Observational Antiretroviral Studies In Southern Africa (OASIS) Collaboration

理由：南部非洲约4 000万艾滋病毒感染者中有近30%在南部非洲， 据估计，这个地区的人口占全球人口的2%。估计有200万人， 该地区近20万妇女和儿童仍迫切需要抗逆转录病毒治疗 世界卫生组织现在认为有个人正在接受治疗。答案 迫切需要临床和业务研究的问题，关于最有效的实施 和监测大规模提供抗逆转录病毒治疗。 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感染者和艾滋病患者的预后 或在南部非洲通过及时有效的区域和区域方案， 流行病学评价; 3）提高该区域提供抗逆转录病毒疗法的能力 通过提高监测个人和人口一级的照射和结果的能力。 研究目的：1）描述与向儿童和成人提供卫生保健有关的问题， 南部非洲，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率的影响 和其他结果，包括失访; 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， 预后因素，包括接触预防母婴传播艾滋病毒的药物， 与抗逆转录病毒治疗相关的事件;和3）描述与重要并发症相关的问题 艾滋病毒感染和抗逆转录病毒疗法的使用，重点是结核病、免疫重建和 炎性综合征和预防危及生命的机会性感染。 研究设计和方法：OASIS协作包括6个国家的17个诊所和临床队列 在该地区的一些国家，涉及35 070名艾滋病毒1型感染的成人和儿童。我们将采用创新和 分析这项观察性队列研究数据的最新统计方法，包括 说明数据的纵向和层次结构的技术。一个业务机构 提出了一个强调长期协作和能力建设的协作方法。

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.