St. Jude-Memphis Adolescent Trials Unit

圣裘德-孟菲斯青少年试验中心

基本信息

批准号：
7585726
负责人：
PATRICIA MICHELE FLYNN
金额：
$ 48.37万
依托单位：
ST. JUDE CHILDREN'S RESEARCH HOSPITAL
依托单位国家：
美国
项目类别：
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/7585726
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Adolescent Adolescent Medicine Adolescent Medicine Trials Network Adult Area Case Management Case Study Child Clinic Clinical Research Clinical Trials Clinical Trials Unit Communities Community Health Education Comprehensive Health Care Conduct Clinical Trials Education and Outreach Environment HIV HIV Infections Health Health system Human Resources Incidence Infant Life Location Maps Medical Methodist Church Minority Modality Modeling Performance Perinatal Persons Population Populations at Risk Pregnant Women Primary Prevention Protocols documentation Readiness Research Research Infrastructure Research Personnel Risk Saint Jude Children&apos s Research Hospital Services Site Tennessee Testing United States Universities Vaccines Youth age group aged base behavioral clinical trial experience improved interest programs protocol development transmission process urban area young adult

项目摘要

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.

美国青少年和年轻成年人口中艾滋病毒/艾滋病的发病率不断上升令人震惊。据估计，美国 25% - 50% 的新病例发生在青少年中。孟菲斯和周边地区也不例外，其南部位置和大量少数民族人口也影响了病例的快速增加。在青少年中成功进行临床试验需要一个场所提供全面的医疗服务、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杂费支持。圣裘德儿童研究医院 (SJCRH) 是一家大型研究中心，为感染艾滋病毒的婴儿、儿童、青少年提供全面护理，自 1988 年以来，在临床试验中表现出色青少年人口。我们建议在田纳西大学 (UT)/卫理公会大学建立一个替代练习地点 LeBonheur 卫生系统 (MLHS)。 MLHS 是 UT 普通青少年诊所和 MAYAH（社区 Ryan White，第四章，青年服务计划。该备用站点将由 St. Jude ATN 负责工作人员并赞扬主要研究单位在确定、招募和进行试验方面的工作有艾滋病毒风险但未感染的青少年。该模式涉及许多社区教育、外展和测试设施对于实施社区绘图和疫苗准备研究至关重要。这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，以进一步促进通过招募和保留艾滋病毒感染者和青少年试验网络的科学议程未感染艾滋病毒的高危青少年、青少年和年轻人进入生物医学和行为临床试验； 2) 进一步发展现有的社区联系，有效建立以社区为基础的小学预防基础设施，支持艾滋病毒预防工作的临床试验，包括疫苗，以及其他生物医学方式； 3) 为青少年试验网络的科学议程做出贡献通过调查人员和现场人员参与方案概念表的制定和协议。孟菲斯的 ATU 将提供成熟、高效的综合优势临床研究中心靠近大量高危人群，以最大限度地实现研究青少年群体中的努力。