Research Project 2

研究项目2

基本信息

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
项目类别：
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

项目摘要

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.

在尼日利亚等非洲国家，每小时有超过 150 人死于与肝炎相关的肝病，其中包括肝细胞癌（HCC）和其他肝癌。大部分死亡归因于乙型肝炎病毒（乙型肝炎病毒）。出生后 24 小时内接种乙型肝炎出生剂量 (HepB-BD) 疫苗，然后接种三剂额外的五价乙肝疫苗（出生后 6 周、10 周和 14 周），提供持久的免疫力，显着降低乙型肝炎和肝癌的风险。尼日利亚国家指南推荐 HepB-BD 作为国家免疫方案的一部分，为所有新生儿免费提供疫苗接种，但利用率不高，突出表明需要开展科学研究以开发与当地相关的成果增加 HepB-BD 疫苗接种率的策略。我们提出了一种众包方法来增强及时性尼日利亚 HepB-BD 疫苗接种覆盖率。众包让一群人解决全部或部分问题问题，然后实施选定的解决方案。我们的团队使用众包来开发消息推广乙肝病毒检测的普及，为全球肝炎指南提供信息，并提高低水平肝炎社区的参与度和中等收入国家（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会得到护理。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进行评估。我们的具体目标是： 1) 使用以下方法确定孕妇对 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 疫苗接种干预措施的有效性在一组孕妇中使用基于社区的诊所级随机对照试验进行研究。训练有素的社区卫生工作者将在众包的整群随机对照试验中实施最终干预措施在 720 名双人组（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，影响众包 HepB-BD 疫苗接种和维持的多层次因素。主要结果是根据临床记录确定 HepB-BD 疫苗接种情况。次要成果是服务社区诊所层面的维持，此处定义为核心要素的维持百分比最终活动在试验后 12 个月进行测量，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 U54 申请全球研究的请求公平癌症控制的实施科学和国家癌症战略重点研究所。这项研究将为扩大乙肝疫苗覆盖范围、推动公平实施科学研究传统上在实施科学中代表性不足。