RTI International (RTI) proposes to serve as the Data Coordinating Center (DCC) for the continuation of the NIHM-sponsored Collaborative HIV/STD Prevention Trial that is underway in five international sites. A strong team of scientists including the proposed PI, Dr. T.D. Hartwell, Co-PIs, Deborah McFadden and Lisa Strader, and faculty from Johns Hopkins (JH) and University of Arizona (AU) will lead the project and will provide overall study coordination, including study design, data collection and management, statistical analysis, materials development, biological specimen collection, training in common procedures, and implementation of quality control procedures. An experienced staff of statisticians, systems analysts and programmers, project managers, biological specimen experts, information technologists, and survey specialists who have been coordinating the trial for the past 4? years are available to continue to support the trial. All of these members have many years of experience in coordinating multicenter studies. We propose to continue to use computer-assisted personal interviews (CAPI) to collect the majority of the behavioral data for the study and to have Johns Hopkins University staff continue to oversee the collection of all biological data in the five sites. Our information technology network, which is based on a local area network (LAN) in each site consisting of a computer server, ethernet switch, a connection to the Internet and desktop and laptop computers, will continue to be used. We propose to continue to upgrade computer equipment as needed at each site, to coordinate training site staff in assessment procedures and intervention delivery, to develop new CAPI programs for the follow-up studies, to assist in tracking, to conduct training and quality control for biological specimen collection including periodic site visits, to assist in materials development, to analyze the study data and to report regularly to the Steering Committee and Data Safety and Monitoring Board on the results of these analyses, and to assist in manuscript preparation. In addition, as in the past, RTI will provide logistic support for the entire Trial. This includes setting up all conference calls and meetings, taking minutes at these meetings, and distributing study materials (e.g., protocols and study manuals) to all U.S. and international sites. We will also visit each international site each year to provide training and quality control.
| NIMH Collaborative HIV/STD Prevention Trial Group (2010) Results of the NIMH collaborative HIV/sexually transmitted disease prevention trial of a community popular opinion leader intervention. J Acquir Immune Defic Syndr 54:204-14 |
