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.
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