St. Jude-Memphis Adolescent Trials Unit

描述（由申请人提供）：美国青少年和年轻成人人口中艾滋病毒/艾滋病的发病率上升令人担忧。据估计，美国25% -50%的新病例发生在年轻人中。孟菲斯及其周边地区也不例外，其南部的位置和大量的少数民族人口也影响了病例的快速增加。在青少年中成功进行临床试验需要一个具有全面医疗服务、富有同情心和感兴趣的工作人员、病例管理服务、友好的诊所环境和对杂费的支持的研究中心。圣裘德儿童研究医院（SJCRH）是一家大型研究中心，自1988年以来为艾滋病毒感染的婴儿、儿童、青少年和孕妇提供全面护理，在青少年人群中的临床试验表现卓越。我们建议在田纳西大学（UT）/卫理公会LeBonheur卫生系统（MLHS）的替代实践网站。MLHS是UT的一般青少年诊所和MAYAH，社区瑞安白色，标题四，青年服务计划的网站。该备用中心将由St. Jude ATN人员组成，并在艾滋病毒高危但未感染青少年的识别、招募和试验实施方面对主要研究单位进行补充。这一模式涉及许多社区教育、外展和测试设施，这些设施将是实施社区绘图和疫苗准备研究的关键。该项目的具体目标是：1）建立一个有效的青少年临床试验单位，通过招募和保留感染艾滋病毒和未感染艾滋病毒的青少年前、青少年和年轻人参加生物医学和行为临床试验，促进青少年试验网络的科学议程;（2）进一步发展现有的社区联系，以有效建立以社区为基础的初级预防基础设施，支持艾滋病毒预防工作的临床试验，包括疫苗，以及其他生物医学模式;以及3）通过研究人员和研究中心工作人员参与制定方案概念说明书和方案，为青少年试验网络的科学议程做出贡献。孟菲斯的ATU将提供一个成熟的、富有成效的临床研究中心的综合优势，同时靠近大量的高危人群，以最大限度地实现青少年人群中的研究工作。

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.