Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa

项目摘要：与非怀孕和产后相比，艾滋病毒发病率增加一倍 强调迫切需要为高危人群量身定做的预防措施 怀孕和哺乳的妇女。据估计，母体感染艾滋病毒导致三分之一的人 婴儿感染艾滋病毒。南非预计未来十年将有超过7.6万名婴儿感染艾滋病毒；其中三分之一 可以通过消除产妇感染艾滋病毒来预防。孕期暴露前预防(PrEP)和 母乳喂养在预防艾滋病毒方面是安全和有效的。然而，PrEP的使用率在怀孕期间仍然很低，并有所下降 在产后急转直下。我们的团队由流行病学、行为科学、 加州大学洛杉矶分校的孕妇的健康经济学和艾滋病毒预防 开普敦大学。我们共同实施了首批将PrEP整合到 南非的产前护理(“PrEP-PP”；R01MH116771)。我们建议测试一种新的策略来优化 在南非的孕妇和产后妇女中进行准备。我们的随机对照试验(RCT)是 解决孕产妇使用PrEP的主要障碍，并评估成本效益，以便为国家政策提供信息。 这项试验建立在我们早期工作的基础上，证明了一种 对参与者和她的伴侣(S)进行的一揽子干预措施，包括PrEP、艾滋病毒自我检测(HIVST)，以及 增强的遵从性咨询(具有关于遵从性的生物反馈)与家庭PrEP交付相结合 想要服用PrEP但难以坚持的女性。我们开发并试行了一种新的干预方法 题为《分步护理优化孕期和产后妇女PrEP有效性》(SCOPE-PP) 这解决了每天服用PrEP的障碍，减少了诊所就诊频率，并赋予妇女 坚持PrEP。我们将评估SCOPE-PP在有风险的孕妇和产后妇女中的实用随机对照试验 艾滋病病毒的获取。我们将招收500名孕妇参加产前检查，并跟踪她们12个月 产后。将为参与干预的妇女提供：为参与者和合作伙伴提供HIVST，快速收集PrEP 加强了坚持心理咨询。对PrEP依从性差的妇女将提供差别化护理 家庭PrEP交付模式，使PrEP与临床就诊脱钩。主要结果是PrEP继续 以及产后妇女的依从性，通过替诺福韦二磷酸的药物水平来衡量。我们的目标是：1) Scope-PP干预对孕产期妇女PrEP依从性的影响 在随机对照试验中；2)评估将Scope-PP整合到产前和产后的可接受性和可行性 使用实施研究的综合框架进行护理；以及3)估计增量成本 Scope的有效性--PP与每个艾滋病毒感染和残疾调整后的生命年的护理标准相比，避免了。 这项研究对于提供孕产妇PrEP干预措施以消除艾滋病毒感染和传播至关重要。 南非和更远的地方。

PROJECT SUMMARY: HIV incidence doubles during pregnancy and postpartum period compared with non- pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 76,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drops precipitously in the postpartum period. Our team is made up of experts in epidemiology, behavioral science, health economics and HIV prevention in pregnant women from University of California Los Angeles and the University of Cape Town. Together we have implemented one of the first studies to integrate PrEP into antenatal care in South Africa (“PrEP-PP”; R01MH116771). We propose to test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, HIV self-testing (HIVST) for the participant and her partner(s), and enhanced adherence counseling (with bio-feedback on adherence) combined with home PrEP delivery for women who want to take PrEP but have difficulties adhering. We developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. We will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. We will enroll 500 pregnant women in antenatal care and follow them through 12m postpartum. Women in the intervention will be offered: HIVST for participants & partners, rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP adherence will be offered a differentiated care model of home PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. We aim to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research; and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission in South Africa and beyond.