Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort)

The Italian MASTER (MAnagement Standardizzato di TErapia antiRetrovirale, standardized management of antiretroviral therapy) cohort is a hospital-based multicentre, open, dynamic HIV cohort established in the mid 1990s, with retrospective patient enrolment from 1986 to 1997 and subsequent prospective recruitment. At that time, no institutional system of surveillance of HIV infection was available, apart from the registration of AIDS cases. Accurate, precise and up-to-date data on HIV infection were therefore needed. To this end, we established a network of various HIV infection treatment centres in Italy, using a common clinical chart and an electronic database for data collection and management. The MASTER cohort enrols all HIV-infected patients, both treatment naïve and treatment experienced, in care at several HIV clinics throughout the country in order to represent the epidemiological and clinical scenario of HIV infection in Italy. A Steering Committee guarantees the scientific accuracy of the cohort. The Committee is made up of members from each centre and controls data quality by verifying the completeness, accuracy and updating of data collected by each centre. Furthermore, a working group proposes new studies, carries them out, analyses and discusses the findings and writes the final papers, under the supervision of the Steering Committee. The committee also verifies the consistency of the final paper with the initial proposal before its submission to a journal for publication. In performing these activities, the working group is supported by a data manager, a statistician and an epidemiologist. The main objectives of this cohort study are: (i) to create a hospital-based database of HIV-positive subjects for clinical and epidemiological research projects; (ii) to monitor the epidemiological pattern of HIV infection in Italy; (iii) to monitor highly active antiretroviral therapy (HAART) effectiveness and safety, and HIV drug resistance emergence; (iv) to investigate the predictive role of traditional and new risk factors for developing chronic diseases, particularly in HIV and HCV co-infected subjects; (v) to evaluate the prognostic role of traditional and new biomarkers for survival in HIV patients with cancer and other chronic diseases.