Reducing Filth Fly Populations and Transmission of Diarrhoeal Pathogens in Harsh Settings: a Cross-over Trial in South Sudan
Objectives The main trial objective is to evaluate the efficacy of larvicide (LARV) or baited fly traps (TRAP), or both interventions combined, on filth fly density and hence transmission of diarrhoeal diseases. Primary Objective • To evaluate the efficacy of LARV or TRAP, or both interventions combined, in reducing the number of cases of all-cause diarrhoea (primary epidemiological endpoint). Secondary Objectives * To evaluate the efficacy of LARV or TRAP, or both interventions combined, in reducing filth fly density and species composition at the latrine level (primary entomological endpoint). * To evaluate the efficacy of LARV or TRAP, or both interventions combined, in reducing filth fly density and species composition at the shelter level (secondary entomological endpoint). Tertiary Objectives * To assess the impact of LARV or TRAP, or both interventions combined, on enteric pathogen species composition and density (tertiary entomological endpoint). * To assess the impact of LARV or TRAP, or both interventions combined, on enteric pathogen antimicrobial resistance (AMR) prevalence (tertiary entomological endpoint). Trial Design The proposed trial will be a 3-period, 3-group, interventional non-randomized cross-over trial with parallel control (Table 1). The unit of intervention will be an individual refugee camp. Each implementation phase will be 6 months, followed by a 1-month wash-out period. The trial arms will be: 1. No intervention (control arm) 2. Dimilin® larvicide (intervention arm 1) 3. iCatchi® ProMax fly traps (intervention arm 2)
• Individuals of either ≤5 years old or ≥15 years old all ages
• Slept in camp ≥27 nights during any given month
• Individual is not severely malnourished, sick, anemic (self-reported), has signs of clinical decompensation, and/or has any other chronic co-morbidities (e.g. HIV or cancer)
• No plans for extended travel (\>1 month) outside of camp during study
• Resides in an easily accessible dwelling and is present at time of enrolment
• 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 (≤5s), able to give informed consent as an adult or able to give informed assent for children ≥15 years