Preventing Infant Infections with Implementation Science in Malawi

马拉维通过科学实施预防婴儿感染

基本信息

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
项目类别：
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

项目摘要

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.

项目概要我们的计划“马拉维通过实施科学预防婴儿感染”，PRI3SM，将进行 3 解决怀孕和母乳喂养期间孕产妇艾滋病毒感染事件的临床研究（重新）让感染艾滋病毒的孕妇和哺乳期妇女参与我们的传统艾滋病毒护理。研究项目将得到行政核心、实施科学核心和数据支持科学和分析核心。我们自 2002 年以来在马拉维积累的 EMTCT 研究经验；建立了临床研究、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有利地位，可以通过解决母婴传播问题来影响母婴传播目标如下：目标 1.（研究计划）开展 3 个协同研究项目，重点关注弥补 EMTCT 级联中的差距，共同扩大妊娠期艾滋病毒治疗和预防目标 1a 项目 1（妊娠期 PrEP）：评估卡博特韦 (CAB) 妊娠期和哺乳期 PrEP 方案的孕产妇和婴儿安全性。注射 PrEP 比每日口服 PrEP 取得了重大进步7，并且可以显着减少新出现的 PrEP。但 CAB 尚未在孕妇和哺乳期妇女中进行系统研究。建立 CAB 和 TDF/FTC PrEP 用户的国家登记册，这些用户与安全队列一起怀孕接受 PrEP 的孕妇比较妊娠和婴儿结局项目 2。（产后预防包）优化产后艾滋病毒预防，包括 PrEP 的采用和高危哺乳期妇女坚持不懈，以预防原发性艾滋病毒感染和随后的婴儿感染使用新颖的综合任务转移干预策略，包括合作伙伴参与和测试、PrEP、目标 1c. 项目 3 (PAC-Man) 评估小说的影响力和有效性。基于社区的服务模式，“即时护理 (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，并确定有效性和实施衡量结果，包括采用、实施、可持续性和目标 2.（管理核心）建立一个强有力的管理结构高效且有效地实施和整合研究方案，支持实施科学和数据科学和分析核心，并与赞助商卫生部建立现有的丰富合作伙伴关系目标 3.（支持核心）建立强有力的实施。科学、数据科学和分析核心为研究项目提供支持，支持部卫生计划评估，并通过现有的 D43 促进早期研究人员的参与总体而言，我们希望通过以下方面确定成功的实施战略。在马拉维及其他地区实现消除儿童艾滋病毒的潜力。