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RECRUITINGINTERVENTIONAL

Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form (ICF) by the parent(s) or guardian Participants not on regular malaria prophylaxis Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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

Treatments Being Tested

DEVICE

Mossie-Go containing treated transfluthrin disc

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.

DEVICE

Mossie-Go containing untreated blank disc

The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with a blank untreated disc. These discs sit above a fan that is powered by a small motor charged by solar energy. The device containing the untreated disc is not expected to prevent mosquito bites. The discs will still be replaced monthly for blinding purposes.

Locations (1)

Malaria Consortium
Jinja, Uganda