CompletedNot Applicable

Spatial Repellents for the Prevention of Malaria in Kenya

Kenya5,984 participantsStarted 2021-03-02

Plain-language summary

Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. However, their efficacy in reducing mosquito biting and therefore malaria transmission has never been evaluated in Africa. This study will evaluate the efficacy of a spatial repellent in reducing mosquito biting on human beings and measure the impact any reduced biting will have on malaria transmission. The investigators will recruit and follow-up 5,984 children between 6 months and \<10 years of age in Busia County to determine how many times they will be infected with malaria in villages where the investigators will have distributed spatial repellents and compare the rate of infection to villages where the investigators will not have distributed the repellent devices. Additionally, the investigators will measure whether the distribution of spatial repellents in one village will drive mosquitoes to their neighboring houses thereby increasing malaria transmission in those areas. The children participating in the study will be divided into 3 groups (cohorts). The first group will be followed up during the first 4 months before any intervention is distributed and the purpose here will be to determine that the villages are comparable. After this, the investigators will recruit the next group of participants and follow them up for 1 year and repeat this again for another year. During the follow-up, the children will be asked to come to the health facility where they will be tested for malaria using RDT or blood slide for microscopy. Every two weeks, a member of the study team will come to the participant's house and ask them if they had any history of fever. If the participants had fever, they will be tested for malaria. All children who turn out to be positive for malaria by RDT will be treated free of charge. At the same time, the investigators shall also perform mosquito collections to determine the impact of spatial repellents on the density of Anopheles mosquitoes.

Who can participate

Age range6 Months – 10 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 6 months to \<10 years * Hb \> 5mg/dl * Sleeps in cluster \>90% of nights during any given month * No plans for extended travel (\>1month) 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 signed by the parent(s) or guardian * Children not on regular malaria prophylaxis° such as Proguanil * Willingness to take AL and no history of hypersensitivity to AL Exclusion Criteria: * Children \< 6 months or ≥ 10 years * Hb ≤ 5 mg/dL, or Hb \< 6mg/dL with signs of clinical decompensation * Sleeps in cluster \<90% of nights during any given month * Plans for extended travel (\>1month) 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 informed consent form signed by the parent(s) or guardian * Children on regular malaria prophylaxis° such as Proguanil * Unwillingness or refusal to take AL and history of AL hypersensitivity * Other malaria prophylaxis medicines: Mefloquine, Atavaquone/Proguanil (Malarone), Doxycycline, Tafenoquine, Sulfadoxine-Pyrimethamine (Fansidar), Amodiaquine and Co-trimoxazole (Septrin)

What they're measuring

First-time malaria infection in core zones during intervention period.

Timeframe: 12 months

Trial details

NCT IDNCT04766879

SponsorUniversity of Notre Dame

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-23