Adolescent Trials Network for HIV/AIDS Intervention

此应用程序是对RFA HD-00-002，青少年医学艾滋病毒/艾滋病干预试验网络(ATN)的响应。申请者的具体目标是作为ATN的数据和运营中心(DOC)。ATN将包括一个青少年医学领导小组(AMLG)和18-20个青少年医学试验单位(AMTU)。ATN的主要重点将是评估艾滋病毒感染青少年和有感染艾滋病毒风险的青少年的行为、杀微生物剂、预防性、治疗性和疫苗方式。大多数干预措施将与其他艾滋病毒研究网络合作进行，但ATN将设计和进行一些与青少年特有问题有关的独立研究。作为DOC，我们的目标是与AMLG、AMTU、NICHD项目工作人员和执行委员会合作，以及在ATN内联网进行研究的其他艾滋病毒研究。具体地说，我们将1)协作计划和举行AMLG和ATN会议，包括提供后勤支持服务；2)与AMLG就管理数据库设计和监测问题进行互动；3)开发和维护管理数据库；4)为项目和开发数据提供方法论支持；5)为研究设计、方案制定、数据监测、数据分析和手稿准备提供统计和分析资源；6)编写统计和其他报告，供NICHD项目工作人员、数据安全和监测委员会(DSMB)和执行委员会使用；7)开发和维护ATN研究数据库；8)开发和实施研究项目；9)协调有效的数据采集并将其传输到其他研究网络，用于协作项目；10)处理合作研究的监管要求；11)监督ATMU的数据收集程序；12)提供研究手册，并培训AMTU工作人员进行协议执行和质量保证；13)定期对AMTU进行现场监测；14)支持社区咨询委员会(CAB)工作人员，并为CAB会议提供后勤支持；15)参加AMLG的定期电话会议和会议；16)维护ATN参与者的电子邮件系统。

This application is in response to RFA HD-00-002, adolescent Medicine Trials Network for HIV/AIDS Intervention (ATN). The specific aim of the applicant is to serve as the Data and Operations Center (DOC) for the ATN. The ATN will include an Adolescent Medicine Leadership Group (AMLG) and 18-20 Adolescent Medicine Trial Units ( AMTUs). The primary focus of the ATN will be evaluation of behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected adolescents and adolescents at risks for acquiring HIV. Most intervention will be done in collaboration with other HIV research networks but the ATN will design and conduct some independent research related to issues that are unique in adolescents. As the DOC, we aim to work collaboratively with the AMLG, the AMTUs, the NICHD program staff, and the Executive Committee, and other HIV research networked to perform research within the ATN Specifically, we will 1) collaboratively plan and conduct AMLG and ATN meetings, including providing logistical support services; 2) interact with the AMLG on managerial database design and monitoring issues; 3) develop and maintain the managerial database; 4) provide methodologic support for project and data from development; 5) provide statistical and analytical resources for study design, protocol development, data monitoring, data analysis, and preparation of manuscripts; 6) prepare statistical and other reports for use by NICHD program staff, the Data Safety and Monitoring Board (DSMB), and Executive Committee; 7) develop and maintain ATN study databases; 8) develop and implement research projects; 9) coordinate efficient data capture and transfer to other research networks for collaborative projects; 10) handle regulatory requirements for collaborative research; 11) supervise data collection procedures at the ATMUs; 12) provide study manuals and train AMTU staff in protocol implementation and quality assurance; 13) perform periodic site monitoring of AMTUs; 14) support a Community Advisory Board (CAB) staff member and provide logistical support for CAB meetings; 15) participate in regular conference calls and meetings off the AMLG; and 16) maintain an electronic E-mail system for ATN participants.