Preventing Infant Infections with Implementation Science in Malawi

马拉维通过科学实施预防婴儿感染

• 批准号: 10701191
• 负责人: MINA CHRISTINE HOSSEINIPOUR
• 金额: $ 121.84万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701191
• 关键词: AIDS prevention; Address; Adoption; Behavior; Breast Feeding; Caring; Child; Child Care; Childhood; Clinic; Clinic Visits; Clinical Research; Clinical Sciences; Communities; Community Outreach; Country; Data Analytics; Data Science; Development; Diagnosis; Drops; Early Diagnosis; Early treatment; Effectiveness; Ensure; Epidemiology; Foundations; Frequencies; Goals; HIV; HIV Infections; Health; Human immunodeficiency virus test; Immunization; Infant; Infection; Injectable; Intervention; Lactation; Malawi; Modeling; Mother-to-child HIV transmission; Mothers; National Institute of Child Health and Human Development; Oral; Personal Satisfaction; Policies; Population; Positioning Attribute; Postpartum Period; Pregnancy; Pregnancy Outcome; Pregnant Women; Prevention; Program Evaluation; Prophylactic treatment; Protocols documentation; Regimen; Registries; Request for Applications; Research; Research Personnel; Research Project Grants; Risk; Safety; Science; Service delivery model; Services; Structure; Testing; United States National Institutes of Health; Vertical Disease Transmission; Viral; Viral Load result; Woman; antenatal; antiretroviral therapy; case finding; cohort; community based service; cost; effectiveness evaluation; effectiveness measure; effectiveness outcome; experience; future implementation; high risk; implementation measures; implementation outcomes; implementation science; implementation strategy; infant infection; infant outcome; innovation; novel; pediatric human immunodeficiency virus; pediatric human immunodeficiency virus infection; point of care; pre-exposure prophylaxis; pregnant; prevent; programs; seroconversion; tool; transmission process; treatment program; uptake

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.

项目摘要 我们的计划“防止在马拉维实施科学的婴儿感染”，PRI3SM，将进行3 临床研究，以解决怀孕和母乳喂养期间发生的母校艾滋病毒感染和 （重新）让孕妇和母乳喂养艾滋病毒经常因传统艾滋病毒护理而错过。我们的 研究项目将得到行政核心，实施科学核心和数据的支持 科学和分析核心。自2002年以来，我们在马拉维的EMTCT研究中积累的经验； 建立的地方伙伴关系；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位置，可以通过解决MTCT来影响MTCT 以下目的：目标1。（研究计划）进行3个协同研究项目的重点 解决EMTCT级联的差距，该漏洞集体扩大了怀孕的HIV治疗和预防 并产后避免材料和婴儿感染。IAM1A。项目1（怀孕准备）评估 预科和母乳喂养中准备方案的母亲和婴儿安全。 cabotegravir（驾驶室） 注射式准备代表了每日口服Prep7的实质性进步，并且可能会大大减少新的 母体感染。但是CAB并未在怀孕和哺乳期的妇女中系统地研究。我们将 建立与安全队列一起怀孕的CAB和TDF/FTC准备用户的国家注册表 接受预备的孕妇比较怀孕和婴儿结局。目标1B。项目2 （预防产后预防措施）优化预防产后艾滋病毒的预防措施，包括摄取和 高风险哺乳期妇女的持久性预防原发性HIV感染和随后的婴儿感染 使用一种新颖的集成任务转移干预策略，包括合作伙伴参与和测试，准备， 和社区宣传。 AIM 1C。项目3（PAC-MAN）评估小说的覆盖范围和有效性 基于社区的服务模型，“现场（POC）主动案例找到与管理”（或 PAC-MAN）模型以通过常规设施测试识别和测试婴儿并确定 有效性和衡量实施成果，包括采用，实施，可持续性和 确定的每小儿艾滋病毒病例的费用。目标2。（管理员核）创建一个强大的管理结构 有效，有效地实施和集成研究协议，支持实施科学，并 数据科学和分析核心，并与卫生部的赞助商一起护理现有的丰富合作伙伴关系 和HIV PEPFAR实施合作伙伴。目标3。（支持核心）建立强大的实施 科学和数据科学和分析核心，为研究项目提供支持，支持部 健康计划评估，并通过现有D43促进早期研究人员的参与 能力建设计划。从广义上讲，我们希望与 消除马拉维及其他地区的小儿艾滋病毒的潜力。