Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 collectio