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

Agius 2020.

Study characteristics
Methods cRCT (stepped‐wedge)
Unit of randomization: clusters of villages
ICC: 0.15
Trial duration: approximately 15 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: 12% N, N‐diethylbenzamide cream
Controls: no intervention
Co‐interventions: LLINs
Treatment arms:
  • since this was a stepped wedge trial, all clusters moved from control to intervention. There were 14 clusters (116 villages, approx. 31,016 people)

Outcomes
  • Malaria prevalence

  • 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)

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

Notes Malaria case incidence is mentioned as an outcome in the paper, but not reported
Carried out in Myanmar
Funded by: Three Millennium Development Goal, Australian Research Council, Australian Centre for Research Excellence in Malaria Elimination