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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pesticide Poisoning

Intervention / Treatment
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* Device: Ultraviolet light-resistant plastic in-ground pesticide storage container


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any village in the study area that gives consent to the study Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Storage container<br>Ultraviolet light resistant plastic in-ground pesticide storage container | Device: Ultraviolet light-resistant plastic in-ground pesticide storage container<br>* In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pesticide Self-poisoning | Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village | For three years after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of All Self-poisoning | Cases of self-poisoning identified | For three years post-intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pesticide poisoning, Suicide, Unintentional poisoning, Prevention, Cluster randomised controlled trial