Sickle Pan African Research Consortium NigEria (SPARC-NEt)

镰刀泛非研究联盟 NigEria (SPARC-NEt)

基本信息

批准号：
10414923
负责人：
Obiageli Eunice Nnodu
金额：
$ 25.26万
依托单位：
UNIVERSITY OF ABUJA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-01 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10414923
关键词：
5 year old Address Adopted Advocacy Africa Africa South of the Sahara African Anemia Award Bioinformatics Biological Birth Caring Case Report Form Characteristics Child Chronic Clinical Clinical Data Clinical Research Clinical Sciences Cohort Studies Collaborations Country Data Coordinating Center Databases Demographic and Health Surveys Developed Countries Disease Early Diagnosis Educational Curriculum Ethics Event Fetal Hemoglobin Frequencies Funding Genomic approach Genomics Ghana Goals Guidelines Health Health Care Research Health Personnel Hematology Hemoglobin concentration result High Prevalence Incidence Individual Infection Infrastructure Intervention Knowledge Master&apos s Degree Medicine Mendelian disorder Morbidity - disease rate National Heart, Lung, and Blood Institute Neonatal Screening Newborn Infant Nigeria Outcome Parents Patient Recruitments Patients Peer Review Penicillins Phase Phenotype Policies Politics Population Primary Health Care Prophylactic treatment Publications Quality of life Research Research Training Resources Sampling Sickle Cell Sickle Cell Anemia Site Societies Strategic Planning Structure Support Groups Supporting Cell Supportive care Tanzania Technology Training Translational Research United States National Institutes of Health Universities Work burden of illness clinical phenotype cohort data registry epidemiology study experience follow-up gut microbiome health management health training hydroxyurea implementation study improved mortality recruit sickle cell crisis sickling skills standard care stroke risk success vaso-occlusive crisis working group

项目摘要

Nigeria has the highest prevalence of sickle cell disease (SCD) in the world with an estimated 150,000 babies born annually. Children with SCD in Africa are particularly susceptible to infections, with about 50%-90% dying before five years of age. This burden can be substantially reduced by early diagnosis and supportive care with penicillin prophylaxis, and hydroxyurea (HU) treatment, especially for those at risk of stroke. However, these interventions are yet to be widely implemented in patients with SCD in Nigeria. The Sickle Pan African Research Consortium (SPARCO), with collaborative sites in Ghana, Nigeria and Tanzania was funded by the NIH/ NHLBI in 2017 to establish the infrastructure for future research in SCD. The SPARCO Site in Nigeria is set up at the Centre of Excellence for Sickle Cell Disease Research &Training, University of Abuja (CESRTA). In the first phase of the award, we established the management structure in relation to the Clinical and Data Coordinating Centres and participated actively in consortium working groups’ activities. We obtained and maintained ethical approvals; established a REDCap database under the guidance of the Sickle Africa Data Coordinating Centre (SADaCC); and successfully recruited 4,687 patients across 19 sites using uniform case report forms in collaboration with the Sickle Cell Support Society of Nigeria. (Figure) We delivered specialized training in research and health care management of SCD to 915 health care workers including those in primary health care centres (PHCs). We developed a curriculum for a Master’s degree in Clinical Research and a Postgraduate Diploma in Bioinformatics to address identified gaps. We analyzed preliminary data from the registry and described the clinical phenotypes of SCD in SPARCO Nigeria cohort and conducted an implementation study on newborn. Building on these successes, we are now aiming to sustain, enhance and grow the SCD Network in Africa in order to advance SCD-related epidemiological, translational and clinical research and policy through the Sickle Pan African Research Consortium NigEria (SPARC-NEt) Cohort Study. Our strategy is to increase the SPARC-Net SCD Cohort to 9,000 by: a) recruiting additional 2,000 individuals and bringing in six additional recruitment sites and b) expanding newborn screening to establish a birth cohort of 1000 SCD patients. We will expand, implement, and evaluate the use of the SPARCO Standards of Care (SoC) guidelines for the follow up and management of patients with SCD in the SPARC-NEt Sites and determine the impact of training of, and engagement with, health workers, parents and support groups on the overall health outcomes for individuals with SCD in Nigeria. Additionally, we described three potential implementation and cohort studies that could be adopted by the consortium including a) assess patient characteristics and incidence of clinical events using SPARCO SoC, b) evaluate the impact of HU utilization on clinical and haematological outcomes in patients within the SPARC-Net cohort, and c) using genomic approaches to investigate the association between changes in gut microbiome, HbF levels and frequency of vaso-occlusive crisis in SPARC-Net SCD birth cohort.

尼日利亚是世界上镰状细胞病 (SCD) 患病率最高的国家，估计有 150,000 名婴儿非洲每年出生的 SCD 儿童特别容易受到感染，约有 50%-90% 死亡。五岁之前，通过早期诊断和支持性护理可以大大减轻这种负担。青霉素预防和羟基脲（HU）治疗，特别是对于那些有中风风险的人。尼日利亚的 SCD 患者尚未广泛实施干预措施。联盟 (SPARCO) 在加纳、尼日利亚和坦桑尼亚设有合作地点，由 NIH/NHLBI 资助 2017 年，为 SCD 的未来研究建立基础设施在尼日利亚设立了 SPARCO 站点。阿布贾大学镰状细胞病研究与培训卓越中心 (CESRTA)。在授予阶段，我们建立了与临床和数据协调相关的管理结构我们积极参与联盟工作组的活动，并保持道德规范。在 Sickle Africa 数据协调中心的指导下建立了 REDCap 数据库 (SADaCC)；并使用统一病例报告表成功招募了 19 个地点的 4,687 名患者与尼日利亚镰状细胞支持协会合作（图）我们提供了专门培训。向 915 名卫生保健工作者（包括初级卫生保健人员）提供 SCD 的研究和卫生保健管理我们开发了临床研究硕士学位和研究生课程。生物信息学文凭旨在解决已发现的差距。我们分析了注册表中的初步数据并进行了研究。描述了 SPARCO 尼日利亚队列中 SCD 的临床表型并进行了一项实施研究在这些成功的基础上，我们现在的目标是维持、增强和发展 SCD 网络。非洲，以通过以下方式推进与 SCD 相关的流行病学、转化和临床研究和政策： Sickle 泛非研究联盟 NigEria (SPARC-NEt) 队列研究我们的策略是增加。通过以下方式将 SPARC-Net SCD 队列人数增加到 9,000 人： a) 额外招募 2,000 人并引进 6 名额外人员 b) 扩大新生儿筛查，建立 1000 名 SCD 患者的出生队列。扩展、实施和评估 SPARCO 护理标准 (SoC) 指南的使用，以进行后续跟进和管理 SPARC-NEt 站点中的 SCD 患者，并确定培训和管理的影响与卫生工作者、家长和支持团体就患有此类疾病的个人的整体健康结果进行接触此外，我们还描述了尼日利亚的三项潜在的实施和队列研究。该联盟采用的方法包括：a) 使用以下方法评估患者特征和临床事件的发生率： SPARCO SoC，b) 评估 HU 使用对患者临床和血液学结果的影响 SPARC-Net 队列，以及 c) 使用基因组方法来研究变化之间的关联 SPARC-Net SCD 出生队列中的肠道微生物组、HbF 水平和血管闭塞危机频率。