDS-defining diagnoses, • Lab data CD4- und CD8- cell count, viral load • Antiretroviral Therapy ART-drugs, start and stop dates, reason for drug/regime change

  9. ClinSurv-HIV – Methods Data structure for data submission (schematic) Fully compatible with HICDEP format

  10. ClinSurv-HIV – Methods Data quality assurance • Definition of minimal standard for remuneration • Specific criteria for plausibility and completeness for all variables • Inconsistent or incomplete data are not included into database • Regular standardised feedback to the centres • Querry lists and request to correct data within six weeks

  11. ClinSurv-HIV – Methods ClinSurv case definition • Confirmed positive HIV-antibody test • Information on RKI-code, sex, date of birth (mm/yyyy), zipcode (3 digits), country of origin and • At least one documented event in Lab-, Diagnosis-, or Medication tables after 01.01.1999

  12. ClinSurv- HIV – Results Study patients (01.01.1999 bis 30.06.2006) 17,619 cases (60,455 PYF ) 6,403 Patients with first visit before 1999 11,216 Patients with first visit since 1999 • 1999 1614 • 2000 1638 • 2001 1487 • 2002 1518 • 2003 1483 • 2004 1548 • 2005 1414 • 2006 504 (up to 30.06.2006)

  13. ClinSurv-HIV – Results Duplicates (reports from different ClinSurv centres) ClinSurv inclusion criteria (1.1.1999) 17.619 patients 1451 pts. multiples (8,2%) of those 1354 duplicates 89 triplicates 5 four-fold 3 five-fold

  14. ClinSurv-HIV – Results Study patients: Demographics Total number 17.619 age at FV Male 14.222 ( 80,7% ) 37 yr Female 3.395 (19,3%) 32 yr Origin Germany 12.818 ( 72,8% ) Western Europe 619 ( 3,5%) Central Europe 504 ( 2,9%) Eastern Europe, Asia 475 ( 2,7%) Africa, Middle East 1.542 ( 8,8%) America, Oceania 285 ( 1,6%) Unknown 1.376 ( 7,8%)

  15. ClinSurv-HIV – Results Transmission group by half year of first visit (n= 17.619) 100% Unkn./NRI MTC 80% HPL prob. Hetero 60% Hetero Hemo/Transf IDU 40% MSM 20% 0% 2 2 1 9 1 2 1 2 1 2 1 2 1 2 1 1 - - - - - - - - - - - - - - - 9 9 9 0 0 1 1 2 2 3 3 4 4 5 5 6 9 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 1 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 < 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2

  16. ClinSurv-HIV – Results Mean age by sex and half year of FV (N=11.216) 44 42 40 Men Age 38 Women 36 34 32 30 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 - - - - - - - - - - - - - - - 9 9 0 0 1 1 2 2 3 3 4 4 5 5 6 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 half year of FV

  17. ClinSurv-HIV – Results CD4-cell count/µl by half year of FV (N = 8.126 / 11.216) 100% >= 500 80% 350-499 60% 200-349 40% < 200 20% 0% 1 1 1 1 1 1 1 1 - - - - - - - - 2 3 4 5 6 9 0 1 9 0 0 0 0 0 0 0 9 0 0 0 0 0 0 0 1 2 2 2 2 2 2 2 half year of first visit (Wert mit kleinstem Abstand im Range -90/+30Tage von Erstvorstellung; MW = 2,75 Tage, Median = 0 Tage)

  18. ClinSurv-HIV – Results Viral load (N=6958) and CD4 cell count (N=8126) Median at first visit by CDC stage CD4 N/µl VL log10/ml 700 6 CD4 - non B,C 600 CD4 - B 5 CD4 - C 500 4 VL - non B,C 400 VL - B 3 300 VL - C 2 200 1 100 0 0 1 1 1 1 1 1 1 1 - - - - - - - - 9 0 1 2 3 4 5 6 9 0 0 0 0 0 0 0 9 0 0 0 0 0 0 0 1 2 2 2 2 2 2 2 Wert mit kleinstem Abstand im Range -90/+30Tage von Erstvorstellung CD4, MW = 2,75 Tage, Median = 0 Tage; VL, MW = 3,0 Tage, Median = 0 Tage

  19. ClinSurv-HIV – Results CDC - stage at first visit (N=11.216) 100% C B 80% non BC unk. 60% 40% 20% 0% 1 1 1 1 1 1 1 1 - - - - - - - - 9 0 1 2 3 4 5 6 9 0 0 0 0 0 0 0 9 0 0 0 0 0 0 0 1 2 2 2 2 2 2 2 half year of first visit neu aufgenommene Patienten seit dem 01.01.1999, Erkrankungen bis Erstvorstellung + 30 Tage

  20. ClinSurv-HIV – Results Incidence rates of AIDS-defining diagnoses/100 PYF 20 Cervix-Ca 18 HIV-Enc. Diagnoses/100 PYF 16 Wasting 14 NHL 12 KS 10 OI 8 6 4 2 0 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 - - - - - - - - - - - - - - - 9 9 0 0 1 1 2 2 3 3 4 4 5 5 6 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 9 9 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 Half year of follow up

  21. Acknowledgements RKI HIV/AIDS and STI Unit Christian Kollan Andrea Kühne ClinSurv Steering group Prof. Dr. Brockmeyer Prof. Dr. Rockstroh Prof. Dr. Bogner Prof. Dr. Stoll funded by • BMG 1999; since 2000 RKI bundget • BMBF, KompetenzNetz HIV/AIDS 2003 - 2005

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