Observational Antiretroviral Studies In Southern Africa (OASIS) Collaboration

理由：南部非洲是世界上约4000万艾滋病毒感染者中近30%的地方 据估计，这个地区的人口占全球人口的2%。而据估计有200万男性， 该地区的妇女和儿童仍迫切需要抗逆转录病毒治疗，近20万人。 世界卫生组织现在认为，这些人正在接受治疗。答案是 迫切需要对临床和运营研究提出关于最有效实施的问题 以及监测大规模抗逆转录病毒治疗的提供情况。 具体目标：1)衡量南部非洲抗逆转录病毒疗法的有效性，并描述 影响结果的因素；2)改善符合条件的艾滋病毒/艾滋病感染者的预后 或通过及时和有效的区域行动在南部非洲启动高效抗逆转录病毒治疗 流行病学评估；以及3)提高该地区提供抗逆转录病毒治疗的能力 通过提高监测个人和人口层面的暴露情况和结果的能力。 研究目标：1)描述与#年向儿童和成人提供保健有关的问题 南部非洲，重点是ART的交付、等待时间和计划水平对生存的影响 和其他结果，包括失去随访；2)描述成人抗逆转录病毒治疗问题 (包括孕妇)和儿童，重点是监测治疗反应和 预后因素，包括接触预防母婴传播艾滋病毒的药物，以及不良反应 与抗逆转录病毒治疗相关的事件；以及3)描述与重要并发症有关的问题 艾滋病毒感染和抗逆转录病毒治疗的使用，重点是结核病、免疫重建和 炎症综合症，以及对危及生命的机会性感染的预防。 研究设计和方法：绿洲合作包括6个项目中的17个诊所和临床队列 该区域各国共涉及35,070名感染艾滋病毒-1的成人和儿童。我们将用创新和 分析这项观察性队列研究数据的最先进的统计方法，包括 说明数据的纵向和层次结构的技术。运营架构 强调合作的长期协作和能力建设办法。

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.