Using a spatial repellent to reduce malaria in young children 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
This study is testing whether a new device that repels mosquitoes can help reduce malaria cases in young children under five in Uganda.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5600 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | Africa Power Limited Industry-sponsored |
| Locations | 1 site (Jinja) |
| Trial ID | NCT06232954 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the Mossie-GO device, which uses transfluthrin, a spatial repellent, to reduce malaria prevalence among children aged five and under in Uganda. The study employs a cluster-randomized, double-blinded design, where households are assigned to either receive the active device or a placebo. Data will be collected on malaria cases, mosquito behavior, and the device's safety and acceptability through various methods, including household surveys and entomological assessments. The aim is to quantify the protective efficacy of the device in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are households with children aged five years or younger living in malaria-endemic areas of Uganda.
Not a fit: Patients who do not have children under five years of age or who are currently on malaria prophylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce malaria cases in young children, improving health outcomes in endemic regions.
How similar studies have performed: Other studies have shown promise with similar vector control approaches, but the use of spatial repellents like Mossie-GO is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinja
- Malaria Consortium — Jinja, Uganda (Recruiting)
Study contacts
- Principal investigator: Robert Jones, PhD — Arctech Innovation
- Study coordinator: Robert Jones, PhD
- Email: robert.jones@arctechinnovation.com
- Phone: +447745845880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.