Project 1 - Surveillance and monitoring systems to identify strategies to improve perinatal practices [Parent Title: PREVENTING INFANT INFECTIONS WITH IMPLEMENTATION SCIENCE IN MALAWI]

项目 1 - 监测和监测系统，以确定改善围产期实践的策略[父标题：马拉维通过实施科学预防婴儿感染]

• 批准号: 10701195
• 负责人: Friday Saidi
• 金额: $ 20.31万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701195
• 关键词: AIDS prevention; Achievement; Address; Adherence; Adopted; Adverse event; Affect; Africa South of the Sahara; Anti-Retroviral Agents; Area; Birth; Birth Rate; Breast Feeding; Caregivers; Categories; Childhood; Classification; Clinical; Data; Device or Instrument Development; Diagnosis; District Hospitals; Drug usage; Enrollment; Ensure; Exposure to; Face; Female; Fumarates; Goals; Grant; Growth; Growth and Development function; HIV; HIV Infections; Health; Human Milk; Human immunodeficiency virus test; Incidence; Infant; Infant Development; Infant Health; Infection; Injectable; Intervention; Lamivudine; Learning; Longitudinal Studies; Malawi; Maternal Exposure; Maternal Health; Methods; Monitor; Mother-to-child HIV transmission; Mothers; Neurocognitive; Nutrition Assessment; Oral; Outcome; Parents; Perinatal; Perinatal transmission; Pharmaceutical Preparations; Population; Postpartum Period; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Registries; Reporting; Research Personnel; Risk; Safety; Signal Transduction; Site; Small for Gestational Age Infant; Spontaneous abortion; Structure; System; Tenofovir; Time; United States Food and Drug Administration; Vertical Disease Transmission; Woman; World Health Organization; adverse pregnancy outcome; antenatal care; antiretroviral therapy; cohort; early childhood; emtricitabine; fighting; follow-up; high risk; implementation barriers; implementation science; improved; in utero; infant infection; infant morbidity; infant morbidity/mortality; maternal safety; medication safety; perinatal outcomes; pre-exposure prophylaxis; pregnant; prevent; programs; prospective; risk/benefit ratio; safety outcomes; stillbirth

PROJECT ABSTRACT New HIV infections during pregnancy and breastfeeding represents the last mile in achieving elimination of mother to child transmission (EMTCT) of HIV. However, little focus has been directed towards structured, antenatal care based strategies or interventions to prevent HIV acquisition among pregnant and breastfeeding women without HIV who receive HIV testing in ANC. Pregnant and breastfeeding women in sub-Saharan Africa (SSA) like Malawi face high rates of HIV incidence. Pre-exposure prophylaxis (PrEP) represents an important biomedical intervention in the growing fight for EMTCT. With good adherence, daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) has been shown to effectively reduce new HIV infections and is considered safe in pregnancy. Despite oral PrEP promise in reducing HIV acquisition, significant implementation challenges exist that result in poor adherence and losses to follow up. New PrEP options in the form of the recently U.S. Food and Drug Administration (FDA) approved long-acting Cabotegravir injectable (CAB-LA) offer more effective and discrete options that may help address issues of poor adherence. However, the safety data in pregnancy and breastfeeding remain limited for CAB-LA for PrEP. As women conceive while receiving PrEP for HIV prevention, obtaining pregnancy safety data for emerging PrEP antiretroviral drugs such as CAB-LA is important before widespread roll out of the drug in national PrEP programs. The overall goal of this project is therefore to establish and evaluate surveillance and monitoring systems among pregnant and breastfeeding women exposed to PrEP (oral PrEP and CAB-LA). Investigators will enroll a cohort of women who are judged to be at high risk of HIV acquisition categorized according to use of oral PrEP or injectable PrEP. In Aim 1, the investigators will establish a PrEP pregnancy registry into which all women who begin PrEP during pregnancy or who become pregnant while receiving PrEP will be entered into a PrEP in pregnancy registry and followed up to their pregnancy outcome. In Aim 2 the investigators will establish a prospective safety cohort of pregnant women with PrEP exposure. Women will be followed throughout pregnancy and delivery to obtain their birth outcomes. The mother-infant pairs will be followed up to about 12 months after delivery. For this aim they also evaluate acceptability of injectable PrEP and daily use of daily oral PrEP and will also determine whether rates of adverse pregnancy outcomes (preterm birth, stillbirth, miscarriages) and other clinical outcomes differ according to PrEP use status (CAB-LA vs. oral PrEP). Aim 3 focuses on assessing the growth and neurodevelopmental outcomes among the infants exposed to PrEP during pregnancy. Infants exposed to either oral PrEP or CAB-LA will have nutritional assessments based on World Health Organization (WHO) approved classifications.

项目摘要 怀孕和母乳喂养期间的新艾滋病毒感染代表了消除消除的最后一英里 艾滋病毒儿童传播（EMTCT）的母亲。但是，很少关注结构化， 基于产前护理的策略或干预措施，以防止孕妇和母乳喂养中的艾滋病毒收购 没有艾滋病毒的妇女在ANC接受艾滋病毒检查。撒哈拉以南非洲的怀孕和母乳喂养妇女 （SSA）像马拉维一样面临艾滋病毒发病率的高率。暴露前预防（PREP）代表一个重要的 生物医学干预在日益增长的EMTCT斗争中。每天的口服替诺福韦的依从性良好 富马酸/Emtricitabine（TDF/FTC）已显示可有效减少新的HIV感染，并被认为 怀孕安全。尽管口头准备承诺减少艾滋病毒的收购，但仍有重大的实施挑战 存在导致依从性不佳和跟进的损失。新的准备选项以最近美国的形式 食品药品监督管理局（FDA）批准了长效Cabotegravir注射（Cab-LA）提供更有效的 以及可能有助于解决依从性问题的离散选择。但是，怀孕的安全数据 母乳喂养仍有限制用于驾驶室的预备工作。作为妇女在接受艾滋病毒准备时受孕 预防，获得新兴的预抗逆转录病毒药物（例如CAB-LA）的妊娠安全数据很重要 在全国准备计划中广泛推出药物之前。因此，该项目的总体目标是 在孕妇和母乳喂养的妇女中建立和评估监视和监测系统 准备（口服准备和驾驶室）。调查人员将招募一群被认为有高风险的妇女 根据使用口腔准备或注射式准备进行分类的HIV获取。在AIM 1中，调查人员将 建立一个预怀孕登记处，所有在怀孕期间开始准备或成为的妇女 在接受准备时怀孕将进入怀孕注册表中的准备，然后跟进他们 怀孕结果。在AIM 2中，调查人员将与 准备曝光。在整个怀孕和分娩过程中，将遵循妇女的出生结果。这 分娩后大约12个月的母亲对母亲的对。为此，他们还评估 可接受的注射准备和日常使用日常口服准备的可接受性，还将确定不良率是否不利 怀孕结局（早产，死产，流产）和其他临床结果根据PREP有所不同 使用状态（驾驶室与口服准备）。 AIM 3专注于评估生长和神经发育结果 在怀孕期间暴露于准备的婴儿中。暴露于口腔准备或驾驶室的婴儿将有 基于世界卫生组织（WHO）批准分类的营养评估。