Research Project 2

研究项目2

• 批准号: 10738443
• 负责人: Juliet Iwelunmor
• 金额: $ 23.38万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10738443
• 关键词: Adult; Africa; African; Automobile Driving; Birth; Cancer Control; Caring; Cessation of life; Child; China; Chronic Hepatitis B; Clinic; Clinical; Communities; Community Developments; Community Health Aides; Consolidated Framework for Implementation Research; Country; Creativeness; Data; Decentralization; Dose; Elements; Engineering; Equity; Evaluation; Face; Guidelines; HBV Liver Cancer; Health Services; Hepatitis; Hepatitis B; Hepatitis B Infection; Hepatitis B Transmission; Hepatitis B Vaccines; Hepatitis B Virus; Home; Hospitals; Hour; Hybrids; Immunity; Immunization; Individual; Infant; Intervention; Liver diseases; Malignant neoplasm of liver; Measures; Medicine; Mothers; National Cancer Institute; Newborn Infant; Nigeria; Nigerian; Persons; Policies; Population; Pregnant Women; Prevention; Primary carcinoma of the liver cells; Printing; Protocols documentation; Randomized, Controlled Trials; Recommendation; Records; Request for Applications; Research; Research Methodology; Research Project Grants; Risk; Services; Site; Time; Training; United States National Academy of Sciences; United States National Institutes of Health; Vaccination; Vaccines; Vertical Disease Transmission; chronic infection; cohort; community clinic; community engagement; concept mapping; crowdsourcing; effectiveness evaluation; effectiveness/implementation design; emerging adult; implementation outcomes; implementation process; implementation research; implementation science; implementation strategy; infant infection; innovation; low and middle-income countries; mathematical model; neonatal infection; post implementation; preference; primary outcome; secondary outcome; standard care; testing uptake; uptake; vaccine acceptance; vaccine delivery

Every hour, over 150 people die of hepatitis-related liver diseases in African countries like Nigeria, including hepatocellular carcinoma (HCC) and other liver cancers. Much of this death is attributable to the hepatitis B virus (HBV). A hepatitis B birth dose (HepB-BD) vaccine initiated within 24 hours of birth, followed by three additional pentavalent HBV vaccines (at six, 10, and 14 weeks after birth), provide durable immunity, substantially decreasing the risk of HBV and liver cancer. Nigerian national guidelines recommend HepB-BD vaccination for all newborns and provides them for free as part of the national immunization protocol, yet uptake is suboptimal, highlighting the need for implementation science research to develop locally relevant strategies to increase HepB-BD vaccine uptake. We propose a crowdsourcing approach to enhance timely coverage of HepB-BD vaccination in Nigeria. Crowdsourcing has a group of people solve all or part of a problem, then implement selected solutions. Our team used crowdsourcing to develop messages promoting HBV testing uptake, inform global hepatitis guidelines, and enhance hepatitis community engagement in low and middle-income countries (LMICs). Our study will focus on developing and implementing strategies to increase HepB-BD vaccination at community clinics, home births, and other sites outside of hospitals where most pregnant women receive care. The Consolidated Framework for Implementation Science Research (CFIR) and concept mapping will guide our evaluation of factors influencing uptake and sustainment. Our specific aims are: 1) To determine pregnant women's preferences on HepB-BD vaccination using community-engaged crowdsourcing research and finalize an implementation strategy to increase HepB-BD vaccination; 2) To determine the effectiveness of a finalized crowdsourced HepB-BD vaccination intervention among a cohort of pregnant women using a community-based clinic-level cluster RCT. Trained community health workers will implement the final intervention in a cluster randomized control trial of the crowdsourced intervention versus standard care (i.e. printed guidelines) among a cohort of 720 dyads (pregnant women and newborns) at 36 community-based clinics (n=1440); and 3) To use mixed methods research to determine multi-level factors that influence uptake and sustainment of crowdsourced HepB-BD vaccination over time. Primary outcome is HepB-BD vaccination ascertained by clinic records. Secondary outcome is service sustainment at the community-based clinic level, defined here as the percent sustainment of core elements of the final campaign measured 12 months after the trial, with sustained benefits and capacity for implementation at each community-based clinic. Our study is responsive to the U54 request for applications for global implementation science for equitable cancer control and and the strategic priorities of the National Cancer Institute. This study will provide a unique opportunity to expand HBV vaccine coverage, driving equitable implementation science research in settings traditionally under-represented in implementation science.

每小时，超过150人死于尼日利亚等非洲国家与肝炎有关的肝病，包括 肝细胞癌（HCC）和其他肝癌。这种死亡的大部分归因于乙型肝炎 病毒（HBV）。乙型肝炎B出生剂量（HEPB-BD）疫苗在出生后24小时内开始，然后是三个 额外的五价HBV疫苗（出生后的六个，10和14周）提供持久的免疫力， 大大降低了HBV和肝癌的风险。尼日利亚国家准则建议HEPB-BD 为所有新生儿的疫苗接种，并作为国家免疫协议的一部分免费提供，但 吸收是次优的，强调了实施科学研究的需求，以发展本地相关 增加HEPB-BD疫苗摄取的策略。我们提出了一种众包方法来增强及时 尼日利亚HEPB-BD疫苗接种的覆盖范围。众包有一群人解决所有问题 问题，然后实现选定的解决方案。我们的团队使用众包来开发促进信息 HBV测试摄取，为全球肝炎指南提供信息，并增强肝炎社区的参与度。 和中等收入国家（LMIC）。我们的研究将着重于制定和实施策略 在社区诊所，家庭分娩和医院外的其他地点增加HEPB-BD疫苗接种 大多数孕妇接受护理。实施科学研究的合并框架 （CFIR）和概念映射将指导我们对影响吸收和维持的因素的评估。 我们的具体目的是：1）确定使用HEPB-BD疫苗接种的孕妇的偏好 社区参与的众包研究并最终确定了增加HEPB-BD的实施策略 疫苗接种； 2）确定最终众包HEPB-BD疫苗接种干预的有效性 在使用基于社区的诊所级别RCT的一群孕妇中。受过训练的社区 卫生工作者将在众包的群集随机控制试验中实施最终干预 干预与标准护理（即印刷指南）在720个二元组（孕妇和 新生儿）在36个社区诊所（n = 1440）； 3）使用混合方法研究来确定 随着时间的推移，众包HEPB-BD疫苗接种的摄取和维持的多层次因素。 主要结果是通过临床记录确定HEPB-BD疫苗接种。次要结果是服务 在基于社区的诊所的维持，此处定义为核心要素的维持百分比 审判后12个月测得的最后一项竞选活动，具有持续的利益和实施能力 在每个基于社区的诊所。我们的研究响应U54的全球申请请求 实施公平癌症控制和国家癌症的战略重点的科学 研究所。这项研究将为扩大HBV疫苗覆盖范围提供独特的机会，推动公平 传统上，实施科学在实施科学方面的实施科学研究。