The purpose of this application, submitted by the Research Triangle Institute (RTI), is to participate i proposed (RFA MH-90-06) Cooperative Agreement for Multi-Site Trials of Behavioral Strategies to Preven Further Spread of BEIV Infection in the role of the Coordinating Center (CC). The purpose of the cooperative agreement is to generate critical information for the development of m of prevention that can be applied to diverse populations at risk for HIV infection. The CC in this study expected to provide overall study coordination, including data management and statistical analysis, traini common procedures, and distribution of necessary study materials to all study sites. A five year multi collaborative study, divided into three phases, is envisaged. As the CC for the study, RTI will be involved in several aspects of the project. During the first phase study (first 12 months), RTI will contribute to the development of the plans for the common research d through the participation of their investigators in a leadership role in the development of the statistical as of the study design(s), procedures for field data collection, data processing and data analysis, quality control coordination and management of the studies. During Phase II, expected to last for 24 months, RTI contribute to the development and testing of evaluation procedures (enrollment procedures, data colle instruments, data acquisition procedures, procedures for processing, analyzing and reporting of the results monitoring the conduct of the studies). During Phase III, expected to last another 2 years, RTI staff involved in monitoring the studies, developing and maintaining the common data repository, processin analyzing the data and reporting the results of the studylies) to the Steering Committee and the Monitoring Board. In addition RTI will provide logistic support to the NIMH Program Office and the Steering Committee in arranging meetings of the group, arranging for minutes of the Committee meetings and related staff support functions. These efforts will be carried out in close collaboration with the Steering Committee and the NIMH staff. The proposed data collection and data processing systems are based on a distributed data entry syste involves using well developed data entry, communications and data management software currently being on similar studies by RII staff. Training of Research Group staff to ensure standardization of procedures a sites will also follow well established methods used on several previous multi-site studies. The proposed CC staff have extensive experience in cooperative multi-site studies which the Institu been conducting for over eighteen years and includes a strong interdisciplinary team of biostatisticia psychologist, an epidemiologist, computer systems analysts, a health educator, and a data coordinator.
