LC: HIV Prevention Trials Network

描述（由申请人提供）：凭借13年的经验和出色的业绩记录，艾滋病毒预防试验网络（HPTN）实验室中心（LC）处于最佳位置，以支持2013年及以后的HPTN。作为HPTN领导小组的一部分，LC将帮助塑造网络的科学议程。HPTN LC将监督研究中心的实验室活动;执行质量控制/质量保证（QA/QC）和HPTN方案的专门检测;评价和验证HPTN方案中使用的检测试剂盒;开发新的检测试剂盒以实现研究目标;并执行与HIV预防相关的辅助研究。HPTN LC拥有全面的QA/QC，病毒学和药理学核心，并在其他关键领域（性传播疾病，微生物学，免疫学和毒理学）提供支持实验室。HPTN LC在支持美国、南美洲、亚洲和非洲的艾滋病毒预防试验方面拥有丰富的经验，并领导了协调网络和其他团体实验室程序的努力。HPTN LC支持HPTN协议，评估艾滋病毒预防的行为，生物医学和结构性干预措施，通常在广泛的环境和非传统场所组合提供。这包括观察性、I期、II期和III期研究，并向未感染艾滋病毒的个人、感染艾滋病毒的个人、夫妇、队列和社区提供干预措施。HPTN研究人群包括青少年、女性、男男性行为者、血清不一致夫妇、注射吸毒者和急性HIV感染者，有些试验招募了> 50，000名参与者。HPTN LC的具体目标是：目标1：为HPTN提供领导、专业知识和实验室支持;目标2：支持现场实验室并确保HPTN实验室结果的质量;目标3：通过检测开发和生物医学研究推进艾滋病毒预防科学。一个强大而有效的LC在HPTN中尤为重要，因为HIV预防试验具有广泛的国际范围、多样性和复杂性。这一奖项将使HPTN能够继续其使命，以确定有效的艾滋病毒预防战略，这将有助于结束艾滋病毒/艾滋病的流行。 相关性：艾滋病毒预防试验网络（HPTN）的目标是确定有效的艾滋病毒预防战略。HPTN实验室中心（LC）是HPTN领导小组的一部分。HPTN LC研究人员将监督在研究中心进行的实验室检测，分析HPTN研究中收集的样本，开发新的实验室检测方法，并进行与HIV预防相关的实验室相关研究。

DESCRIPTION (provided by applicant): With 13 years of experience and an outstanding record of performance, the HIV Prevention Trials Network (HPTN) Laboratory Center (LC) is optimally positioned to support the HPTN in 2013 and beyond. As part of the HPTN Leadership Group, the LC will help shape the network's scientific agenda. The HPTN LC will oversee laboratory activities at study sites; perform Quality Control/Quality Assurance (QA/QC) and specialized testing for HPTN protocols; evaluate and validate assays for use in HPTN protocols; develop novel assays to achieve study objectives; and perform ancillary studies related to HIV prevention. The HPTN LC has comprehensive QA/QC, Virology, and Pharmacology Cores, with Support Laboratories in other key areas (Sexually Transmitted Diseases, Microbiology, Immunology, and Toxicology). The HPTN LC has extensive experience supporting HIV prevention trials in the United States, South America, Asia, and Africa and has led efforts to harmonize laboratory procedures across networks and in other groups. The HPTN LC has supported HPTN protocols evaluating behavioral, biomedical, and structural interventions for HIV prevention, often delivered in combination in a wide range of settings and non-traditional venues. This includes observational, Phase I, Phase II and Phase III studies, with interventions delivered to HIV uninfected individuals, HIV-infected individuals, couples, cohorts, and communities. HPTN study populations include adolescents, women, men who have sex with men, serodiscordant couples, injection drug users, and individuals with acute HIV infection, with some trials enrolling >50,000 participants. The Specific Aims of the HPTN LC are: Aim 1: To provide leadership, expertise, and laboratory support to the HPTN; Aim 2: To support site laboratories and ensure the quality of HPTN laboratory results; Aim 3: To advance HIV prevention science through assay development and biomedical research. A strong and effective LC is particularly important in the HPTN because of the vast international scope, diversity, and complexity of HIV prevention trials. This award will enable the HPTN to continue its mission to identify effective strategies for HIV prevention that will help end the HIV/AIDS epidemic. RELEVANCE: The goal of HIV Prevention Trials Network (HPTN) is to identify effective strategies for HIV prevention. The HPTN Laboratory Center (LC) is part of the HPTN leadership group. HPTN LC investigators will oversee laboratory testing performed at study sites, analyze samples collected in HPTN studies, develop novel laboratory assays, and perform laboratory-related research relevant to HIV prevention.