This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to continue serving as the Data Coordinating Center (DCC) for the NIMH MultiSite HIV/STD Prevention Trial for African American Couples (AAC) Study. Originally, limited DCC activities were funded within the R01 at the U. of Pennsylvania, but in order to support the expanded U01 level of multisite coordination, progressed to an expanded role, and are now being proposed within a separate DCC application. The proposed DCC will continue providing administrative and project management, biostatistical, data management and research computing leadership for this randomized controlled trial (RCT) across each of four study sites;Columbia University, Emory University, University of California, Los Angeles and the University of Pennsylvania. Additionally, the DCC will continue to serve as the overarching infrastructure to facilitate common protocol administration and data collection procedures across the four study sites. The proposed DCC is uniquely positioned with experience-based scientific, technical and administrative leadership to coordinate this AAC project, as it has been doing since the original grant was funded in 2002. To continue supporting this multisite RCT, the DCC will provide technical expertise necessary to implement and support data collection, quality assurance (QA), and reporting via a secure data management system (DMS) deployed at the sites on existing hardware, including a novel Automated Computer Assisted Self Interview (ACASI) system with audio and visual guidance. This DMS will support (at each site) couple screening and enrollment, data collection, and tracking of couples and data transfer to the DCC. In addition, the DCC will continue to support the DMS used to enter data recorded on paper case report forms, forwarded to the DCC. The DCC will execute procedures for data security and access, QA, storage, back-up, disaster recovery, and will provide periodic monitoring and QA reports (e.g., quarterly). The DCC will provide the scientific design and analysis, logistical and administrative support by organizing meetings of Steering Committees, coordinating development and distribution of RCT materials, and providing the NIMH Program Office, and the Data and Safety Monitoring Board (DSMB) with interim data summaries, and monitoring reports focused on the conduct and quality assurance of the RCT. Further, the DCC will provide interim and final statistical analyses, as well as collaboration on all scientific publications.
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NIH ExPorter