Study protocol: an open-label individually randomised controlled trial to assess the efficacy of artemether-lumefantrine prophylaxis for malaria among forest goers in Cambodia

Introduction In the Greater Mekong Subregion, adults are at highest risk for malaria. The most relevant disease vectors bite during daytime and outdoors which makes forest work a high-risk activity absence of effective vector control strategies limited periods exposure visits suggest that chemoprophylaxis could be an appropriate strategy to protect goers against Methods analysis protocol describes open-label randomised controlled trial artemether-lumefantrine (AL) versus multivitamin as prophylaxis malaria among aged 16–65 years in rural northeast Cambodia. primary objective is compare efficacy artemisinin combination therapy AL preparation defined by 28-day PCR parasite positivity rate incidence confirmed clinical any species. sample size 2200 patient-episodes duration 1 month each arm. follow-up participant 1, 2 or 3 consecutive periods, followed further 28 days post-exposure prophylaxis, depending on whether they continue visit forest. Analysis will done both intention treat per protocol. Ethics dissemination All participants provide written, informed consent. Ethical approval was obtained from Oxford Tropical Research Committee Cambodia National Health Research. Results disseminated peer-reviewed open access publication together with data. Trial registration number NCT04041973 ; Pre-result.