NCT06232954 Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
| NCT ID | NCT06232954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Africa Power Limited |
| Condition | Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,600 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,600 participants in total. It began in 2024-06-05 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Robert Jones, PhD
PRINCIPAL INVESTIGATOR
Arctech Innovation
Frequently Asked Questions
Who can join the NCT06232954 clinical trial?
This trial is open to participants of all sexes, up to 5 Years, studying Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06232954 currently recruiting?
Yes, NCT06232954 is actively recruiting participants. Contact the research team at robert.jones@arctechinnovation.com for enrollment information.
Where is the NCT06232954 trial being conducted?
This trial is being conducted at Jinja, Uganda.
Who is sponsoring the NCT06232954 clinical trial?
NCT06232954 is sponsored by Africa Power Limited. The principal investigator is Robert Jones, PhD at Arctech Innovation. The trial plans to enroll 5,600 participants.