International Collaborative of prospective studies of HIV and Hepatitis in IDU

描述（由申请人提供）：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，加深了对注射吸毒者（IDU）中HIV和HCV流行谱的了解。这些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、免疫学和病毒学因素）的理解。该申请旨在为首次在注射吸毒者中开展艾滋病毒和丙型肝炎病毒前瞻性研究的全球合作提供资金。“注射队列中HIV和HCV事件的国际合作”（InC 3）是来自9个注射吸毒者前瞻性队列的汇总生物学和行为数据的合并国际多队列项目。InC 3的合作将促进对HIV和HCV感染的新的深入研究，而这些研究不可能来自每一项单独的研究。这项合作将使我们能够研究4，091名接受了9，016人-年观察的注射吸毒者，859例纵向随访的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InC 3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病毒清除率和再感染的决定因素，检查HCV感染披露对风险行为的影响，以及对静脉吸毒者中急性HCV临床治疗相关结局的评价。由于每项研究中的行为、病毒或临床事件数量相对较少，这些问题中的许多仍然没有答案。然而，由于这些丰富的纵向队列中有许多已经被仔细描述，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InC 3的领导将得到行政核心和数据协调中心（DCC）的支持。InC 3将通过支持研究交流和培训参与的年轻科学家来促进和支持新的研究问题和研究机会的开发。最后，生物数据方面的一些差距将通过支持从储存的标本中采取实验室措施来解决。这项拟议的InC 3研究将实现以下目标：（1）创建一个丰富的新数据源，填补迄今为止单靠单一研究无法填补的科学知识空白;（2）实现与理解、预防和治疗注射吸毒者中的HIV和HCV相关的新研究;（3）建立一个由致力于长期合作和伙伴关系的研究人员和科学家组成的多边协作机构，包括：流行病学、行为研究、临床研究和实验室科学。这项多中心项目的许多研究者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研究HIV和HCV的队列中尝试过。InC 3是重要的，创新的，将推进与全球负担，后果，预防和治疗注射吸毒者中的HIV和HCV感染相关的研究。 公共卫生相关性：此次国际合作：InC 3将创建一个合并的国际多队列项目，该项目的数据来自22年来在4个国家进行的9项注射吸毒前瞻性研究。该合作将产生最大的数据集，用于分析和研究注射吸毒者中的艾滋病毒和HCV感染，包括急性HCV感染和艾滋病毒/HCV合并感染。结合的专业知识和研究数据将推进与注射吸毒者中艾滋病毒和HCV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. PUBLIC HEALTH RELEVANCE: This international collaboration: the InC3, will create a merged international multi-cohort project of data pooled from nine prospective studies of IDU conducted in four countries over 22 years. The collaboration will result in the largest dataset available for analyses and research on HIV and HCV infections in IDU, including acute HCV infection and HIV/HCV co-infections. The combined expertise and research data will advance research relevant to the global burden, consequences, prevention, and treatment of HIV and HCV infections among IDU.