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. 2023 Aug 21;2023(8):CD015422. doi: 10.1002/14651858.CD015422.pub2

Sluydts 2016.

Study characteristics
Methods cRCT
Unit of randomization: cluster made up by individual villages or a group of closely located villages
ICC: not reported, retrospectively calculated: 0.0294
Trial duration: 20 months
Participants Adults or children living in malaria endemic regions
High risk population (forest workers)
Endemic region for P vivax
Participants not screened for hypnozoites
Interventions Topical repellent: picaridin (KBR3023)
Controls: no treatment
Picaridin 10% for children < 10 years, and Picaridin 20% in individuals ≥ 10 years
Co‐interventions: LLINs
Treatment arms:
  • Intervention: 49 clusters, 57 villages (5642 households, 25,051 individuals)

  • Controls: 49 clusters, 56 villages (5287 households, 23,787 individuals)

Outcomes
  • Malaria case incidence: new cases of clinical malaria (caused by Plasmodium spp.) confirmed through blood smears or RDTs

  • Incidence of recorded adverse events (including skin irritation, local pain, eye irritation, irritation of upper airways, nausea, vomiting, headaches, dizziness or confusion, allergic or anaphylactic reactions, and systemic toxicity)

  • Malaria prevalence

  • Adherence to regular usage of the intervention (defined based on recommendations provided by researchers to participants of individual trials)

Notes Carried out in Cambodia
Funded by: Bill and Melinda Gates Foundation, Belgian Cooperation

cRCT: cluster‐randomized controlled trial; ICC: intra‐class correlation coefficient; LLIN: long‐lasting insecticide‐treated nets; RDTs: rapid diagnostic tests