Burnet Institute, Melbourne, Australia.
Burnet Institute, Yangon, Myanmar.
BMC Infect Dis. 2018 Dec 14;18(1):663. doi: 10.1186/s12879-018-3566-y.
To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, and sustainable preventive measures, including vector control. Topical repellents are an intervention that can be used to target residual malaria transmission not covered by long lasting insecticide nets and indoor residual spraying. Although there is strong evidence that topical repellents protect against mosquito bites, evidence is not well established for the effectiveness of repellents distributed as part of malaria control activities in protecting against episodes of malaria. A common approach to deliver malaria services is to assign Village Health Volunteers (VHVs) to villages, particularly where limited or no services exist. The proposed trial aims to provide evidence for the effectiveness of repellent distributed through VHVs in reducing malaria.
The study is an open stepped-wedge cluster-randomised controlled trial randomised at the village level. Using this approach, repellent (N,N-diethyl-benzamide - 12% w/w, cream) is distributed by VHVs in villages sequentially throughout the malaria transmission season. Villages will be grouped into blocks, with blocks transitioned monthly from control (no repellent) to intervention states (to receive repellent) across 14 monthly intervals in random order). This follows a 4-week baseline period where all villages do not receive repellent. The primary endpoint is defined as the number of individuals positive for Plasmodium falciparum and Plasmodium vivax infections diagnosed by a rapid diagnostic test. Secondary endpoints include symptomatic malaria, Polymerase Chain Reaction (PCR)-detectable Plasmodium spp. infections, molecular markers of drug resistance and antibodies specific for Plasmodium spp. parasites.
This study has been approved by relevant institutional ethics committees in Myanmar and Australia. Results will be disseminated through workshops, conferences and peer-reviewed publications. Findings will contribute to a better understanding of the optimal distribution mechanisms of repellent, context specific effectiveness and inform policy makers and implementers of malaria elimination programs in the GMS.
Australian and New Zealand Clinical Trials Registry ( ACTRN12616001434482 ). Retrospectively registered 14th October 2016.
为了应对大湄公河次区域（GMS）出现的新的抗药性问题，世界卫生组织和 GMS 国家承诺到 2030 年消除该地区的疟疾。总体方法包括提供普遍获得疟疾诊断和治疗的机会，以及可持续的预防措施，包括病媒控制。局部驱虫剂是一种干预措施，可用于针对长效杀虫剂蚊帐和室内残留喷洒无法覆盖的残留疟疾传播。虽然有强有力的证据表明局部驱虫剂可以防止蚊虫叮咬，但驱虫剂在疟疾控制活动中分发以防止疟疾发作方面的有效性证据并不充分。提供疟疾服务的一种常见方法是向村庄分配乡村卫生志愿者（VHV），特别是在服务有限或不存在的地方。拟议的试验旨在提供通过 VHV 分发驱虫剂以减少疟疾的有效性证据。
该研究是一项开放的分步楔形群随机对照试验，在村级进行随机化。使用这种方法，驱虫剂（N，N-二乙基苯甲酰胺-12％w/w，霜剂）由 VHV 按顺序在整个疟疾传播季节向村庄分发。村庄将按块分组，使用块在 14 个每月间隔内以随机顺序逐月从对照（无驱虫剂）过渡到干预状态（接受驱虫剂）。这是在 4 周的基线期之后进行的，在基线期内，所有村庄都不接受驱虫剂。主要终点定义为通过快速诊断测试诊断为恶性疟原虫和间日疟原虫感染阳性的个体数量。次要终点包括有症状的疟疾、聚合酶链反应（PCR）检测到的疟原虫感染、药物耐药的分子标志物以及针对疟原虫寄生虫的特异性抗体。
这项研究已获得缅甸和澳大利亚相关机构伦理委员会的批准。结果将通过研讨会、会议和同行评议出版物进行传播。研究结果将有助于更好地了解驱虫剂的最佳分配机制、具体背景下的有效性，并为 GMS 的抗疟消除计划的决策者和执行者提供信息。
澳大利亚和新西兰临床试验注册中心（ACTRN12616001434482）。于 2016 年 10 月 14 日进行回顾性注册。
