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| Name | Class |
|---|---|
| University of Bristol | OTHER |
| University of Oxford | OTHER |
| University of Peradeniya | OTHER |
| University of Kelaniya |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Storage container | Active Comparator | Ultraviolet light resistant plastic in-ground pesticide storage container |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Eddleston | University of Edinburgh | Principal Investigator |
| Flemming Konradsen | University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahaweli H area | Anuradhapura | North Central Province | Sri Lanka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28807536 | Derived | 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. | |
| 28336743 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Storage Container | Ultraviolet light resistant plastic in-ground pesticide storage container 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 |
| FG001 | Control | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Storage Container | Ultraviolet light resistant plastic in-ground pesticide storage container 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Pesticide Self-poisoning | Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village | Posted | Count of Participants | Participants | For three years after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Storage Container | Ultraviolet light resistant plastic in-ground pesticide storage container 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eddleston | University of Edinburgh | 01312426776 | m.eddleston@ed.ac.uk |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| OTHER |
| University of Copenhagen | OTHER |
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| 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 |
| Derived |
| 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. |
| 25724984 | Derived | 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. |
| 22104027 | Derived | 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. |
| Control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Incidence of All Self-poisoning | Cases of self-poisoning identified | Posted | Count of Participants | Participants | For three years post-intervention |
|
|
|
| Secondary | Incidence of All Self-harm | Posted | Count of Participants | Participants | For three years after intervention |
|
|
|
| Secondary | Incidence of Fatal Self-harm | Posted | Count of Participants | Participants | For three years post intervention |
|
|
|
| Secondary | Incidence of Pesticide Poisoning | Posted | Count of Participants | Participants | For three years post intervention |
|
|
|
| Secondary | Incidence of Unintentional Paediatric Pesticide Poisoning | Posted | Count of Participants | Participants | For three years post intervention |
|
|
|
| 0 |
| 114,168 |
| 0 |
| 114,168 |
| EG001 | Control | No intervention | 0 | 109,693 | 0 | 109,693 |
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