International Collaborative of prospective studies of HIV and Hepatitis in IDU

描述(由申请人提供)：在包括北美、欧洲和澳大利亚在内的世界各地进行的一些杰出的前瞻性研究促进了对注射吸毒者(IDU)中艾滋病毒和丙型肝炎流行病谱的了解。这些研究中的每一项都加深了我们对疾病流行和发病率、危险行为和自然病史的理解，包括临床、免疫学和病毒学因素。这项申请寻求为注射吸毒者艾滋病毒和丙型肝炎前瞻性研究的第一次全球合作提供资金。“国际艾滋病和丙型肝炎病毒注射队列协作”(INC3)是一个合并的国际多队列项目，汇集了注射吸毒者9个预期队列的生物和行为数据。InC3的合作将促进对艾滋病毒和丙型肝炎病毒感染的新的深入研究，这是每项单独研究都不可能实现的。这项合作将使我们能够研究4091名吸毒者，他们被跟踪了9016人年的集体观察，859例丙型肝炎病毒感染病例和575例艾滋病毒感染病例。这项建议包括六个研究问题，它们代表了拟议的InC3研究合作的部分但不是全部的潜在广度和深度，包括：评估艾滋病毒和丙型肝炎病毒发病率的时间趋势，按艾滋病毒状况和性行为检查丙型肝炎病毒发病率，估计丙型肝炎病毒清除和再感染的比率和决定因素，检查丙型肝炎病毒感染披露对危险行为的影响，以及评估与静脉注射治疗中急性丙型肝炎临床治疗相关的结果。由于每项研究中行为、病毒或临床事件的数量相对较少，这些问题中的许多仍然没有得到回答。然而，由于这些丰富的纵向队列中的每一个都对许多人进行了仔细的描述，合并数据将提供做出确定结论所需的统计力量。重大和创新的科学议程和INC3的领导将得到一个行政核心和数据协调中心(DCC)的支持。INC3将通过支持参与的初级科学家的研究交流和培训，促进和支持新研究问题和研究机会的开发。最后，将通过对储存标本的实验室措施的支持来解决生物数据中的一些差距。这项拟议的INC3研究将实现以下目标：(1)创建丰富的新数据来源，填补迄今仅靠单一研究无法填补的科学知识空白；(2)使与了解、预防和治疗注射用药中的艾滋病毒和丙型肝炎病毒有关的新研究成为可能；(3)创建致力于在流行病学、行为研究、临床研究和实验室科学等领域进行长期合作与伙伴关系的研究人员和科学家的多边协作机制。这个拟议的多中心项目的许多研究人员在汇集和分析国家和国际背景下的大量流行病学数据方面经验丰富并取得成功。尽管这对公众健康有明显的好处，但这种有组织的努力从未在同时研究艾滋病毒和丙型肝炎的队列中尝试过。InC3具有重大的创新性，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.