Methods and Results: We have started a community-based cluster randomised controlled trial (RCT) of the effectiveness of safe storage containers to reduce pesticide self-poisoning. We will recruit rural villages from five administrative divisions in the Anuradhapura District of Sri Lanka. Community approval will be sought and a census carried out, collecting baseline data from all households on demographics, pesticide usage, previous self-reported self-harm and socio-economic status. Intervention households, determined by their use of pesticides, will be offered a free UV-resistant polyethylene in-ground container with a lock. The safe storage device was developed and piloted following input from industry and farmers. The primary outcome will be the incidence of pesticide self-poisoning, both fatal and non-fatal. Secondary outcomes will include the incidences of pesticide poisoning, self-harm (all methods both fatal and non-fatal), self-poisoning (all substances) and unintentional poisoning in children. Power calculations suggest that 217,944 person years of follow-up are required in each arm of the trial to compensate for non-eligibility, non-compliance and contamination (24,216 households; 81 villages per arm; total 162 villages).
Discussion: The presentation will discuss the challenges of conducting such a study, including design issues with the safe storage device; community engagement; logistics; and promotion activities to ensure compliance.