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

Primary Purpose

Pesticide Poisoning

Status
Completed
Phase
Not Applicable
Locations
Sri Lanka
Study Type
Interventional
Intervention
Ultraviolet light-resistant plastic in-ground pesticide storage container
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pesticide Poisoning focused on measuring Pesticide poisoning, Suicide, Unintentional poisoning, Prevention, Cluster randomised controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Mahaweli H area

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Storage container

Control

Arm Description

Ultraviolet light resistant plastic in-ground pesticide storage container

Outcomes

Primary Outcome Measures

Incidence of Pesticide Self-poisoning
Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village

Secondary Outcome Measures

Incidence of All Self-poisoning
Cases of self-poisoning identified
Incidence of All Self-harm
Incidence of Fatal Self-harm
Incidence of Pesticide Poisoning
Incidence of Unintentional Paediatric Pesticide Poisoning

Full Information

First Posted
June 16, 2010
Last Updated
July 4, 2019
Sponsor
University of Edinburgh
Collaborators
University of Bristol, University of Oxford, University of Peradeniya, University of Kelaniya, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01146496
Brief Title
A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
Official Title
A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
University of Bristol, University of Oxford, University of Peradeniya, University of Kelaniya, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pesticide Poisoning
Keywords
Pesticide poisoning, Suicide, Unintentional poisoning, Prevention, Cluster randomised controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223861 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Storage container
Arm Type
Active Comparator
Arm Description
Ultraviolet light resistant plastic in-ground pesticide storage container
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Ultraviolet light-resistant plastic in-ground pesticide storage container
Intervention Description
In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages
Primary Outcome Measure Information:
Title
Incidence of Pesticide Self-poisoning
Description
Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village
Time Frame
For three years after intervention
Secondary Outcome Measure Information:
Title
Incidence of All Self-poisoning
Description
Cases of self-poisoning identified
Time Frame
For three years post-intervention
Title
Incidence of All Self-harm
Time Frame
For three years after intervention
Title
Incidence of Fatal Self-harm
Time Frame
For three years post intervention
Title
Incidence of Pesticide Poisoning
Time Frame
For three years post intervention
Title
Incidence of Unintentional Paediatric Pesticide Poisoning
Time Frame
For three years post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any village in the study area that gives consent to the study Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Eddleston
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flemming Konradsen
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Mahaweli H area
City
Anuradhapura
State/Province
North Central Province
Country
Sri Lanka

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28807536
Citation
Pearson M, Metcalfe C, Jayamanne S, Gunnell D, Weerasinghe M, Pieris R, Priyadarshana C, Knipe DW, Hawton K, Dawson AH, Bandara P, deSilva D, Gawarammana I, Eddleston M, Konradsen F. Effectiveness of household lockable pesticide storage to reduce pesticide self-poisoning in rural Asia: a community-based, cluster-randomised controlled trial. Lancet. 2017 Oct 21;390(10105):1863-1872. doi: 10.1016/S0140-6736(17)31961-X. Epub 2017 Aug 11. Erratum In: Lancet. 2017 Dec 9;390(10112):2548.
Results Reference
derived
PubMed Identifier
28336743
Citation
Knipe DW, Gunnell D, Pieris R, Priyadarshana C, Weerasinghe M, Pearson M, Jayamanne S, Dawson AH, Mohamed F, Gawarammana I, Hawton K, Konradsen F, Eddleston M, Metcalfe C. Is socioeconomic position associated with risk of attempted suicide in rural Sri Lanka? A cross-sectional study of 165 000 individuals. BMJ Open. 2017 Mar 22;7(3):e014006. doi: 10.1136/bmjopen-2016-014006.
Results Reference
derived
PubMed Identifier
25724984
Citation
Madsen LB, Eddleston M, Hansen KS, Pearson M, Agampodi S, Jayamanne S, Konradsen F. Cost-effectiveness analyses of self-harm strategies aimed at reducing the mortality of pesticide self-poisonings in Sri Lanka: a study protocol. BMJ Open. 2015 Feb 27;5(2):e007333. doi: 10.1136/bmjopen-2014-007333.
Results Reference
derived
PubMed Identifier
22104027
Citation
Pearson M, Konradsen F, Gunnell D, Dawson AH, Pieris R, Weerasinghe M, Knipe DW, Jayamanne S, Metcalfe C, Hawton K, Wickramasinghe AR, Atapattu W, Bandara P, de Silva D, Ranasinghe A, Mohamed F, Buckley NA, Gawarammana I, Eddleston M. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka: study protocol. BMC Public Health. 2011 Nov 21;11:879. doi: 10.1186/1471-2458-11-879.
Results Reference
derived

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

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