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

July 4, 2019 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

223861

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • North Central Province
      • Anuradhapura, North Central Province, Sri Lanka
        • Mahaweli H area

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
ACTIVE_COMPARATOR: Storage container
Ultraviolet light resistant plastic in-ground pesticide storage container
Device: Ultraviolet light-resistant plastic in-ground pesticide storage container
In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For three years after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of All Self-poisoning
Time Frame: For three years post-intervention
Cases of self-poisoning identified
For three years post-intervention
Incidence of All Self-harm
Time Frame: For three years after intervention
For three years after intervention
Incidence of Fatal Self-harm
Time Frame: For three years post intervention
For three years post intervention
Incidence of Pesticide Poisoning
Time Frame: For three years post intervention
For three years post intervention
Incidence of Unintentional Paediatric Pesticide Poisoning
Time Frame: For three years post intervention
For three years post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

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

Investigators

  • Principal Investigator: Michael Eddleston, University of Edinburgh
  • Study Director: Flemming Konradsen, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (ESTIMATE)

June 17, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Safe Storage Protocol Sep09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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