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 怀孕和哺乳期间新感染艾滋病毒是实现消除艾滋病毒/艾滋病的最后一英里。 母婴传播（EMTCT）然而，很少有人关注结构化、 预防孕妇和哺乳期妇女感染艾滋病毒的基于产前保健的战略或干预措施 撒哈拉以南非洲的孕妇和哺乳期妇女 (SSA)像马拉维这样的国家面临着高艾滋病发病率。暴露前预防（PrEP）是一种重要的 在日益激烈的EMTCT斗争中进行生物医学干预。坚持良好，每日口服替诺福韦酯 富马酸/恩曲他滨（TDF/FTC）已被证明可有效减少新发HIV感染， 怀孕期间安全。尽管口服PrEP有望减少艾滋病毒感染，但实施方面存在重大挑战 存在导致依从性差和失访的问题。新的PrEP选项的形式，最近美国。 美国食品药品监督管理局（FDA）批准的长效卡博特拉韦注射剂（CAB-LA）提供更有效的 以及可以帮助解决依从性差的问题的离散选项。然而，妊娠期的安全性数据 和母乳喂养仍然是有限的CAB-LA的PrEP。由于妇女怀孕，而接受PrEP的艾滋病毒 预防，获得新出现的PrEP抗逆转录病毒药物（如CAB-LA）的妊娠安全性数据非常重要 在国家PrEP计划中广泛推出药物之前。因此，该项目的总体目标是 建立和评估对接触过艾滋病毒的孕妇和哺乳期妇女的监测和监督系统 PrEP（口服PrEP和CAB-LA）。研究人员将招募一组被判定为高风险的女性， 根据口服PrEP或注射PrEP的使用对HIV感染进行分类。在目标1中，研究人员将 建立PrEP妊娠登记处，所有在妊娠期间开始PrEP或 怀孕，而接受PrEP将进入PrEP在怀孕登记处，并跟进他们的 妊娠结局。在目标2中，研究者将建立一个孕妇的前瞻性安全性队列， PrEP暴露。将在整个妊娠和分娩期间对妇女进行随访，以获得其出生结果。的 对母婴进行随访，直至分娩后约12个月。为此，他们还评估了 可注射PrEP和每日口服PrEP的每日使用的可接受性，也将确定不良反应的发生率 根据PrEP，妊娠结局（早产、死产、流产）和其他临床结局不同 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 在怀孕期间暴露于PrEP的婴儿中。暴露于口服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.