Study documents

A data collection form is completed by the sites at the time of enrolment and hereafter a standardized data collection form is completed once annually. All data collection is in the browser-based electronic CRF data collection platform in REDCap. Access to a test version of this form is available upon request. 
 

For each patient, the date of HIV diagnosis and way of transmission is captured. The date of diagnosis of all AIDS-defining diseases is recorded, using the 1993 Centers for Disease Control and Prevention definitions. Further, the date of starting and stopping each antiretroviral drug is recorded, as is the use of drugs for prophylaxis against opportunistic infections. All CD4 lymphocyte counts and viral load measurements are requested at every follow-up and a range of other laboratory values. Further, data on non-AIDS defining diseases, adverse events of anti-HIV drugs, and causes of death (CoDe) are collected. In addition, a plasma sample is requested from all patients once a year. This plasma sample is stored locally at minus 80 degrees centigrade, and intermittently shipped to the central repository at the coordinating centre in Copenhagen.
 

All sites complete the follow-up forms within a two-month period. An updated version of the database is usually available 3 months later, allowing the study to provide almost real-time data on the patients followed.