Preventing Infant Infections with Implementation Science in Malawi

项目摘要 我们的项目，“在马拉维用实施科学预防婴儿感染”，PRI3SM，将进行3 针对孕妇在怀孕和哺乳期间感染艾滋病毒的临床研究 (重新)让感染艾滋病毒的孕妇和哺乳期妇女参与传统艾滋病毒护理经常遗漏的艾滋病毒感染问题。我们的 研究项目将由一个行政核心、一个实施科学核心和一个数据提供支持 科学与分析核心。我们自2002年以来在马拉维进行的紧急母婴传播研究积累的经验； 建立当地伙伴关系；临床研究、流行病学、实施方面的跨学科专业知识 和行为科学；我们的协同项目使我们处于极好的地位，通过解决以下问题来影响母婴传播 目标1.(研究计划)开展3个协同研究项目，重点是 解决共同扩大孕期艾滋病毒治疗和预防的母婴传播级联中的差距 和产后，以避免母婴感染。项目1(孕期PrEP)评估 孕期和哺乳期PrEP方案的母婴安全性。卡波替格韦(CAB) 可注射PrEP比每日口服PrEP7有了实质性的进步，可以显著减少新的 母体感染。但CAB在孕妇和哺乳期妇女中还没有得到系统的研究。我们会 建立与安全队列一起怀孕的CAB和TDF/FTC PrEP使用者的全国登记 接受PrEP的孕妇的比例，以比较妊娠和婴儿的结局。目标1b。项目2 (产后预防一揽子计划)优化产后艾滋病毒预防，包括PrEP摄取和 高危哺乳期妇女坚持预防初次艾滋病毒感染和随后的婴儿感染 使用新的集成任务转移干预策略，包括合作伙伴参与和测试、PrEP、 和社区外展。目标1c。项目3(PAC-Man)，以评估小说的覆盖范围和有效性 以社区为基础的服务模式，即“护理点(POC)主动病例发现和管理”(或 PAC-Man)模型，用于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 已确定的每个儿童艾滋病毒病例的成本。目标2.(管理核心)创建强大的管理结构，以 高效、有效地实施和整合研究协议，支持实施科学和 数据科学和分析核心，并培育与赞助商卫生部现有的丰富伙伴关系 和艾滋病毒防治艾滋病紧急救援计划的实施伙伴。目标3.(支助核心)建立强有力的执行 科学与数据科学和分析核心为研究项目提供支持，支持该部 健康计划评估，并通过现有的D43促进早期调查人员的参与 能力建设方案。大体上，我们期望通过 在马拉维及其他地区实现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.