The clinical treatment of HIV/AIDS in the era of Highly Active Anti-Retroviral Therapy (HAART) is extremely dynamic with unprecedented combinations of therapies and a myriad of patient and virologic responses to therapy. Long-term outcomes research is necessary to provide clinicians with up-to-date information on the best strategies to employ in their patients'individual situations. Historically, evidence for clinical care decisions has been generated through the conduct of randomized controlled clinical trials, epidemiology-based prospective clinical cohorts, and anecdotal reports. A new approach that will synergize with these methods is outcomes research based on the utilization of data derived directly from newly developed electronic medical record (EMR) systems and compiling such data into novel research networks. Such EMR systems are already in existence at several Centers for AIDS Research (CFAR) sites in the United States. The CFAR Network of Integrated Clinical Systems (CNICS) project is the first such resource network that can substantially contribute to the contemporary HIV research agenda. As a clinic-based research network, CNICS directly reflects the outcomes of clinical decisions and management options used daily in the care of HIV infected individuals. Unlike data collected in structured interviews or through retrospective medical record review, CNICS assures a broader range of information associated with the rapidly changing course of HIV disease management through collection of data at the point of care. The CNICS project supports a data system that is a central repository of verified and quality-controlled data from the EMRs at seven CFAR sites. The EMR data recorded for individual patient care are made available through CNICS for population-based outcomes research, which facilitates networking and contributes to the standardization of data contained in the CNICS data system. CNICS is also developing a specimen repository linked with clinical data from the sites'EMRs. CNICS is a unique resource for HIV clinical, translational, and basic research and will provide the infrastructure and data to address the challenging and rapidly evolving issues in HIV care and research. The principle goals of this proposal are to build and support the CNICS infrastructure, to address the challenging research agenda of the evolving HIV epidemic, to prepare for the expansion of CNICS by developing standard operating procedures and software tools to facilitate data quality control and transmission, to expand CNICS by 8 to 10 sites within 5 years, and to serve as a resource for the development of similar research networks.
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