St. Jude-Memphis Adolescent Trials Unit

圣裘德-孟菲斯青少年试验中心

• 批准号: 7050919
• 负责人: PATRICIA MICHELE FLYNN
• 金额: $ 40.33万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-03 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7050919
• 关键词: AIDS; AIDS /HIV diagnosis; AIDS education /prevention; HIV infections; adolescence (12-20); antiAIDS agent; behavioral /social science research tag; clinical research; clinical trials; community; cooperative study; experimental designs; health science research analysis /evaluation; high risk behavior /lifestyle; human immunodeficiency virus 1; human subject; young adult human (21-34)

DESCRIPTION (provided by applicant): The rising incidence of HIV/AIDS in the adolescent and young adult population in the United States is alarming. It is now estimated that 25% - 50 % of new cases in the U.S. are occurring in youth. Memphis and the surrounding area are no exception and its Southern location and large minority population has also impacted the rapid increase in cases. The successful conduct of clinical trials in adolescents requires a site with comprehensive medical services, compassionate and interested staff, case management services, a friendly clinic environment, and support for incidentals. St. Jude Children's Research Hospital (SJCRH) is a large research center that has provided comprehensive care for HIV-infected infants, children, adolescents, and pregnant women since 1988 with demonstrated excellence in clinical trials performance in the adolescent population. We propose an alternate practice site at the University of Tennessee (UT)/Methodist LeBonheur Health Systems (MLHS). MLHS is the site for UT's General Adolescent Clinics and MAYAH, the community Ryan White, Title IV, Youth Services Program. This alternate site will be staffed by St. Jude ATN personnel and compliment the main research unit in the identification, recruitment, and conduct of trials in HIV-at risk but uninfected adolescents. This model engages many community education, outreach, and testing facilities that will be key in implementing community mapping and vaccine preparedness studies. The specific aims of this project are: 1) To establish an effective adolescent clinical trials unit to further the scientific agenda of the Adolescent Trials Network through the recruitment and retention of HIV-infected and at-risk HIV-uninfected pre-adolescents, adolescents, and young adults into biomedical and behavioral clinical trials; 2) To further develop existing community linkages to effectively establish a community-based primary prevention infrastructure that will support clinical trials of HIV prevention efforts, including vaccines, and other biomedical modalities; and 3) To contribute to the scientific agenda of the Adolescent Trials Network through the participation of investigators and site personnel in the development of protocol concept sheets and protocols. An ATU in Memphis would offer the combined advantages of an established, productive clinical research center with the proximity of a large at-risk population to maximize realization of the research efforts in the adolescent population.

描述（由申请人提供）：美国青少年和年轻人人口的艾滋病毒/艾滋病发病率上升令人震惊。现在据估计，在美国，有25％ - 50％的新病例发生在青年中。孟菲斯及周边地区也不例外，其南部地点和少数族裔人口也影响了案件的迅速增加。在青少年进行临床试验的成功进行，需要一个拥有全面的医疗服务，富有同情心和感兴趣的员工，案例管理服务，友好的诊所环境以及对杂项的支持。自1988年以来，圣裘德儿童研究医院（SJCRH）是一个大型研究中心，为感染了艾滋病毒的婴儿，儿童，青少年和孕妇提供了综合护理，在青少年人群的临床试验表现方面表现出色。我们建议在田纳西大学（UT）/卫理公会莱邦海尔卫生系统（MLHS）的替代实践地点。 MLHS是UT的一般青少年诊所和Mayah，社区Ryan White，Title IV，青年服务计划的网站。该替代地点将由圣裘德ATN人员组成，并赞美主要研究部门，以识别，招募和进行HIV-AT风险试验但未感染的青少年进行试验。该模型参与了许多社区教育，外展和测试设施，这将是实施社区制图和疫苗准备研究的关键。该项目的具体目的是：1）建立一个有效的青少年临床试验单元，通过招募和保留HIV感染的HIV感染和处于艾滋病毒的HIV未感染的预种植前，青少年，青少年以及年轻人进入生物学和行为临床临床临床试验中，以进一步进一步促进青少年试验网络的科学议程； 2）进一步建立现有的社区联系，有效建立基于社区的初级预防基础设施，该基础设施将支持艾滋病毒预防工作的临床试验，包括疫苗和其他生物医学模式； 3）通过调查人员和现场人员参与协议概念表和协议的开发，为青少年试验网络的科学议程做出贡献。孟菲斯的一个ATU将提供一个既定的，生产性临床研究中心的联合优势，并具有庞大的高危人群的距离，以最大程度地实现青少年人口的研究工作。