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

南非孕妇和产后妇女采用阶梯式护理优化 PrEP 效果 (SCOPE-PP)

• 批准号: 10326755
• 负责人: DVORA JOSEPH DAVEY
• 金额: $ 57.86万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10326755
• 关键词: AIDS prevention; Address; Adherence; Africa South of the Sahara; Behavioral Sciences; Biofeedback; Biological Assay; Breast Feeding; California; Caring; Clinic Visits; Clinical; Collection; Consolidated Framework for Implementation Research; Counseling; Diagnostic Reagent Kits; Diphosphates; Drops; Effectiveness; Enrollment; Epidemiology; Fertility; Frequencies; Guidelines; HIV; HIV Infections; Health Personnel; Health care facility; Healthcare; High Prevalence; High Risk Woman; Home; Human immunodeficiency virus test; Incidence; Infant; Intervention; Interview; Lead; Link; Los Angeles; Measures; Modeling; Monitor; Mothers; Participant; Partner Communications; Patient Self-Report; Pharmaceutical Preparations; Pilot Projects; Play; Policies; Postnatal Care; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Provider; Randomized; Research; Risk; Safety; Services; South Africa; Surveys; Tenofovir; Testing; Time; Translating; Universities; Urine; Vertical Disease Transmission; Visit; Woman; Work; acceptability and feasibility; antenatal; antenatal care; arm; base; comparison intervention; control trial; cost effectiveness; cost-effectiveness evaluation; design; disability-adjusted life years; economic evaluation; efficacy evaluation; empowered; health economics; high risk; improved; incremental cost-effectiveness; innovation; intervention participants; lateral flow assay; male; microcosting; novel; novel strategies; point of care; pre-exposure prophylaxis; pregnant; prevent; preventive intervention; primary outcome; programs; routine care; secondary outcome; self testing; standard of care; testing services; transmission process; treatment arm

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.

项目摘要：与非 - 孕妇强调了针对高危的预防干预措施的迫切需求 怀孕和母乳喂养的妇女。事件产生艾滋病毒感染导致大约三分之一 婴儿艾滋病毒感染。南非预计未来十年将有超过76,000例婴儿艾滋病毒病例；其中三分之一 可以通过消除生物艾滋病毒的获取来预防。预防前预防（PREP）和 母乳喂养可以安全有效地预防艾滋病毒。但是，妊娠的准备时间仍然很低，并且会下降 在产后急剧。我们的团队由流行病学，行为科学专家组成， 来自加利福尼亚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。我们共同实施了第一项研究，以将PREP整合到 南非的产前护理（“ Prep-PP”； R01MH116771）。我们建议测试一种新型策略以优化 在南非的怀孕和产后妇女准备。我们的随机控制试验（RCT）是设计的 解决孕产妇预备使用的关键障碍，并评估信息国家政策的成本效益。 该试验以我们早期的工作为基础，证明了A的可接受性，可行性，安全性和潜在效率 一系列干预措施，包括参与者及其合作伙伴的PREP，HIV自我测试（HIVST）以及 增强的依从性咨询（具有依从性的生物反馈）与家庭准备交付相结合 想要做准备但困难的女性。我们开发并试行了一种新颖的干预措施 标题为“阶梯谨慎”以优化怀孕和产后妇女的预科效果（Scope-PP） 通过减少诊所的访问频率并使妇女的权力来解决每日准备的障碍 坚持准备。我们将在孕妇和产后妇女的务实RCT中评估范围-PP 艾滋病毒收购。我们将招募500名孕妇接受天内护理，并通过12m跟随她们 产后。将提供干预中的妇女：参与者和合作伙伴的HIVST，快速准备收集 通过增强的依从性咨询。准备依从性差的妇女将获得差异化护理 从临床访问到脱键准备的家居准备模型。主要结果是准备继续 以及通过替诺福韦双磷酸药物水平测量的产后妇女的依从性。我们的目标是：1） 评估范围 - PPP干预对孕妇和产后妇女的准备效率的效率 在RCT中； 2）评估将范围-PP整合到产后和产后的可接受性和可行性 使用合并框架进行实施研究的护理； 3）估算增量成本 范围内感染的范围-PP与护理标准的有效性，并避免了残疾调整的生命年。 这项研究至关重要，以告知母校准备干预措施以消除艾滋病毒的收购和传播 南非及以后。