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Completed

NCT Number: NCT01146496

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

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.

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Key information

Conditions

Pesticide Poisoning Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahaweli H area

Anuradhapura, North Central Province, Sri Lanka

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Ultraviolet light-resistant plastic in-ground pesticide storage container

Device

In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages

Primary outcomes

  1. Incidence of Pesticide Self-poisoning

    Time frame: 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 outcomes

  1. Incidence of All Self-poisoning

    Time frame: For three years post-intervention

    Cases of self-poisoning identified

  2. Incidence of All Self-harm

    Time frame: For three years after intervention

  3. Incidence of Fatal Self-harm

    Time frame: For three years post intervention

  4. Incidence of Pesticide Poisoning

    Time frame: For three years post intervention

  5. Incidence of Unintentional Paediatric Pesticide Poisoning

    Time frame: For three years post intervention

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • University of Bristol
  • University of Copenhagen
  • University of Kelaniya
  • University of Oxford
  • University of Peradeniya

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
Jun 17, 2010
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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