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

项目摘要 在怀孕和哺乳期间新的艾滋病毒感染是实现消除 艾滋病毒母婴传播(EMTCT)。然而，很少有人将重点放在结构化、 以产前护理为基础的策略或干预措施，以防止孕妇和母乳喂养中感染艾滋病毒 在非国大接受艾滋病毒检测的未感染艾滋病毒的妇女。撒哈拉以南非洲的孕妇和哺乳期妇女 像马拉维这样的特别行政区(SSA)面临艾滋病毒高发病率。暴露前预防(PrEP)是一种重要的 在日益激烈的EMTCT斗争中的生物医学干预。依从性好，每日口服替诺福韦异丙酚 富马酸/恩曲他滨(TDF/FTC)已被证明能有效减少新的艾滋病毒感染，并被认为是 怀孕期间安全。尽管PrEP口头承诺减少艾滋病毒感染，但重大的实施挑战 存在导致依从性不佳且无法跟进的问题。最近美国推出的新PrEP选项 食品和药物管理局(FDA)批准长效卡替格列韦注射剂(CAB-LA)提供更有效的药物 以及可能有助于解决遵守情况不佳的问题的离散选择。然而，怀孕期间的安全数据 对于PrEP的CAB-LA，母乳喂养仍然有限。女性在接受艾滋病毒PrEP治疗时怀孕 预防，获得新出现的PrEP抗逆转录病毒药物如CAB-LA的怀孕安全性数据很重要 在国家PrEP计划中广泛推广该药物之前。因此，该项目的总体目标是 建立和评估孕妇和哺乳期妇女暴露的监测和监测系统 至PrEP(口服PrEP和CAB-LA)。调查人员将招募一组被认为有高风险的女性 HIV感染根据口服PrEP或注射PrEP的使用情况进行分类。在目标1中，调查人员将 建立PrEP妊娠登记，所有在怀孕期间开始PrEP或成为 在接受PrEP期间怀孕的人将被输入到妊娠登记处的PrEP中，并跟踪到他们 妊娠结局。在目标2中，研究人员将建立一个预期的安全队列，这些孕妇患有 准备曝光。妇女将在整个怀孕和分娩过程中接受跟踪，以获得她们的分娩结果。这个 母婴配对将在分娩后约12个月进行追踪。为了达到这个目的，他们还评估 注射用PrEP的可接受性和每日口服PrEP的日常使用情况，也将决定不良反应的发生率 妊娠结局(早产、死产、流产)和其他临床结局因PrEP而异 使用状态(CAB-LA与口服PrEP)。目标3侧重于评估生长和神经发育结果 在孕期接触PrEP的婴儿中。接触口服PrEP或CAB-LA的婴儿将有 根据世界卫生组织(WHO)批准的分类进行的营养评估。

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.