International Collaborative of prospective studies of HIV and Hepatitis in IDU

描述（由申请人提供）：对注射吸毒者（IDU）中HIV和HCV流行谱的了解已经通过在世界各地（包括北美、欧洲和澳大利亚）进行的一些杰出的前瞻性研究而得到推进。每一项研究都进一步加深了我们对疾病流行和发病率、危险行为和自然史（包括临床、免疫和病毒学因素）的理解。该申请为IDU中HIV和HCV前瞻性研究的首次全球合作寻求资助。“注射人群中HIV和HCV事件的国际合作”（InC3）是一个合并的国际多队列项目，汇集了来自9个IDU前瞻性队列的生物学和行为数据。InC3合作将促进对艾滋病毒和丙型肝炎病毒感染进行新的深入研究，这些研究不可能单独进行。这项合作将使我们能够研究4091名IDU患者，他们已经进行了9016人年的观察，859例HCV感染事件和575例HIV感染。该提案包括六个研究问题，这些问题代表了拟议的InC3研究合作的部分（但不是全部）潜在广度和深度，包括：评估HIV和HCV发病率的时间趋势，通过HIV状态和性行为检查HCV发病率，估计HCV病毒清除和再感染的比率和决定因素，检查HCV感染信息对危险行为的影响，以及评估IDU中急性HCV临床治疗的相关结果。由于每项研究中相对较少的行为、病毒或临床事件，许多问题仍未得到解答。然而，由于在这些丰富的纵向队列中，许多人都被细致地描述了特征，合并数据将提供做出坚定结论所需的统计力量。重要和创新的科学议程和InC3领导将得到行政核心和数据协调中心（DCC）的支持。InC3将通过支持参与的青年科学家的研究交流和培训，促进和支持新的研究问题和研究机会的发展。最后，将通过对储存标本的实验室测量的支持来解决生物数据方面的一些空白。这项拟议的InC3研究将完成以下任务：(1)创建丰富的新数据源，填补迄今为止单个研究无法实现的科学知识空白；(2)开展与认识、预防和治疗注射吸毒者中HIV和HCV相关的新研究；(3)建立一个由研究人员和科学家组成的多边合作组织，致力于在流行病学、行为研究、临床研究和实验室科学等领域开展长期合作和伙伴关系。这个拟议的多中心项目的许多调查人员在汇集和分析国家和国际背景下的大型流行病学数据方面经验丰富，并且取得了成功。尽管对公共卫生有明显的好处，但这种有组织的努力从未在同时研究过艾滋病毒和丙型肝炎病毒的队列中进行过尝试。InC3意义重大，具有创新性，将推动与注射吸毒者中艾滋病毒和丙型肝炎病毒感染的全球负担、后果、预防和治疗相关的研究。

DESCRIPTION (provided by applicant): Understanding of the spectrum of the HIV and HCV epidemics in injection drug users (IDU) has been advanced by a number of outstanding prospective studies conducted in various part of the world, including, North America, Europe, and Australia. Each of these studies has furthered our understanding of disease prevalence and incidence, risk behaviors, and natural history, including clinical, immunological and virological factors. This application seeks funding for the first global collaboration of prospective studies of HIV and HCV in IDU. The "International Collaboration of Incident HIV and HCV in Injecting Cohorts" (InC3), is merged international multi-cohort project of pooled biological and behavioral data from nine prospective cohorts of IDU. The InC3 collaboration will facilitate new in-depth studies of HIV and HCV infection not possible from each individual study. This collaboration will allow us to study 4,091 IDU who have been followed for a collective 9,016 person-years of observation, 859 incident HCV infections with longitudinal follow up, and 575 HIV infections. This proposal includes six research questions that represent some, but not all, of the potential breadth and depth of the proposed InC3 research collaboration, including: assessment of temporal trends in HIV and HCV incidence, examination of HCV incidence by HIV status and sexual behavior, estimates of rates and determinants of HCV viral clearance and reinfection, examination of the effects of HCV infection disclosure are on risk behaviors, and an evaluation of outcomes related to clinical treatment of acute HCV in IDU. Many of these questions remain unanswered due to the relatively small number of small numbers of behavioral, viral, or clinical events in each study. However, since many have been meticulously characterized in each of these rich longitudinal cohorts, merging data will offer the statistical power needed to make firm conclusions. The significant and innovative scientific agenda and the InC3 leadership will be supported by an administrative core and Data Coordinating Center (DCC). InC3 will promote and support the development of new study questions and research opportunities through supporting research exchange and training for participating junior scientists. Lastly, some gaps in biological data will be addressed with support for laboratory measures from stored specimens. This proposed InC3 study, will accomplish the following: (1) creation of a rich new data source that will fill scientific knowledge gaps that heretofore have not been possible in single studies alone; (2) enable new research relevant to understanding, preventing, and treating HIV and HCV in IDU; (3) the creation of a multilateral collaborative of researchers and scientists committed to long term cooperation and partnership in areas including: epidemiology, behavioral studies, clinical research, and laboratory science. Many of the investigators of this proposed multicenter project are experienced and successful in pooling and analyzing large epidemiological data in both a national, and international, context. Despite the obvious benefits to public health, such an organized effort has never been attempted with cohorts that have studied both HIV and HCV. InC3 is significant, innovative, will advance research relevant to the global burden, consequences, prevention, and treatment of HIV and HCV infections among IDU.