St. Jude-Memphis Adolescent Trials Unit

描述（由申请人提供）：美国青少年和年轻成人中艾滋病毒/艾滋病发病率的上升令人担忧。据估计，美国25% - 50%的新病例发生在年轻人身上。孟菲斯及其周边地区也不例外，其南部位置和大量少数民族人口也影响了病例的迅速增加。要在青少年中成功地开展临床试验，需要有全面的医疗服务、富有同情心和兴趣的工作人员、病例管理服务、友好的诊所环境以及对意外事件的支持。圣犹达儿童研究医院（SJCRH）是一家大型研究中心，自1988年以来为感染艾滋病毒的婴儿、儿童、青少年和孕妇提供全面护理，在青少年人群的临床试验中表现出色。我们建议在田纳西大学(UT)/卫理公会LeBonheur卫生系统（MLHS）的备选实践地点。MLHS是德州大学普通青少年诊所和MAYAH的网站，社区瑞安·怀特，标题四，青年服务计划。这一备选地点将由圣犹达ATN的工作人员担任，并补充主要研究单位在艾滋病毒风险但未感染的青少年中进行识别、招募和试验。这一模式涉及许多社区教育、外联和测试设施，这将是实施社区测绘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，通过招募和留住感染艾滋病毒和有可能感染艾滋病毒的前青少年、青少年和年轻人参加生物医学和行为临床试验，进一步推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，包括疫苗和其他生物医学方法；3)通过研究人员和现场人员参与方案概念表和方案的制定，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，并接近大量的高危人群，以最大限度地实现对青少年人群的研究努力。

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.