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

项目概要/摘要 南非艾滋病毒阴性孕妇和哺乳期妇女感染艾滋病毒的风险极高 在南非，尽管获得和开始抗逆转录病毒疗法的机会增加，但艾滋病毒/艾滋病感染仍然存在。我们 迫切需要采取有效的干预措施，以降低孕妇和哺乳期妇女的艾滋病毒感染率。 目前，PrEP是唯一有效预防艾滋病毒感染的女性控制方法之一。 PrEP-PP是一项在HIV-1血清阴性孕妇和产后妇女中进行的暴露前预防（PrEP）研究 两个南非城市初级保健设施的妇女。有效使用PrEP可能有助于 消除孕产妇感染艾滋病毒，从而消除母婴传播艾滋病毒。 然而，PrEP功效需要在性活动期间坚持，坚持需要PrEP 获得、认识和咨询。目前，这一领域的一个主要障碍是缺乏对妇女的知识， 非洲在怀孕和哺乳期间开始、保持和坚持PrEP。现在是 是时候评估如何最好地为脆弱的孕妇和哺乳期妇女提供PrEP了， 最近制定了为怀孕和哺乳妇女提供PrEP的指南，但 非洲孕妇和哺乳期妇女的可接受性、开始和坚持数据， 艾滋病是最大的。我们的研究将侧重于以下具体目标： 1.确定PrEP级联中女性的分布（启动、保留和依从性）， 妊娠和母乳喂养队列的结局（HIV感染、传播和不良事件） 南非开普敦的女性 2.评估与PrEP级联相关的患者和提供者水平因素（启动、保留和 坚持）使用定量和定性方法 3.应用已建立的数学模型模拟PrEP级联改进对 避免艾滋病毒感染（孕产妇和围产期） 我们的PrEP-PP研究对于了解孕妇和孕妇中的PrEP级联反应非常紧迫和必要 南非母乳喂养妇女，并确定与PrEP启动和坚持相关的因素， 制定干预措施，以确保这一高危人群中的每个人都能从PrEP中受益。 PrEP-PP研究将为南非政府和该地区其他政府提供一个模式， 在有感染艾滋病毒风险和围产期风险的孕妇和哺乳期妇女中扩大PrEP分娩 预防艾滋病毒的传播，并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.