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.

在非洲国家，如尼日利亚，每小时有150多人死于肝炎相关的肝病， 肝细胞癌（HCC）和其它肝癌。大部分的死亡是由于B型肝炎 病毒（HBV）。出生后24小时内开始接种出生剂量的B肝炎疫苗（HepB-BD），随后接种3次 额外的五价HBV疫苗（出生后6周、10周和14周），提供持久的免疫力， 大大降低HBV和肝癌的风险。尼日利亚国家指南推荐HepB-BD 为所有新生儿接种疫苗，并作为国家免疫方案的一部分免费提供，但 吸收是次优的，突出需要实施科学研究，以发展当地相关的 增加HepB-BD疫苗摄取的策略。我们提出了一个众包的方法，以提高及时 尼日利亚HepB-BD疫苗接种覆盖率。众包有一组人解决所有或部分的一个 问题，然后实施选定的解决方案。我们的团队使用众包来开发信息， HBV检测摄取，为全球肝炎指南提供信息，并加强肝炎社区参与低 中等收入国家（LMIC）。我们的研究将侧重于制定和实施战略， 在社区诊所、家庭分娩和医院以外的其他场所增加HepB-BD疫苗接种， 大多数孕妇都能得到护理。实施科学研究的综合框架 （CFIR）和概念图将指导我们对影响吸收和维持的因素的评估。 我们的具体目标是：1）确定孕妇对HepB-BD疫苗接种的偏好， 社区参与的众包研究，并最终确定实施战略，以增加HepB-BD 2）确定最终众包HepB-BD疫苗接种干预措施的有效性 在一组孕妇中使用基于社区的临床水平的随机对照试验。培训的社区 卫生工作者将在一项众包的随机对照试验中实施最终干预， 干预与标准护理（即印刷指南）在720对夫妇（孕妇和 新生儿）在36个社区诊所（n=1440）;和3）使用混合方法研究，以确定 随着时间的推移，影响众包HepB-BD疫苗接种的吸收和维持的多水平因素。 主要结局是通过临床记录确定的HepB-BD疫苗接种。次要结局是服务 社区诊所一级的维持，此处定义为 最后一次活动是在试验后12个月进行的，具有持续的效益和实施能力 在每个社区诊所。我们的研究是响应U 54申请全球 实施科学促进公平的癌症控制和国家癌症战略优先事项 院这项研究将提供一个独特的机会，扩大乙肝疫苗的覆盖面，推动公平 在传统上在实施科学中代表性不足的环境中进行实施科学研究。