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

NCT ID: NCT01146496

Last Updated: 2019-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223861 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-06-30

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.

Conditions

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Pesticide Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Storage container

Ultraviolet light resistant plastic in-ground pesticide storage container

Group Type ACTIVE_COMPARATOR

Ultraviolet light-resistant plastic in-ground pesticide storage container

Intervention Type DEVICE

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bristol

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Peradeniya

OTHER

Sponsor Role collaborator

University of Kelaniya

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Eddleston

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Flemming Konradsen

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Mahaweli H area

Anuradhapura, North Central Province, Sri Lanka

Site Status

Countries

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Sri Lanka

References

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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.

Reference Type DERIVED
PMID: 28807536 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28336743 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25724984 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22104027 (View on PubMed)

Other Identifiers

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Safe Storage Protocol Sep09

Identifier Type: -

Identifier Source: org_study_id

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