Evaluating the PrEP cascade in HIV-negative pregnant and breastfeeding women in South Africa (PrEP-PP)

项目摘要/摘要 南非艾滋病毒阴性的孕妇和哺乳期妇女感染艾滋病毒的风险极高 尽管南非增加了获得和启动抗逆转录病毒疗法(ART)的机会，但仍获得了这种药物。我们 迫切需要有效的干预措施，以减少孕妇和哺乳妇女的艾滋病毒发病率。 目前，PrEP是预防艾滋病毒感染的唯一有效的女性控制方法之一。 PREP-PP是对HIV-1血清阴性孕妇和产后进行暴露前预防(PrEP)的研究 南非两个城市初级卫生保健机构的妇女。有效利用PrEP可有助于 消除母体感染艾滋病毒，从而消除母婴传播。 然而，PrEP的有效性需要在性行为期间坚持，而坚持需要PrEP 接触、意识和咨询。目前，该领域的一个主要障碍是缺乏对妇女的 在非洲，孕期和哺乳期开始、保留和坚持PrEP。现在是 作为世卫组织，是时候评估如何最好地向脆弱的孕妇和哺乳期妇女提供PrEP 最近制定了为怀孕和哺乳妇女提供PrEP的指南，但有限 关于非洲孕妇和哺乳妇女可接受性、启蒙和依从性的数据，那里的负担 人类免疫缺陷病毒是最重要的。我们的研究将集中于以下具体目标： 1.确定妇女在PrEP级联中的分布(启动、保留和坚持)和 一组孕妇和母乳喂养的结局(艾滋病毒感染、传播和不良事件) 南非开普敦的妇女 2.评估与PrEP级联相关的患者和提供者层面的因素(启动、保留和 坚持)使用定量和定性方法 3.应用建立的数学模型来模拟PrEP叶栅改进对 避免了艾滋病毒感染(孕产妇和围产期) 我们的PrEP-PP研究对于了解孕期和孕期PrEP的级联反应是迫切和必要的。 在南非哺乳妇女，并确定与启动和遵守PrEP有关的因素 制定干预措施，确保高危人群中的每个人都能从预防接种计划中受益。结果来自于 PrEP-PP研究将为南非政府和该区域其他国家政府提供模式， 在感染艾滋病毒和围产期有风险的孕妇和哺乳期妇女中扩大PrEP分娩 艾滋病毒的传播，有助于消除围产期艾滋病毒的传播。

Project Summary/Abstract HIV-negative pregnant and breastfeeding women in South Africa are at extremely high risk of HIV acquisition despite increased access to and initiation of antiretroviral therapy (ART) in South Africa. We urgently need effective interventions to reduce HIV incidence in pregnant and breastfeeding women. Currently PrEP is one of the only female controlled methods that is effective for preventing HIV acquisition. PrEP-PP is a study of pre-exposure prophylaxis (PrEP) among HIV-1 seronegative Pregnant and Postpartum women in two South African urban primary health care facilities. Effective use of PrEP could contribute to eliminating maternal HIV acquisition, and hence eliminating mother to child HIV transmission (MTCT). However, PrEP efficacy requires adherence during periods of sexual activity and adherence requires PrEP access, awareness and counseling. Currently, a major obstacle in the field is the lack of knowledge of women's initiation, retention and adherence to PrEP during pregnancy and breastfeeding periods in Africa. Now is the time to evaluate how best to provide PrEP to vulnerable pregnant and breastfeeding women as WHO recently developed guidelines for providing PrEP in pregnancy and breastfeeding women but there are limited data on acceptability, initiation and adherence in pregnant and breastfeeding women in Africa where the burden of HIV is greatest. Our study will focus on the following specific aims: 1. Determine the distribution of women across the PrEP cascade (initiation, retention, and adherence) and outcomes (HIV acquisition, transmission, and adverse events) in a cohort of pregnant and breastfeeding women in Cape Town, South Africa 2. Evaluate patient and provider-level factors associated with the PrEP cascade (initiation, retention and adherence) using quantitative and qualitative approaches 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal) Our PrEP-PP study is urgent and essential to understand the PrEP cascade in pregnant and breastfeeding women in South Africa and to identify factors associated with PrEP initiation and adherence to develop interventions to ensure that everyone in this at-risk population can benefit from PrEP. The results from the PrEP-PP study will provide a model for the South African Government, and other Governments in the region, to scale up PrEP delivery among pregnant and breastfeeding women at risk of HIV acquisition and perinatal transmission and contribute to the elimination of perinatal HIV transmission.