Cohort profile: the German ClinSurv HIV project--a multicentre open clinical cohort study supplementing national HIV surveillance.
BACKGROUND
New forms of HIV/AIDS therapy require new surveillance instruments to meet shifting public health demands. The Clinical Surveillance of HIV Disease (ClinSurv HIV) project was established in 1999 as a collaboration between major HIV treatment centres in Germany and the Robert Koch Institute (RKI). The project contributes to national HIV surveillance and focuses on the changing epidemiology of HIV/AIDS after the introduction of new therapies in 1995.


METHODS
ClinSurv HIV is designed as an open multicentre observational cohort study of HIV-infected patients. Anonymized data on diagnoses, treatment and laboratory parameters are collected in a standardized format. Data are currently sampled biannually via 11 centres specializing in HIV diagnosis and care within the legal framework of the German Protection against Infection Act [Infektionsschutzgesetz (IfSG)].


RESULTS
A total of 14874 patients were enrolled in the study by 30 June 2009. Of these, 10221 patients (68.7%) were enrolled after 1 January 1999 and 6006 patients (40.4%) were known to have been diagnosed as positive for HIV before 1999. Evaluation indicators, such as the number of newly enrolled patients per half-year period, loss to follow-up, completeness of data per case, availability of data per possible clinical contact, and internal quality control parameters, show a very stable evolution in the cohort, which although open, can be observed. Comparison with the national HIV surveillance data suggests a high degree of representativeness according to major demographic variables.


CONCLUSIONS
Bearing in mind the obvious strengths and weaknesses discussed, the German ClinSurv HIV cohort provides a broad range of research opportunities in the field of HIV/AIDS both within Germany and in international collaborative research.
Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
J
J
Bätzing-Feigenbaum
C
C
Kollan
A
A
Kühne
D
D
Matysiak-Klose
B
B
Gunsenheimer-Bartmeyer
O
O
Hamouda
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D003625:Data Collection; D005260:Female; D005858:Germany / Q000453:epidemiology; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology*; D015497:HIV-1; D006801:Humans; D008297:Male; D011634:Public Health; D011786:Quality Control; D012042:Registries / Q000706:statistics & numerical data; D018571:Sentinel Surveillance
D019380:Anti-HIV Agents