Measuring Incident Human Immonodeficiency Virus (HIV-1) Infections in China

描述（申请人提供）：中国有13亿人口，占世界人口的20%。1型人体免疫缺陷病毒（HIV-1）的感染率即使稍有增加，也会导致感染者的绝对人数大幅增加。虽然从血清流行率数据可以清楚地看出，艾滋病毒正在从高危人群向普通人群传播，但中国卫生当局没有有效的措施控制艾滋病毒的发病率。艾滋病毒流行情况很好地说明了这一流行病的历史，但没有突出最近的趋势或“热点”。艾滋病毒发病率监测（HIS）需要用于区分近期和长期的艾滋病毒感染，确定高危人群的感染模式，促进对艾滋病毒传播动态的时间敏感评估，查明疫情，并衡量预防方案的有效性。我们提出的研究的目的是验证一种新的血清学方法-免疫球蛋白G (IgG)-捕获B， E和D型（“BED”）-酶免疫测定（BED- ceia）来识别最近的HIV-1血清转化-以测量中国的HIV发病率。我们将评估开发基于血清学的HIS的有效性和可行性，为公共卫生干预、资源分配和项目评估提供更准确的信息。该项目的具体目标是：1)。通过研究前瞻性队列中中国参与者血清转化前和血清转化后标本，评估BED - ceia测量HIV-1发病率的有效性。这个R03奖的第一年是为具体目标1服务的。2）. 要么（选项1）开始开发一个中国特有的BED-CEIA，要么（选项2）使用经过验证的BED-CEIA计划一个试点HIS项目。选择1还是选择2将取决于具体目标1的结果。这个R03奖的第二年将按照科学规定，追求选项1或2。

DESCRIPTION (provided by applicant): China has 1.3 billion people, accounting for 20% of the world's population. Even a slight increase in the infection rate of human immunodeficiency virus type 1 (HIV-1) would result in a substantial increase in the absolute number of infected persons. While it is clear from seroprevalence data that HIV is spreading from high risk groups to the general population, Chinese health authorities have no effective measures for HIV incidence. HIV prevalence provides a good picture of the history of the epidemic, but does not highlight recent trends or "hotspots". HIV incidence surveillance (HIS) is needed to distinguish between recent and long-term HIV infection, to determinate patterns of infection in high-risk populations, to facilitate time-sensitive evaluation of HIV transmission dynamics, to pinpoint outbreaks, and to measure the effectiveness of prevention programs. The objective of our proposed study is to validate a novel serologic method--- an immunoglobulin G (IgG)- capture types B, E, and D ("BED")-enzyme immunoassay (BED-CEIA) to identify recent HIV-1 seroconversion --- to measure HIV incidence in China. We will assess the validity and feasibility of developing a serology based HIS to provide more accurate information for public health intervention, resource distribution, and program evaluation. The Specific Aims of This Project are: 1). To assess the validity of the BED -CEIA for measuring HIV-1 incidence by studying well-characterized pre- and post-seroconversion specimens from Chinese participants in prospective cohorts. Year one of this R03 award is in the service of Specific Aim 1. 2). Either (OPTION 1) to begin the process of developing a China-specific BED-CEIA, or (OPTION 2) to plan a pilot HIS project using the validated BED-CEIA. Whether we pursue option 1 or 2 will depend upon the results of Specific Aim 1. Year two of this R03 award will be in the pursuit of option 1 or 2, as the science dictates.