St. Jude-Memphis Adolescent Trials Unit

描述(由申请人提供)：美国青少年和青壮年人口中艾滋病毒/艾滋病发病率的上升令人震惊。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，其南部的地理位置和庞大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有全面医疗服务、有同情心和有兴趣的工作人员、病例管理服务、友好的诊所环境以及对杂费的支持的场所。圣犹大儿童研究医院(SJCRH)是一家大型研究中心，自1988年以来一直为感染艾滋病毒的婴儿、儿童、青少年和孕妇提供全面护理，在青少年人群中表现出卓越的临床试验表现。我们建议在田纳西大学(UT)/卫理公会LeBonheur Health Systems(MLHS)设立另一个实习地点。MLHS是德克萨斯大学普通青少年诊所和Mayah，社区Ryan White，标题四，青年服务计划的网站。这个备用站点将配备圣裘德ATN人员，并在识别、招募和进行艾滋病毒高危但未感染青少年试验方面对主要研究单位表示赞扬。这一模式涉及许多社区教育、推广和测试设施，这些设施将是实施社区地图绘制和疫苗准备研究的关键。这个项目的具体目标是：1)建立一个有效的青少年临床试验股，通过招募和保留感染艾滋病毒和未感染艾滋病毒的高危青少年参加生物医学和行为临床试验，推动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，以有效地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式；以及3)通过调查人员和现场人员参与制定方案概念表和方案，促进青少年试验网络的科学议程。孟菲斯的ATU将提供成熟的、多产的临床研究中心和邻近大量高危人群的组合优势，以最大限度地实现青少年人口中的研究努力。

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.