Preventing Infant Infections with Implementation Science in Malawi

项目摘要 我们的计划，“预防婴儿感染与实施科学在马拉维”，PRI 3SM，将进行3 开展临床研究，处理怀孕和哺乳期间孕产妇感染艾滋病毒的事件， （重新）让感染艾滋病毒的孕妇和哺乳期妇女参与传统的艾滋病毒护理。我们 研究项目将由行政核心，实施科学核心和数据支持。 科学与分析核心自2002年以来，我们在马拉维的EMTCT研究方面积累了经验; 建立当地合作伙伴关系;临床研究、流行病学、实施 和行为科学;我们的协同项目使我们处于一个极好的位置，通过解决 目标：目标1。（研究计划）开展3个协同研究项目，重点是 解决消除母婴传播级联中的差距，共同扩大怀孕期间的艾滋病毒治疗和预防 目的1a.项目1（PrEP在怀孕期间） PrEP方案在妊娠和母乳喂养中的母婴安全性。Cabotegravir（CAB） 注射PrEP代表了每日口服PrEP的实质性进步7，可以大大减少新的 产妇感染。但CAB在妊娠期和哺乳期妇女中尚未进行系统研究。我们将 建立CAB和TDF/FTC PrEP使用者的国家登记册，这些使用者与安全队列一起怀孕 接受PrEP的孕妇比较怀孕和婴儿的结果。目标1b。计划2 （产后预防包）优化产后艾滋病毒预防，包括PrEP摄入和 在高危哺乳期妇女中持续开展预防艾滋病毒初次感染和随后的婴儿感染的活动 使用一种新的综合任务转移干预策略，包括伙伴参与和测试，PrEP， 和社区外展。目标1c。项目3（吃豆人）评估小说的影响力和有效性 基于社区的服务模式，即“护理点（POC）主动病例发现和管理”（或 PAC-Man）模型，以识别和测试通过常规设施测试遗漏的婴儿，并确定 有效性和衡量实施成果，包括采用、实施、可持续性和 确定的每个儿童艾滋病毒病例的成本。AIM 2.（管理核心）创建一个强大的行政结构， 有效地实施和整合研究协议，支持实施科学， 数据科学和分析核心，并培养与赞助商卫生部现有的丰富合作伙伴关系 和艾滋病毒PEPFAR执行伙伴。目标3：（支持核心）建立强有力的实施 科学和数据科学和分析核心，以提供支持的研究项目，支持部 健康计划评估，并通过现有的D43促进早期研究者的参与 能力建设方案。总的来说，我们期望确定成功的实施战略， 在马拉维及其他地区消除儿童艾滋病毒的潜力。

Project Summary Our program, “Preventing Infant Infection with Implementation Science in Malawi”, PRI3SM, will conduct 3 clinical studies to address incident maternal HIV infections during pregnancy and breastfeeding and (re)engage pregnant and breastfeeding women with HIV frequently missed by traditional HIV care. Our research projects will be supported by an Administrative Core, an Implementation Science Core and a Data Science and Analytical Core. Our accumulated experience with EMTCT research in Malawi since 2002; established local partnerships; cross disciplinary expertise in clinical research, epidemiology, implementation and behavior science; and our synergistic projects put us in a superb position to impact MTCT by addressing the following aims: Aim 1. (Research Program) Conduct 3 synergistic research projects focused on addressing gaps in the EMTCT cascade that collectively expand HIV treatment and prevention in pregnancy and postpartum to avert maternal and infant infections.Aim 1a. Project 1 (PrEP in Pregnancy) To evaluate maternal and infant safety of PrEP regimens in pregnancy and breastfeeding. Cabotegravir (CAB) injectable PrEP represents a substantial advance over daily oral PrEP7 and could dramatically reduce new maternal infections. But CAB has not been systematically studied in pregnant and lactating women. We will establish a national registry of CAB and TDF/FTC PrEP users who become pregnant alongside a safety cohort of pregnant women receiving PrEP to compare pregnancy and infant outcomes. Aim 1b. Project 2 (Postpartum Prevention Package) To optimize post-partum HIV prevention including PrEP uptake and persistence among at-risk lactating women to prevent primary HIV infection and subsequent infant infection using a novel integrated task-shifting intervention strategy including partner engagement and testing, PrEP, and community outreach. Aim 1c. Project 3 (PAC-Man) To evaluate reach and effectiveness of a novel community-based service model, the “Point-of-care (POC) Active Case-finding & Management” (or PAC-Man) model to identify and test infants missed through routine facility testing and determine effectiveness and measure implementation outcomes including, adoption, implementation, sustainability, and cost per pediatric HIV case identified. AIM 2. (Admin Core) Create a robust administrative structure to implement and integrate research protocols efficiently and effectively, support the Implementation Science and Data Science and Analytical Cores, and nurture existing rich partnerships with the sponsor, Ministry of Health and HIV PEPFAR implementing partners. Aim 3. (Support Cores) To establish robust Implementation Science and Data Science and Analytical Cores to provide support to the study projects, support Ministry of Health program evaluation, and facilitate engagement of early-stage investigators through existing D43 capacity building programs. Broadly, we expect to identify successful implementation strategies with the potential to achieve elimination of pediatric HIV in Malawi and beyond.