Malaria Surveillance and Research Studies in Liberia and Guinea-Conakry

利比里亚和几内亚科纳克里的疟疾监测和研究

• 批准号: 10272233
• 负责人: Patrick Duffy
• 金额: $ 1.36万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10272233
• 关键词: Antibody Response; Biological Assay; Blood; Blood specimen; COVID-19; Child; Cross-Sectional Studies; Diagnostic; Diagnostic tests; Disease Outbreaks; Enrollment; Fingers; Frequencies; Guinea; Health; Health care facility; Heel; Helminths; Infant; Infection; Institutional Review Boards; Liberia; Liberian; Malaria; Monitor; National Institute of Allergy and Infectious Disease; Organism; Parasitemia; Parasitic infection; Participant; Performance; Persons; Plasmodium; Plasmodium falciparum; Populations at Risk; Pregnant Women; Prevalence; Protocols documentation; Rennie; Research; Research Ethics; Research Ethics Committees; Schistosoma; Site; Spottings; Strongyloides stercoralis; Training; United States National Institutes of Health; Visit; cohort; i(19); research study; surveillance study

In FY 2018, LMIV began developing two similar protocols for a cross-sectional survey of malaria and helminth prevalence in pregnant women and children at two health care facilities in Liberia (Protocol # 19-I-N007) and one health care facility in Guinea-Conakry (Protocol # 19-I-N141). The primary objective of the studies is to estimate the burden of P. falciparum in these at-risk populations. The secondary objectives are to estimate the frequency of infections due to non-falciparum malaria and to helminths (such as Strongyloides stercoralis, filarial infections, or Schistosoma) in these cohorts. To accomplish these objectives, participants are asked to provide one finger stick or heel prick blood sample which will be used to perform research assays such as rapid diagnostic tests, blood smears, malaria qPCR, and/or helminth-specific antibody responses using dried blood spots. The projects gained approvals from the NIH IRB (both protocols), the Liberian National Research Ethics Board (Protocol # 19-I-N007) and the Guinea National Ethics Committee for Research in Health / Comit National dEthique pour la Recherche en Sant (Protocol # 19-I-N141). In FY2019, Protocol # 19-I-N007 achieved the key milestones of obtaining all necessary regulatory approvals from both the Liberian National Research Ethics Board and the NIAID IRB. The protocol is currently undergoing annual continuing review with the NIH IRB. In addition, a Site Initiation Visit was conducted by the study monitors and study staff was thoroughly trained. Enrollments began in FY 2020 (October 2019 and November 2019 for C.H. Rennie and Duport Road, respectively). Enrollments paused in March 2020 due to the COVID-19 outbreak, and resumed successfully at both sites in August 2020. In FY 2019, Protocol # 19-I-N141 achieved the key milestones of obtaining all necessary regulatory approvals from both the Guinea National Ethics Committee for Research in Health and the NIH IRB. The protocol is currently undergoing annual continuing review with the NIH IRB. In FY 2020, a Site Initiation Visit was conducted by the study monitors and study staff was thoroughly trained. Enrollments began in July 2020. As of 26 August 2020, a total of 794 persons have enrolled in the two sites in Liberia, with 741 being pregnant women and 53 infants. The C.H. Rennie site has enrolled 386 pregnant women and 38 infants, while the Duport Road site has enrolled 354 pregnant women and 15 infants. The single site in Guinea has enrolled 100 participants to date, 74 pregnant women and 24 infants.

2018财年，LMIV开始制定两项类似的方案，对利比里亚两个医疗机构（方案编号19-I-N 007）和几内亚科纳克里一个医疗机构（方案编号19-I-N141）的孕妇和儿童的疟疾和蠕虫流行率进行横断面调查。 这些研究的主要目的是估计这些高危人群中恶性疟原虫的负担。 次要目的是估计这些队列中非恶性疟疾和蠕虫（如粪类圆线虫、丝虫感染或血吸虫）感染的频率。为了实现这些目标，要求受试者提供一份手指针刺或足跟针刺血样，该血样将用于进行研究测定，如快速诊断试验、血涂片、疟疾qPCR和/或使用干血斑的蠕虫特异性抗体应答。 这些项目获得了NIH IRB（两项方案）、利比里亚国家研究伦理委员会（方案编号19-I-N 007）和几内亚国家健康研究伦理委员会/国家卫生研究委员会（方案编号19-I-N141）的批准。 在2019财年，方案19-I-N 007实现了从利比里亚国家研究伦理委员会和NIAID IRB获得所有必要监管批准的关键里程碑。 该方案目前正在接受NIH IRB的年度持续审查。此外，由研究监查员进行研究中心启动访视，并对研究工作人员进行全面培训。 入组于2020财年开始（C.H.于2019年10月及2019年11月）。Rennie和Duport路）。由于COVID-19爆发，于二零二零年三月暂停入组，并于二零二零年八月成功恢复两个中心的入组。 在2019财年，方案19-I-N141实现了从几内亚国家健康研究伦理委员会和NIH IRB获得所有必要监管批准的关键里程碑。 该方案目前正在接受NIH IRB的年度持续审查。 于二零二零财年，研究监查员进行了研究中心启动访视，并对研究人员进行了全面培训。 2020年7月开始招生。 截至2020年8月26日，利比里亚的两个地点共招募了794人，其中741人为孕妇，53人为婴儿。 C.H. Rennie研究中心招募了386名孕妇和38名婴儿，而Duport Road研究中心招募了354名孕妇和15名婴儿。 几内亚的一个研究中心迄今已招募了100名参与者，其中包括74名孕妇和24名婴儿。