The specific aim of the applicant is to serve as the Data and Operations Center (DOC) for the Adolescent Medicine Trials Network for HIV/AIDS Intervention (ATN). The primary focus of the ATN will be evaluation of behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected adolescents and adolescents at risk for acquiring HIV. As the DOC, Westat aims to work collaboratively with the ATN clinical sites, leadership groups, and the National Institute of Child Health and Human Development (NICHD) program staff, as well as other HIV research networks to develop and conduct studies that are responsive to the scientific agenda. Westat will: (1) maintain the ATN protocol disbursement fund and execute all necessary agreements with sites to support study and subject accrual costs reconciling reimbursement to site performance with NICHD approval;(2) collaboratively plan and conduct all Adolescent Medicine Leadership Group (AMLG) and ATN meetings;(3) provide methodologic and analytic support to the development of independent research projects, design the corresponding data collection forms and database(s), maintain the database(s) and supply the required analytic capacity;(4) supervise all data collection procedures;(5) provide for the most efficient transfer of study data generated by collaborative research;(6) conduct protocol and site registration and other regulatory duties;(7) establish and support Data and Safety Monitoring Boards (DSMB);(8) provide training to all site personnel related to acceptable quality control and quality assurance procedures;(9) provide on-site monitoring;(10) recruit and support the Community Advisory Board (CAB) staff person and provide logistical support to any CAB-associated meetings if requested by NICHD;(11) participate in regular conference calls and attend AMLG meetings;and (12) provide the NICHD an itemized account of all internal expenditures associated with operational, data management, analytic and other supportive activities. Additional tasks related to the management of a specimen repository, drug management, reporting of site performance, and Serious Adverse Event (SAE) reporting will also be performed if requested by NICHD.
Our goal is to provide the appropriate technical expertise and resources to efficiently design, implement, and manage a broad portfolio of therapeutic, behavioral and community studies. Information obtained from these studies will ultimately be used to develop programs and policies for reducing the incidence of new HIV infections, and for improving methods for addressing clinical, behavioral, and social issues faced by HIV- infected adolescents.
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