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
• 负责人: Andrew Marc Boulle
• 金额: $ 79.32万
• 依托单位: UNIVERSITY OF CAPE TOWN
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9330879
• 关键词: AIDS/HIV problem; Address; Adherence; Admission activity; Adult; Africa South of the Sahara; Anti-Retroviral Agents; Breast Feeding; CD4 Lymphocyte Count; Caring; Characteristics; Child; Child health care; Clinical; Cohort Analysis; Cohort Studies; Communicable Diseases; Complex; Conceptions; Congenital Abnormality; Country; Data; Data Set; Diagnosis; Disease; Early treatment; Effectiveness; Ensure; Environment; Epidemic; Evaluation; Event; Exposure to; Family; Future; Government; Guidelines; HIV; HIV Infections; HIV therapy; HIV-exposed uninfected infant; Health; Health Information System; Hospitals; Infant; Information Systems; Intervention; Knowledge; Laboratories; Life; Link; Low Birth Weight Infant; Maternal Health; Maternal and Child Health; Measures; Mental Health; Modeling; Monitor; Mother-to-child HIV transmission; Mothers; Outcome; Patients; Perinatal; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnancy Outcome; Pregnant Women; Prevention; Prevention Guidelines; Preventive; Program Effectiveness; Province; Public Sector; Recording of previous events; Regimen; Reporting; Research; Research Infrastructure; Risk; Safety; Sentinel; Serious Adverse Event; Seroprevalences; Services; Severities; Site; South Africa; System; Testing; Vertical Disease Transmission; Viral Load result; Vital Status; Woman; adverse pregnancy outcome; antenatal; antiretroviral therapy; base; cohort; congenital anomaly; cost; electronic data; feeding; follow-up; health care delivery; improved; innovation; insight; mathematical model; mortality; novel; perinatal health; perinatal outcomes; population based; pregnant; prenatal exposure; prevent; programs; public health relevance; sexual HIV transmission; stillbirth; transmission process; treatment program; trend

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)：针对艾滋病毒感染妇女的普遍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、改善产妇健康、减少艾滋病毒的性传播以及简化治疗计划方面具有许多优势。在怀孕和受孕期间增加抗逆转录病毒药物暴露对母亲和她们的孩子的安全性尚未完全确立，而且有人担心母亲的依从性和计划的有效性。调查这些变化的影响是复杂的，因为许多环境中的临床和信息系统薄弱，指南和服务现实迅速变化，以及难以确保足够数量的长期跟踪 以排除潜在的有害影响。南非西开普省目前的艾滋病毒产前血清阳性率为19%，艾滋病毒垂直传播估计为2%。该省每年为10万名母亲提供产妇保健，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妇女推出了终身普遍抗逆转录病毒疗法。该省在全面评估这一指南变化方面处于独特的地位，因为可以获得关于ART计划的电子数据，并且能够通过唯一的健康标识符链接到一系列其他数据集，以改善后续治疗、确定怀孕和ART暴露、化验值、生命状态数据和其他结果。本提案旨在评估指南修改对以下方面的影响：1)预防母婴传播和抗逆转录病毒治疗计划对参与的妇女的有效性；2)产前和孕期更多的抗逆转录病毒药物暴露对孕产妇和围产期健康结果的影响；3)在子宫内暴露于抗逆转录病毒药物的儿童对儿童健康结果的影响；以及最后4)对政府抗逆转录病毒治疗计划和流行病本身的影响。在每一级评估中，以人口为基础的全省范围的活动与更深入地探讨临床和操作问题的哨点活动相结合。所有哨点活动都设在同一地点，以提高业务效率，而全省范围内的所有数据活动将由一个团队承担。该计划的有效性将通过对整个省级ART队列的队列分析和对哨点900名女性的详细队列研究来评估。ART队列包括每年开始ART的3.5万名成年患者。将通过省级死亡率报告和围产期审计来评估孕产妇和围产期的健康结果，这两种审计都具有很高的完整性，并通过参与国家怀孕暴露登记和出生缺陷监测登记中的哨点而得到赞扬。将通过入院跟踪新生儿后儿童的健康结果，对于来自PER的儿童，将对入院情况进行审查，以核实出院诊断。将通过基于新的国家一级艾滋病毒和人口模型的数学建模来探索方案和流行病的影响。