Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya.
Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya.
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DOI：
10.1136/bmjopen-2015-008950
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发表时间：
2015-10-19
期刊：
影响因子：
2.9
通讯作者：
Anderson RM
中科院分区：
文献类型：
--
作者：
Brooker SJ;Mwandawiro CS;Halliday KE;Njenga SM;Mcharo C;Gichuki PM;Wasunna B;Kihara JH;Njomo D;Alusala D;Chiguzo A;Turner HC;Teti C;Gwayi-Chore C;Nikolay B;Truscott JE;Hollingsworth TD;Balabanova D;Griffiths UK;Freeman MC;Allen E;Pullan RL;Anderson RM
近年来，人们前所未有地重视控制被忽视的热带疾病，包括土源性蠕虫（STH）。 STH 控制的支柱是学校驱虫 (SBD)，但数学模型表明，在传播率非常低的情况下，SBD 不太可能中断传播，因此需要新的治疗策略。本研究旨在回答以下问题：是否有可能中断 STH 的传播，如果可以，实现这一目标的最具成本效益的治疗策略和给药系统是什么？肯尼亚正在对比环境中实施两项整群随机试验。这些干预措施是作为国家 SBD 计划的一部分，每年向学龄前和学龄儿童提供大规模驱虫治疗，或由社区卫生工作者向整个社区提供。研究组的分配是按集群进行的，使用公共卫生服务中使用的预定义单位——称为社区单位（CU）。 CU 被随机分配到三组之一：接受 (1) 年度 SBD； （2）每年进行社区驱虫（CBD）；或 (3) 每两年一次的 CBD。主要结果指标是钩虫感染的患病率，通过四项横断面调查进行评估。次要结果是蛔虫和鞭虫的流行率、物种感染的强度和治疗覆盖率。将评估成本和成本效益。在参与者的随机子样本中，将纵向评估蠕虫负担和未受精卵的比例。使用半结构化访谈、焦点小组讨论和利益相关者分析的嵌套过程评估将调查每个交付系统的社区可接受性、可行性和规模。研究方案已经过肯尼亚医学研究所伦理委员会和国家伦理审查委员会以及伦敦卫生和热带医学学院的审查和批准。该研究有一个专门的网站。 NCT02397772。
In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision—termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a dedicated web site. NCT02397772.