Adherence to Pre-Exposure Prophylaxis for HIV Prevention in Pregnancy

摘要 该F32项目旨在推进用于预防艾滋病毒的暴露前预防（PrEP）的翻译， 感染艾滋病毒的高危孕妇。全世界近80%感染艾滋病毒的年轻女性居住在 在撒哈拉以南非洲，青年妇女的新感染人数是该区域青年男子的两倍。艾滋病毒 据估计，居住在艾滋病毒高流行地区的妇女在怀孕期间的发病率约为2-8%， 产后-发病率与高危人群相似，如女性性工作者和艾滋病毒血清不一致 夫妻。孕妇和哺乳期妇女中的急性艾滋病毒感染对亚 在撒哈拉非洲，急性孕产妇艾滋病毒占所有艾滋病毒母婴传播的26%。PrEP 是一项由女性控制的艾滋病毒预防战略，可降低艾滋病毒感染率， 在无法在伴侣关系中就艾滋病毒预防问题进行谈判的孕妇中预防艾滋病毒。世界 卫生组织建议所有有艾滋病毒重大风险（发病率>3%）的人都使用PrEP 目前正在肯尼亚有计划地推广预防接种和预防接种，包括在孕妇中推广。 迄今为止，尚未对非洲孕妇的PrEP依从性进行系统评估。拟议 F32研究提案利用了正在进行的PrEP实施集群随机试验的数据， 孕妇中的HIV预防（R 01 AI 125498 -01，PI：John-Stewart），以评价开放标签PrEP摄取 和坚持。在目标1中，我们将使用基线数据来确定开放标签PrEP摄取的预测因素， 在产前护理期间提供PrEP的妇女。识别PrEP摄取预测因子将告知谁 可能需要加强咨询，以优化PrEP提供。在目标2中，我们将评估PrEP是否 在产后期间，在怀孕期间使用PrEP的女性中， 药物水平数据的纵向建模。目标2的结果将有助于了解PrEP依从性， 使用血液样本中的药物检测的真实世界设置。这将是第一项评估PrEP的研究 孕妇之间的依从性，并将提供数据，告知PrEP依从性干预措施， 重要人口。拟议的研究计划将为F32候选人进行独立研究做好准备， 护士科学家，并提供严格的博士后培训，包括1）分析数据的经验， 干预性研究，2）新方法的正式培训-包括在临床研究中使用生物标志物数据 重复测量的纵向分析和3）PrEP内容领域专业知识的发展 这是一个新出现的领域，对这一强有力的艾滋病毒预防战略的有效性至关重要。

ABSTRACT This F32 project aims to advance translation of pre-exposure prophylaxis (PrEP) for HIV prevention for pregnant women at high risk of HIV infection. Nearly 80% of young women living with HIV worldwide reside in sub-Saharan Africa and new infections among young women are double that of young men in the region. HIV incidence is an estimated ~2-8% in women residing in high HIV prevalence regions during pregnancy and postpartum—an incidence rate similar to high-risk groups like female sex workers and HIV-serodiscordant couples. Acute HIV infection among pregnant and breastfeeding women poses a double burden in sub- Saharan Africa where acute maternal HIV accounts for 26% of all mother-to-child transmissions of HIV. PrEP is a female-controlled HIV prevention strategy that reduces HIV incidence in adherent women and could prevent HIV in pregnant women who are unable to negotiate HIV prevention within partnerships. The World Health Organization recommends PrEP for all individuals at substantial risk (>3% incidence rate) of HIV acquisition and PrEP is currently being rolled out programmatically in Kenya, including in pregnant women. PrEP adherence among pregnant African women has not been systematically evaluated to date. The proposed F32 research proposal leverages data from an ongoing cluster-randomized trial of PrEP implementation for HIV prevention in pregnant women (R01 AI125498-01, PI: John-Stewart) to evaluate open-label PrEP uptake and adherence. In Aim 1, we will use baseline data to determine predictors of open-label PrEP uptake among women who are offered PrEP during antenatal care. Identification of PrEP uptake predictors will inform who may need intensified counseling to optimize PrEP provision. In Aim 2, we will evaluate whether PrEP adherence declines during the postpartum period among women who initiate PrEP in pregnancy using longitudinal modeling of drug level data. Results from Aim 2 will contribute to understanding PrEP adherence in real-world settings using drug detection in blood samples. This will be the first study to evaluate PrEP adherence among pregnant women and will provide data to inform PrEP adherence interventions for this important population. The proposed research plan will prepare the F32 candidate for independent research as a nurse-scientist and provide rigorous postdoctoral training including 1) experience analyzing data from interventional studies, 2) formal training in new methods—including use of biomarker data in clinical research and longitudinal analyses with repeated measures and 3) development of content area expertise in PrEP adherence, an emerging area critical to effectiveness of this powerful HIV prevention strategy.