The Women's Interagency HIV Study (WINS) is a large, comprehensive cohort study designed to investigate a spectrum of questions relating to the pathogenesis and natural history of HIV infection among women in the era of highly active antiretroviral therapy. The purpose of this application is to extend support of the WIHS Data Management and Analysis Center (WDMAC) that will continue to provide leadership in contributing epidemiological and statistical expertise to the WIHS research agenda, provide a stable and efficient data management system, and provide coordination of study protocols and WIHS investigator initiatives to enhance the quality and validity of the data and the scientific research in the WIHS.
The specific aims of WDMAC are: (1) To provide leadership in the design, analysis, and presentation of WIHS study data and to develop novel statistical and epidemiologic methodology applicable to the scientific research initiatives of the WIHS;(2) To establish and implement methods to coordinate research initiatives and scientific presentations, to facilitate communication among WIHS and external investigators, to orchestrate revisions of study protocols and forms, and to produce study-wide profiles of cohort characteristics (WIHS Dossier), the study database and ongoing research initiatives (WDMAC Report), and scientific publications (WIHS Archives);(3) To establish, implement, and maintain a web-based data management system encompassing data entry, transmission, documentation, editing, storage, summarization, and dissemination. Components of this aim include establishing a system for tracking the storage and transfer of biological specimens at national repositories, producing annual public data sets, and conducting training in methods that facilitates the appropriate use of study data for local research;(4) To implement a quality assurance program in partnership with the clinical sites that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines. This program will monitor study-wide quality and promote adherence and training for standardized data collection and management programs. As both a scientific partner and center for operations, this project serves to increase the breadth of initiatives that can be pursued, and the depth to which research questions are pursued, within WIHS.
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