NIMH Collaborative HIV/STD Prevention Trial

RTI国际（RTI）建议作为数据协调中心（DCC），继续在五个国际研究中心进行由NIH赞助的艾滋病毒/性病预防合作试验。一个强大的科学家团队，包括拟议的PI，T. D博士。Hartwell、Co-PI、Deborah McFadden和丽莎Strader以及来自约翰霍普金斯（JH）和亚利桑那大学（Au）的教师将领导该项目，并将提供总体研究协调，包括研究设计、数据收集和管理、统计分析、材料开发、生物标本收集、通用程序培训和质量控制程序的实施。由经验丰富的统计员、系统分析员和 程序员，项目经理，生物标本专家，信息技术专家，以及在过去4年中一直协调试验的调查专家？可以继续支持审判。所有这些成员在协调多中心研究方面都有多年的经验。我们建议继续使用计算机辅助个人访谈（CAPI）来收集研究的大部分行为数据，并让约翰霍普金斯大学的工作人员继续监督五个研究中心所有生物数据的收集。我们的信息技术网络将继续使用，该网络以每个地点的局域网为基础，包括一台计算机服务器、以太网交换机、与因特网的连接以及台式和膝上型计算机。我们建议继续根据需要升级每个研究中心的计算机设备，协调培训研究中心工作人员进行评估程序和干预措施的实施，为随访研究开发新的CAPI程序，协助跟踪，进行生物样本采集的培训和质量控制，包括定期研究中心访视，协助材料开发，分析研究数据并报告 定期向指导委员会和数据安全和监测委员会报告这些分析的结果，并协助撰写论文。此外，与过去一样，RTI将为整个试验提供后勤支持。这包括建立所有电话会议和会议，在这些会议上做记录，并分发学习材料（例如，方案和研究手册）提供给所有美国和国际研究中心。我们还将每年访问每个国际站点，以提供培训和质量控制。

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.