B positive_A population based evaluation of expanded ART access in pregnancy

B 阳性_基于人群的妊娠期扩大 ART 获取的评估

基本信息

  • 批准号:
    8729081
  • 负责人:
  • 金额:
    $ 70.92万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-09-01 至 2019-08-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Universal three-drug antiretroviral therapy (ART) for HIV-infected women offers many advantages in terms of preventing HIV transmission to children, safer breastfeeding, improved maternal health, reduced sexual transmission of HIV, and simplified treatment programs. Safety of increased ART exposure during pregnancy and conception for mothers and their children is not fully established, and there are concerns about maternal adherence and program effectiveness. Investigating the impact of these changes is complex due to weak clinical and information systems in many settings, rapidly changing guidelines and service realities, and difficulty ensuring long term follow-up of sufficient numbers of children to exclude potential harmful effects. The current HIV antenatal seroprevalence in the Western Cape province of South Africa is 19% with vertical transmission of HIV estimated at 2%. Providing maternity care to 100,000 mothers a year, the province has a long history of innovation in PMTCT programs; recently introducing life-long universal ART for HIV- infected pregnant or breast-feeding women. The province is uniquely placed to comprehensively evaluate this guideline change due to the availability of electronic data on the ART program, and the ability to link via a unique health identifier to a range of other datasets to improve follow-u, ascertainment of pregnancy and ART exposure, laboratory values, vital status data and other outcomes. This proposal seeks to evaluate the impact of the guideline change on: 1) the effectiveness of PMTCT and ART programs for participating women based; 2) the impact of increased ART exposure antenatally and around conception on maternal and perinatal health outcomes; 3) the impact on child health outcomes for children exposed in utero to ART; and finally 4) the impact on the governmental ART program and on the epidemic itself. At each level of evaluation, a population-based province-wide activity is paired with a sentinel site activity which probes clinical and operational issues in greater depth. All of the sentinel site activities are located in the same sites to improve operational efficiency, while all of the province-wide data activities will be undertaken by a single team. Program effectiveness will be assessed both through cohort analyses of the entire provincial ART cohort of 35,000 adult patients starting ART each year, and a detailed cohort study of 900 women in the sentinel site. Maternal and perinatal health outcomes will be assessed through provincial mortality reporting and perinatal audits which both have high levels of completeness, complimented by participation at the sentinel site in the national pregnancy exposure (PER) register and birth defects surveillance register. Post-neonatal child health outcomes will be tracked through hospital admissions, which for children from the PER, will be reviewed to verify discharge diagnoses. Program and epidemic impact will be explored through mathematical modeling based on a new country level HIV and demographic model.
描述(由申请人提供):艾滋病毒感染妇女的通用三药抗逆转录病毒疗法(ART)在预防艾滋病毒传播给儿童、更安全的母乳喂养、改善孕产妇健康、减少艾滋病毒的性传播和简化治疗方案方面具有许多优势。在怀孕和受孕期间增加抗逆转录病毒药物暴露对母亲及其子女的安全性尚未完全确定,人们对母亲的依从性和方案的有效性表示担忧。调查这些变化的影响是复杂的,因为在许多情况下,临床和信息系统薄弱,指南和服务现实迅速变化,难以确保足够数量的长期随访 以排除潜在的有害影响。 目前南非西开普省的产前艾滋病毒血清阳性率为19%,艾滋病毒垂直传播估计为2%。该省每年为100 000名母亲提供孕产妇保健,在预防母婴传播方案方面有着悠久的创新历史;最近为感染艾滋病毒的孕妇或哺乳期妇女引入了终身通用抗逆转录病毒疗法。由于ART计划的电子数据可用,并且能够通过唯一的健康标识符与一系列其他数据集链接,以改善随访,确定妊娠和ART暴露,实验室值,生命状态数据和其他结果,因此该省处于全面评估这一指南变化的独特地位。 该提案旨在评估指南变更对以下方面的影响:1)基于参与妇女的预防母婴传播和抗逆转录病毒疗法方案的有效性; 2)产前和受孕前后抗逆转录病毒疗法暴露增加对孕产妇和围产期健康结局的影响; 3)宫内暴露于抗逆转录病毒疗法的儿童对儿童健康结局的影响;最后4)对政府ART计划和流行病本身的影响。 在每一级的评价中,一项以人口为基础的全省范围的活动与一项更深入地探讨临床和业务问题的哨点活动相结合。所有的监控点活动都位于同一地点,以提高运营效率,而所有全省范围的数据活动将由一个团队进行。将通过对每年开始ART的35,000名成人患者的整个省级ART队列进行队列分析,以及对哨兵站点的900名妇女进行详细的队列研究来评估计划的有效性。将通过省级死亡率报告和围产期审计评估产妇和围产期健康结果,两者都具有高度的完整性,并辅之以在监测点参与国家妊娠暴露登记和出生缺陷监测登记。新生儿后期的儿童健康结果将通过入院进行跟踪,对于来自PER的儿童,将进行审查以核实出院诊断。将根据新的国家一级艾滋病毒和人口模型,通过数学建模探讨方案和流行病的影响。

项目成果

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Andrew Marc Boulle其他文献

Andrew Marc Boulle的其他文献

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{{ truncateString('Andrew Marc Boulle', 18)}}的其他基金

B positive_A population based evaluation of expanded ART access in pregnancy
B 阳性_基于人群的妊娠期扩大 ART 获取的评估
  • 批准号:
    9355449
  • 财政年份:
    2014
  • 资助金额:
    $ 70.92万
  • 项目类别:
B positive_A population based evaluation of expanded ART access in pregnancy
B 阳性_基于人群的妊娠期扩大 ART 获取的评估
  • 批准号:
    9330879
  • 财政年份:
    2014
  • 资助金额:
    $ 70.92万
  • 项目类别:

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