Optimizing repeat HIV testing during pregnancy and postpartum for PMTCT

优化孕期和产后艾滋病毒重复检测以预防母婴传播

• 批准号: 8992057
• 负责人: Alison L Drake
• 金额: $ 12.64万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-10 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8992057
• 关键词: AIDS prevention; Achievement; Acute; Address; Advocate; Africa South of the Sahara; Award; Biological; Breast Feeding; Caring; Characteristics; Child; Chronic; Clinic; Clinical Research; Collaborations; Communicable Diseases; Cost Effectiveness Analysis; Cost of Illness; Coupled; Data; Detection; Disease Progression; Effectiveness; Environment; Epidemiologic Studies; Epidemiology; Evidence based intervention; Future; Goals; Guidelines; HIV; HIV Infections; HIV risk; Heterosexuals; High Risk Woman; Human immunodeficiency virus test; Immunization; Incidence; Individual; Infant; Infection; Interdisciplinary Study; Kenya; Knowledge; Lead; Link; Literature; Logistic Regressions; Maternal and Child Health; Mentored Research Scientist Development Award; Mentors; Mentorship; Methodology; Modeling; Mothers; Pharmaceutical Preparations; Pilot Projects; Policies; Positioning Attribute; Postpartum Period; Postpartum Women; Predisposition; Pregnancy; Pregnant Women; Prevalence; Prevention; Prevention approach; Prevention strategy; Process; Public Health; Publications; Reproductive Health; Research; Research Personnel; Resources; Risk; Site; Testing; Time; Time and Motion Studies; Training; Universities; Validation; Visit; Washington; Woman; antiretroviral therapy; base; career; cohort; cost; cost effective; cost effectiveness; data exchange; design; experience; frontier; high risk; implementation science; improved; intervention program; mathematical model; meetings; pregnant; programs; public health relevance; scale up; skills; transmission process

 DESCRIPTION (provided by applicant): The K01 Mentored Research Scientist Development Award will provide the Candidate with the protected time to develop skills in implementation science, mathematical modeling of infectious diseases, and cost- effectiveness analysis, and use these skills in combination with robust epidemiological methodology to become an independent investigator focused on programmatic and public health approaches to HIV prevention for women. The Candidate's long-term objective is to become a global leader in HIV prevention and reproductive health, using implementation science and mathematical modeling to prioritize, design, implement, and evaluate evidence-based interventions, which will help transform public health programs, and guide policy. The proposed 5-year training plan will support the achievement of these objectives with the assistance of the outstanding, interdisciplinary research environment at the University of Washington (UW) and the Kenya Research Program, experienced mentors and advisors, and long-standing collaborations with Kenyan investigators. The training plan was carefully developed with the K01 mentors to include didactic coursework, mentored training, and scientific meetings to fill a gap in the Candidate's training, which will help her develop a unique combination of skills and experience. The mixture of formal training along with a two-tiered approach to mentorship, which includes two co-mentors and a mentoring team, were strategically designed to complete the research and career objectives during the award period and prepare the Candidate for an independent research career. The career goals to be achieved during the award period are: 1) gain knowledge and skills in implementation science and translational clinical research for HIV prevention; 2) develop skills in the construction and validation of mathematical models of infectious diseases to determine program and intervention impacts; 3) obtain practical skills in the conduct of costing and cost-effectiveness analysis, from programmatic and societal perspectives; 4) build the Candidate's research portfolio and publication record, generate data and scientific questions for a future R01, and transition the Candidate into an independent academic career. Research Plan: Risk of HIV acquisition during pregnancy and postpartum is high in sub-Saharan Africa. While current prevention of mother-to-child HIV transmission (PMTCT) programs are designed to detect and treat women with chronic HIV infections, women who miss antenatal HIV testing, are in the process of seroconverting, or who acquire HIV after initial testing have infections that go undetected. Mother-to-child HIV transmission (MTCT) risk is substantially higher among women with acute infection than chronic infection. As PMTCT coverage expands and women with chronic HIV receive triple-drug antiretroviral therapy (ART), an increasing proportion of HIV infected infants will be due to undetected acute maternal HIV, making this an important frontier to address in elimination of MTCT (eMTCT) efforts. In this proposal, we aim to identify the optimal time(s) to conduct repeat maternal HIV testing for PMTCT. The specific aims of the study are to: 1) determine the prevalence of incident or undiagnosed HIV infections among pregnant and postpartum women; 2) model the number of MTCT cases averted by conducting repeat HIV testing using a cohort decision-analytic MTCT model; 3) estimate the incremental costs and cost- effectiveness per case of infant HIV infection averted of repeat testing under different repeat testing strategies compared to no repeat testing. To conduct this study, we will test 4650 women, 930 at each time-point: 3rd trimester (if previously tested HIV negative during pregnancy); delivery; 6 weeks, 6 months, and 9 months postpartum. We will use the prevalence estimates of incident and undiagnosed maternal HIV infection from Aim 1, programmatic PMTCT data at study sites, and the scientific literature to construct and parameterize a cohort decision-analytic MTCT model and determine the number of infant HIV infections that could be averted by implementing this retesting strategy or strategies. We will build upon the MTCT model developed for Aim 2 and use costing data to evaluate cost-effectiveness for Aim 3. Pilot data generated from this study will be used to develop a future, large-scale implementation science study of optimal HIV repeat testing strategy/strategies for PMTCT and can also be leveraged for future HIV prevention studies (i.e., impact on heterosexual transmission, PMTCT in future pregnancies, and maternal HIV disease progression).

 描述（由适用提供）：K01指导的研究科学家发展奖将为候选人提供受保护的时间，以发展实施科学，传染病的数学建模和成本效益分析的技能，并将这些技能与强大的流行病学方法结合起来，成为针对妇女预测的程序和公共健康方法的独立研究者。候选人的长期目标是使用实施科学和数学建模来优先级，设计，实施和评估基于证据的干预措施，以帮助改变公共卫生计划和指导政策。拟议的为期5年的培训计划将在华盛顿大学（UW）的杰出跨学科研究环境和肯尼亚研究计划，经验丰富的导师和顾问以及与肯尼亚调查人员的长期合作的协助下，支持这些目标的实现。培训计划与K01导师进行了精心制定，包括教学课程，指导的培训和科学会议，以填补候选人培训的空白，这将有助于她发展独特的技能和经验。正式培训与两层指导方法的混合在一起，其中包括两名联合主机和一个心理团队，旨在在奖励期间完成研究和职业目标，并为候选人做好独立研究职业的准备。奖励期间要实现的职业目标是：1）获得实施科学方面的知识和技能，并翻译了预防HIV的临床研究； 2）发展传染病的数学模型的构建和验证技能，以确定计划和干预影响； 3）从程序和社会的角度来获得成本和成本效益分析的实践技能； 4）建立候选人的研究组合和出版记录，为未来R01生成数据和科学问题，并将候选人转变为独立的学术职业。研究计划：撒哈拉以南非洲怀孕期间和产后艾滋病毒的风险很高。尽管目前旨在检测和治疗患有慢性艾滋病毒感染的妇女的妇女，但错过触角HIV检测，正在使用血清抗血清反应的妇女，或者在初步测试后获得HIV的过程虽然目前的预防母亲艾滋病毒传播（PMTCT）计划旨在检测和治疗妇女。急性感染的女性中，母子艾滋病毒传播（MTCT）的风险大大高于慢性感染。随着PMTCT覆盖范围的扩大，患有慢性艾滋病毒的女性接受三毒病毒疗法（ART），越来越多的HIV感染婴儿将是由于未发现的急性孕产妇HIV造成的，这是消除MTCT（EMTCT）努力的重要领域。在此提案中，我们旨在确定对PMTCT进行重复母体HIV测试的最佳时间。该研究的具体目的是：1）确定孕妇和产后妇女中出现或未诊断的HIV感染的患病率； 2）模拟通过使用队列决策分析MTCT模型进行重复HIV测试的MTCT病例的数量； 3）与没有重复测试相比，在不同的重复测试策略下，在不同的重复测试策略下避免重复测试的婴儿艾滋病毒感染的每病例的增量成本和成本效益。为了进行这项研究，我们将在每个时间点测试4650名女性，930名：第三个孕期（如果在怀孕期间先前对HIV为阴性）；送货;产后6周，6个月和9个月。我们将利用AIM 1，研究地点的程序化PMTCT数据以及科学文献的事件和未诊断的遗传HIV感染的普遍估计值来构建和参数化队列决策分析MTCT模型，并确定可以通过实施这种验证策略或策略来避免的婴儿HIV感染的数量。 We will build upon the MTCT model developed for Aim 2 and use costing data to evaluate cost-effectiveness for Aim 3. Pilot data generated from this study will be used to develop a future, large-scale implementation science study of optimal HIV repeat testing strategies/strategies for PMTCT and can also be leveraged for future HIV prevention studies (i.e., impact on heterosexual transmission, PMTCT in future pregnancy, and maternal HIV disease progression).