Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Children ≤ 5 Years of Age in Uganda: Study Protocol for a Cluster-randomized Double-blinded Control Trial: The Mossie-GO Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,600
- 试验地点
- 1
- 主要终点
- Malaria prevalence
研究概览
简要总结
A cluster-randomized double-blinded control trial will be conducted in Uganda to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria in children ≤ 5 years of age, as determined by RDT positivity and confirmed by microscopy. The study's secondary objective is to measure the diversionary impact of the intervention on locally unprotected individuals and impact of the intervention on entomological correlates of transmission including vector densities, host seeking behaviour and insecticide resistance. This will be conducted using Centre of Disease Control (CDC) light traps in households, human landing catches and World Health Organisation (WHO) tube tests. Further data collection include household behavioural surveys, air sampling to quantify concentration of transfluthrin present in air, acceptability surveys and intervention safety monitoring.
Recruited households will be monitored across baseline data collection and followed up for 2 disease transmission seasons, for up to 18 months. The devices will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient. Households will be asked to continue using other malaria prevention practices, such as the use of bed nets, as recommended by national policy.
详细描述
The impact of Mossie-GO on malaria cases will be determined through a blinded cluster randomized trial in malaria endemic settings. The device will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient and refill blank discs to maintain study blinding.
The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced. One Mossie-GO device will be provided per household, along with a solar cell unit that will be connected to the Mossie-GO unit and must be placed in direct sunlight to charge the Mossie-Go unit during the day, for use in the evening. Households will be asked to continue using other malaria prevention practices, such as bed nets, as recommended by national policy.
At baseline, Mossie-GO will be distributed at the household level and should be placed in the room of the participant enrolled into the study (child ≤ 5 years of age) while they are sleeping. At the same time a baseline survey will be conducted and children ≤ 5 years of age will be tested for malaria using RDTs and microscopy, to determine baseline malaria prevalence. At this time, household surveys will also be conducted to classify housing structure and collect other variables which may impact the efficacy of the intervention. Following this period, sample size estimates may be adjusted based on malaria prevalence. All recruited households will be monitored at 6-monthly intervals and malaria testing will be done among children ≤ 5 years of age with RDTs and microscopy over a period of up to 18 months. Indoor light traps will be installed in selected households for approximately 3-4 nights in the 6 month intervals and run from 6pm to 7 am to collect mosquitoes indoors, and human landing catches will be conducted. Air sampling will also be conducted alongside mosquito collections to quantify the concentrations of transfluthrin in the air and to help inform entomological and epidemiological outcomes. An acceptability survey will also be conducted at the final data collection time point
The unit of randomization is a cluster, which is defined as a discrete village or area containing a minimum of 100 households. Clusters will be divided into core and buffer zones. Twenty eight clusters will be identified per study arm (treatment and control), thus fifty six clusters will be selected in total. Households within the core zone of clusters will receive the Mossie-GO device (intervention or control). Households within the buffer zones will not receive the Mossie-GO. While all households within the core zone of the cluster are receiving the device, they will not all be sampled for the evaluation of the primary objective (PE). Only a total of 100 eligible, consenting households will be sampled within the core zones. Household surveys will also be conducted in these 100 households. For the evaluation of the secondary outcomes, a subset of houses will be selected. Diversionary impact: 100 households in buffer zone; entomological sampling: 10% of households in core zone; air sampling 1 household every 500m in core zone.
The primary outcome (PE) will be compared between arms using logistic regression with a random effect for study cluster and adverse event data will be collected and summarised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
In exception of the data management personnel responsible for coordinating the manufacture and distribution of the Mossie-GO and independent statistician preparing the Data Safety and Monitoring Board (DSMB) report, all study staff will remain blinded to the household treatment allocation, until the completion of data collection and the locking of the database at the end of the study. Unblinded study staff will have no role in study implementation or outcome assessment.
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cluster level:
- •Number of households > 100
- •Household level:
- •Presence of a child ≤ 5 years of age at point of enrolment in the study
- •Adult head of household agrees to receiving and using the device as per manual instructions
- •Adult head of household agrees to data collection visits and household surveys
- •Children within household sleeps in cluster > 90% of nights during any given month
- •Individual level:
- •≤ 5 years of age when enrolled into the study
- •No plans for extended travel (> 1 month) outside of home during study
- •Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- •Provision of informed consent form (ICF) by the parent(s) or guardian
- •Participants not on regular malaria prophylaxis
排除标准
- •Cluster level:
- •Number of households < 100
- •Household level:
- •Presence of a child > 5 years of age at point of enrolment in the study
- •Adult head of household does not agree to data collection visits and household surveys
- •Children within household sleeps in cluster < 90% of nights during any given month
- •Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
- •Individual level:
- •>5 years of age when enrolled into the study
- •Plans for extended travel (> 1 month) outside of home during study
- •Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- •No provision of ICF signed by the parent(s) or guardian
- •Participants on regular malaria prophylaxis
结局指标
主要结局
Malaria prevalence
时间窗: 18 months
Malaria prevalence among children ≤ 5 years of age as determined by Rapid Diagnostic Test (RDT) positivity and confirmed by microscopy.
次要结局
- Assessment of the diversionary effect of spatial repellent in the buffer zone using RDT and microscopy(18 months)
- Household surveys(18 months)
- Safety of intervention(18 months)
- Entomological correlates of transmission(18 months)
- Air sampling(18 months)
- Acceptability survey(18 months)