NIMH COLLABORATIVE HIV/STD PREVENTION TRIAL

本提案由三角研究所（RTI）提交，作为NIMH合作HIV/STD预防试验的数据协调中心（DCC）。 由T. D博士领导的一支强大的科学家团队。拟定PI Hartwell将提供总体研究协调，包括研究设计、数据管理和统计分析、材料开发、生物标本采集和通用程序培训。 已经召集了经验丰富的统计学家、程序员、人种学家、数据协调员、生物标本、实验室和国际专家来支持试验。 所有这些工作人员在协调多中心研究方面都有丰富的经验。我们建议使用ACASI收集研究的大部分数据。 RTI一直是开发和使用这种数据收集方法的先驱。 我们的通信网络将围绕电子邮件和一个项目网站建立，该网站将用于尽可能传播项目报告和其他信息。我们建议购买试验所需的所有计算机设备，在评估程序和干预措施实施方面协调培训每个国家的研究中心工作人员，协助生物样本采集的跟踪、培训和质量控制，协助协调和分析人种学研究的数据，协助材料开发，分析研究数据并协助手稿准备。此外，RTI将为整个研究提供后勤支持。 这包括建立电话会议和会议，在这些会议上做记录，并分发学习材料（例如，协议、数据表单和操作手册）。 我们还将在每个国家聘请现场数据收集协调员，并将使用分布在世界各地的RTI区域专家协助培训和现场访问。

This proposal is submitted by Research Triangle Institute (RTI) to serve as the Data Coordinating Center (DCC) for the NIMH Collaborative HIV/STD Prevention Trial. A strong team of scientists led by Dr. T.D. Hartwell, the proposed PI, will provide overall study coordination, including study design, data management, and statistical analysis, materials development, biological specimen collection, and training in common procedures. An experienced staff of statisticians, programmers, ethnographers, data coordinators, biological specimen, laboratory, and international specialists have been assembled to support the trial. All of this staff have a great deal of experience in coordinating multicenter studies. We proposed to use ACASI to collect the majority of the data for the study. RTI has been a pioneer in the development and use of this method of data collection. Our communications network will be built around e-mail and a project web site which will be used to disseminate project reports and other information whenever possible. We propose to purchase all of the computer equipment for the trial, to coordinate training site staff in each country in assessment procedures and intervention delivery, to assist in tracking, training, and quality control for biological specimen collection to assist in coordinating and analyzing data for the ethnographic studies, to assist in materials development, to analyze the study data and to assist in manuscript preparation. In addition, RTI will provide logistic support for the entire study. This includes setting up conference calls and meetings, taking minutes at these meetings, and distributing study materials (e.g., protocols, data forms, and manuals of operation). We also will hire on-site data collection coordinators in each country and will use RTI regional specialists who are located throughout the world to assist with training and site visits.