Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda (NCT06232954) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
Uganda5,600 participantsStarted 2024-06-05
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.