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%。即使1型人体免疫机能丧失病毒（HIV-1）感染率略有增加，感染者的绝对人数也会大幅度增加。虽然从血清阳性率数据中可以清楚地看出，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来控制艾滋病毒的发病率。艾滋病毒流行率很好地反映了这一流行病的历史，但没有突出显示最近的趋势或“热点”。艾滋病毒发病率监测（HIS）是必要的，以区分最近和长期的艾滋病毒感染，以确定在高危人群中的感染模式，以促进对艾滋病毒传播动态的时间敏感的评价，以查明疫情，并衡量预防计划的有效性。本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”）-酶免疫测定法（BED-CEIA），以确定最近的HIV-1血清转换-来测量中国的HIV发病率。我们将评估发展一个以血清学为基础的医院信息系统的有效性和可行性，以便为公共卫生干预、资源分配和项目评估提供更准确的信息。本项目的具体目标是：1）。通过研究前瞻性队列中中国受试者血清转换前和血清转换后的充分表征标本，评估BED-CEIA测量HIV-1发病率的有效性。R 03奖项的第一年是为具体目标1服务。2）。要么（选项1）开始开发中国特定BED-CEIA的过程，要么（选项2）使用经验证的BED-CEIA计划试点HIS项目。我们是否采用选项1或2将取决于具体目标1的结果。R 03奖的第二年将根据科学的要求，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.