A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia

Not Applicable

Completed

• Conditions: Pesticide Poisoning
• Interventions: Device: Ultraviolet light-resistant plastic in-ground pesticide storage container

• Registration Number: NCT01146496
• Lead Sponsor: University of Edinburgh

Brief Summary

A major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. The aim of this work is to determine whether the provision of lockable storage containers to poor households in rural Asia can reduce the incidence of intentional pesticide self-poisoning. Secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.

Detailed Description

We will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning.

The study will be based in Anuradhapura District where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed.

The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clustering and stratification, for the analysis.

The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia.

Study Timeline

• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Study Start: 2010-12
• Primary Completion: 2013-05
• Study Completion: 2016-06
• Results First Submitted: 2019-04-16
• Results First Submitted QC: 2019-04-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223861

Inclusion Criteria

• Any village in the study area that gives consent to the study

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Storage container	Ultraviolet light-resistant plastic in-ground pesticide storage container	Ultraviolet light resistant plastic in-ground pesticide storage container

Primary Outcome Measures

Name	Time	Method
Incidence of Pesticide Self-poisoning	For three years after intervention	Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village

Secondary Outcome Measures

Name	Time	Method
Incidence of All Self-harm	For three years after intervention
Incidence of Fatal Self-harm	For three years post intervention
Incidence of Pesticide Poisoning	For three years post intervention
Incidence of Unintentional Paediatric Pesticide Poisoning	For three years post intervention
Incidence of All Self-poisoning	For three years post-intervention	Cases of self-poisoning identified

Trial Locations

Locations (1)

Mahaweli H area; 🇱🇰 Anuradhapura, North Central Province, Sri Lanka