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：
9764401
负责人：
Emma Kate Kalk
金额：
$ 79.92万
依托单位：
UNIVERSITY OF CAPE TOWN
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 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9764401
关键词：
AIDS/HIV problem Address Adherence Adult Africa South of the Sahara Anti-Retroviral Agents Breast Feeding CD4 Lymphocyte Count Caring Characteristics Child Child Health 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 Hospitalization Infant Information Systems Intervention Knowledge Laboratories Life Link Longterm Follow-up 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 Service delivery model 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 health care delivery improved innovation insight mathematical model mortality novel perinatal health perinatal outcomes perinatal period population based pregnant prenatal exposure prevent programs public health relevance sexual HIV transmission stillbirth transmission process treatment program trend

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）：针对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。母亲及其子女在怀孕和受孕期间增加抗逆转录病毒治疗的安全性尚未完全确定，并且人们对母亲的依从性和计划的有效性感到担忧。由于许多环境下临床和信息系统薄弱、指南和服务现实快速变化以及难以确保足够数量的长期随访，调查这些变化的影响是复杂的儿童，以排除潜在的有害影响。目前南非西开普省的艾滋病毒产前血清流行率为 19%，艾滋病毒垂直传播估计为 2%。该省每年为 10 万名母亲提供孕产保健，在预防母婴传播项目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普遍的抗逆转录病毒疗法。由于 ART 计划的电子数据的可用性，以及通过独特的健康标识符链接到一系列其他数据集的能力，以改善妊娠和 ART 的随访、确定，该省在全面评估这一指南变化方面处于独特的地位暴露、实验室值、生命状态数据和其他结果。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 PMTCT 和 ART 计划的有效性； 2) 产前和受孕前后增加抗逆转录病毒治疗对孕产妇和围产期健康结果的影响； 3) 子宫内接受抗逆转录病毒治疗的儿童对儿童健康结果的影响；最后 4) 对政府 ART 计划和流行病本身的影响。在每个评估级别，基于人口的全省范围活动与哨点活动相结合，更深入地探讨临床和操作问题。所有哨点活动都位于同一站点，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承担。将通过对每年开始 ART 的整个省 ART 队列（包括 35,000 名成年患者）的队列分析以及对哨点地点 900 名女性的详细队列研究来评估计划的有效性。孕产妇和围产期健康结果将通过省级死亡率报告和围产期审计进行评估，两者都具有很高的完整性，并通过哨点参与国家妊娠暴露（PER）登记册和出生缺陷监测登记册来补充。将通过入院来跟踪新生儿后儿童的健康结果，对于来自 PER 的儿童，将对其进行审查以核实出院诊断。将通过基于新的国家级艾滋病毒和人口模型的数学模型来探讨计划和流行病的影响。

项目成果

期刊论文数量（12）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Assessing the value of Western Cape Provincial Government health administrative data and electronic pharmacy records in ascertaining medicine use during pregnancy.

评估西开普省政府卫生管理数据和电子药房记录在确定怀孕期间药物使用方面的价值。

DOI：
发表时间：
2018-04-25
期刊：
影响因子：
0
作者：
Mehta, U;Heekes, A;Kalk, E;Boulle, A
通讯作者：
Boulle, A

Trends in maternal and neonatal mortality in South Africa: a systematic review protocol.

南非孕产妇和新生儿死亡率趋势：系统评价方案。

DOI：
发表时间：
2017
期刊：
影响因子：
3.7
作者：
Damian, Damian J;Njau, Bernard;Lisasi, Ester;Msuya, Sia E;Boulle, Andrew
通讯作者：
Boulle, Andrew

Pharmacovigilance: A public health priority for South Africa.

药物警戒：南非的公共卫生优先事项。

DOI：
发表时间：
2017
期刊：
影响因子：
0
作者：
Mehta, Ushma;Kalk, Emma;Boulle, Andrew;Nkambule, Portia;Gouws, Joey;Rees, Helen;Cohen, Karen
通讯作者：
Cohen, Karen

Why South Africa urgently needs to support the development of pregnancy exposure registries.

为什么南非迫切需要支持妊娠暴露登记的发展。

DOI：
发表时间：
2019
期刊：
影响因子：
0
作者：
Mehta, U;Kalk, E;Fairlie, L;Boulle, A;Rees, H
通讯作者：
Rees, H

Increased infectious-cause hospitalization among infants who are HIV-exposed uninfected compared with HIV-unexposed.

与未感染艾滋病毒的婴儿相比，未感染艾滋病毒的婴儿因感染原因住院的人数增加。

DOI：
发表时间：
2021-11-15
期刊：
影响因子：
0
作者：
Anderson, Kim;Kalk, Emma;Madlala, Hlengiwe P;Nyemba, Dorothy C;Kassanjee, Reshma;Jacob, Nisha;Slogrove, Amy;Smith, Mariette;Eley, Brian S;Cotton, Mark F;Muloiwa, Rudzani;Spittal, Graeme;Kroon, Ma;Boulle, Andrew;Myer, Landon;Davies, Mary
通讯作者：
Davies, Mary