Actively Recruiting
Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
Led by Africa Power Limited · Updated on 2024-06-21
5600
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
A
Africa Power Limited
Lead Sponsor
M
Malaria Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cluster area has more than 100 households
- Household includes a child aged 5 years or younger at enrollment
- Adult head of household agrees to receive and use the device as instructed
- Adult head of household agrees to data collection visits and household surveys
- Children in the household sleep in the cluster area more than 90% of nights each month
- Child is 5 years old or younger at enrollment
- No plans for extended travel away from home for more than 1 month during the study
- Not participating in another clinical trial involving vaccines, drugs, devices, or medical procedures
- Parent or guardian provides signed informed consent
- Child is not on regular malaria prophylaxis
You will not qualify if you...
- Cluster area has fewer than 100 households
- Household includes a child older than 5 years at enrollment
- Adult head of household does not agree to data collection visits and household surveys
- Children in the household sleep in the cluster area less than 90% of nights each month
- Household is considered a security risk by study staff (e.g., site of drug sales, hostile residents)
- Child is older than 5 years at enrollment
- Plans for extended travel away from home for more than 1 month during the study
- Participating or planning to participate in another clinical trial involving vaccines, drugs, devices, or medical procedures
- No signed informed consent from parent or guardian
- Child is on regular malaria prophylaxis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Malaria Consortium
Jinja, Uganda
Actively Recruiting
Research Team
R
Robert Jones, PhD
CONTACT
J
Jane Achan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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