有效性-实施混合研究方案,评估乌干达卡拉莫贾地区5个县实施季节性疟疾化学预防的有效性和化学预防效果

R. Kajubi, J. Ainsworth, K. Baker, S. Richardson, C. Bonnington, C. Rassi, Jane Achan, Godfrey Magumba, Denis Rubahika, Jane Nabakooza, J. Tibenderana, A. Nuwa, J. Opigo
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引用次数: 0

摘要

背景:世界卫生组织(世卫组织)建议对生活在疟疾传播高度季节性地区的3至59个月儿童使用磺胺多辛-乙胺嘧啶和阿莫地喹进行季节性疟疾化学预防(SMC)。然而,由于耐药标记物的广泛流行,SMC尚未在东非和南部非洲大规模实施。在乌干达进行的一项初步研究表明,在Karamoja地区,SMC结合SPAQ是可行的、可接受的,并且对符合条件的儿童具有预防疟疾的作用。尽管如此,由于寄生虫耐药性威胁持续存在,探索替代方案是有必要的。目的:在乌干达卡拉莫贾地区疟疾季节性传播较强的3-59月龄儿童中,检测SMC联合DP或SPAQ (DP-SMC & SPAQ-SMC)的有效性、化学预防效果以及DP与SPAQ的安全性和耐受性。方法:采用II型混合有效性-实施研究设计,包括四个组成部分:1)采用被动监测的聚类随机对照试验(cRCT),同时使用SPAQ和DP建立儿童疟疾确诊病例;2a)一项前瞻性队列研究,以确定SPAQ和DP的化学预防功效(如果SPAQ或DP清除亚专利感染并提供28天的新感染保护),以及药物浓度和/或耐药性是否影响清除和预防感染的能力;2b)一项检查3 - 6个月儿童DP药代动力学的亚研究;3)对研究区和标准干预区3 - 59月龄儿童进行耐药标志物研究,测量耐药标志物的流行率随时间的变化;4)过程评价。讨论:本研究在收集实施信息的同时评估临床干预对相关结果的影响。结论:本研究将为高负担国家的疟疾政策提供信息,并有助于疟疾控制的进展。
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A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda
Background: The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist. Objective: The study aims to test the effectiveness of SMC with DP or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal. Methods: A Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent  infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to <6 months; 3) a resistance markers study in children 3–59 months in the research districts plus the standard intervention districts to measure changes in resistance marker prevalence over time and finally; 4) a process evaluation. Discussion: This study evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. Conclusion: This study will inform malaria policy in high-burden countries and contribute to progress in malaria control.
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来源期刊
Gates Open Research
Gates Open Research Immunology and Microbiology-Immunology and Microbiology (miscellaneous)
CiteScore
3.60
自引率
0.00%
发文量
90
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