Observational Antiretroviral Studies In Southern Africa (OASIS) Collaboration

描述（由申请人提供）：理由：南非是世界上约4000万艾滋病毒感染者中近30%生活的地方，该地区估计占全球人口的2%。虽然该区域估计有200万男子、妇女和儿童迫切需要抗逆转录病毒治疗，但世界卫生组织认为目前有近20万人正在接受治疗。迫切需要回答有关最有效地实施和监测大规模抗逆转录病毒治疗的临床和业务研究问题。具体目标：1)衡量南部非洲抗逆转录病毒治疗的有效性，并描述影响结果的因素；2)通过及时和有效的区域流行病学评估，改善南部非洲有资格接受或开始高效抗逆转录病毒治疗的艾滋病毒和艾滋病患者的预后；3)通过提高在个人和人群层面监测暴露和结果的能力，提高在该地区提供抗逆转录病毒治疗的能力。研究目标：1)描述与向南部非洲儿童和成人提供卫生保健有关的问题，重点关注抗逆转录病毒治疗的提供、等待时间和方案水平对生存和其他结果的影响，包括随访损失；2)描述成人（包括孕妇）和儿童的抗逆转录病毒治疗问题，重点是监测治疗反应和预后因素，包括接触药物以防止母婴传播艾滋病毒，以及与抗逆转录病毒治疗相关的不良事件；3)描述与艾滋病毒感染和抗逆转录病毒治疗使用的重要并发症相关的问题，重点是结核病，免疫重建和炎症综合征，以及预防危及生命的机会性感染。研究设计和方法：OASIS合作包括该地区6个国家的17家诊所和临床队列，涉及35,070名感染艾滋病毒-1的成人和儿童。我们将使用创新和最先进的统计方法来分析这项观察性队列研究的数据，包括考虑数据纵向和分层结构的技术。提出了一种强调长期协作和能力建设的协作方式的业务结构。

DESCRIPTION (provided by applicant): Rationale: Southern Africa is where almost 30% of the approximately 40 million HIV-infected people in the world live, in an area estimated to have 2% of the global population. While an estimated two million men, women, and children are yet in urgent need of antiretroviral treatment in this region, close to 200,000 individuals are now believed by the World Health Organization to be receiving treatment. Answers are urgently needed to clinical and operational research questions regarding the most effective implementation and monitoring of wide-scale antiretroviral treatment delivery. Specific Aims: 1) To measure the effectiveness of antiretroviral therapy in southern Africa, and to describe factors that influence outcomes; 2) To improve the prognosis of people living with HIV and AIDS eligible for or initiating highly active antiretroviral treatment in southern Africa through timely and operative regional epidemiological evaluations; and 3) To increase the capacity for delivering antiretroviral therapy in this region by increasing the capacity for monitoring exposures and outcomes at the individual and population levels. Research Objectives: 1) To describe issues related to the provision of health care to children and adults in southern Africa, with a focus on the delivery of ART, waiting times and program level influences on survival and other outcomes, including losses to follow up; 2) To describe antiretroviral treatment issues in adults (including pregnant women) and children, with an emphasis on the monitoring of treatment response and prognostic factors, including exposure to drugs to prevent mother to child transmission of HIV, and adverse events associated with antiretroviral treatment; and 3) To describe issues related to important complications of HIV infection and antiretroviral therapy use, with a focus on tuberculosis, the immune reconstitution and inflammatory syndrome, and prophylaxis against life-threatening opportunistic infections. Research Design and Methods: The OASIS Collaboration includes 17 clinics and clinical cohorts in 6 countries in the region, involving 35,070 HIV-1 infected adults and children. We will use innovative and state-of-the-art statistical approaches to analyze data from this observational cohort study, including techniques which account for the longitudinal and hierarchical structure of the data. An operational structure is proposed that emphasizes the long-term collaborative and capacity-building approach of the collaboration.