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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01146496
Enrollment
223861
Registered
2010-06-17
Start date
2010-12-31
Completion date
2016-06-30
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pesticide Poisoning

Keywords

Pesticide poisoning, Suicide, Unintentional poisoning, Prevention, Cluster randomised controlled trial

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.

Interventions

DEVICEUltraviolet 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

Sponsors

University of Bristol
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
University of Peradeniya
CollaboratorOTHER
University of Kelaniya
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Pesticide Self-poisoningFor three years after interventionCases identified by survey of local and referral hospitals and by regular interview of primary informants in each village

Secondary

MeasureTime frameDescription
Incidence of All Self-poisoningFor three years post-interventionCases of self-poisoning identified
Incidence of All Self-harmFor three years after intervention
Incidence of Fatal Self-harmFor three years post intervention
Incidence of Pesticide PoisoningFor three years post intervention
Incidence of Unintentional Paediatric Pesticide PoisoningFor three years post intervention

Countries

Sri Lanka

Participant flow

Participants by arm

ArmCount
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
114,168
Control109,693
Total223,861

Baseline characteristics

CharacteristicStorage ContainerControlTotal
Age, Customized
Number >14 years
87751 Participants84469 Participants172220 Participants
Race/Ethnicity, Customized
Sri Lankan
114168 Participants109693 Participants223861 Participants
Region of Enrollment
Sri Lanka
114168 participants109693 participants223861 participants
Sex/Gender, Customized
Females >14 yrs
44693 Participants43105 Participants87798 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 114,1680 / 109,693
serious
Total, serious adverse events
0 / 114,1680 / 109,693

Outcome results

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

Time frame: For three years after intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of Pesticide Self-poisoning611 Participants
ControlIncidence of Pesticide Self-poisoning641 Participants
Secondary

Incidence of All Self-harm

Time frame: For three years after intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of All Self-harm1217 Participants
ControlIncidence of All Self-harm1220 Participants
Secondary

Incidence of All Self-poisoning

Cases of self-poisoning identified

Time frame: For three years post-intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of All Self-poisoning1155 Participants
ControlIncidence of All Self-poisoning1173 Participants
Secondary

Incidence of Fatal Self-harm

Time frame: For three years post intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of Fatal Self-harm82 Participants
ControlIncidence of Fatal Self-harm67 Participants
Secondary

Incidence of Pesticide Poisoning

Time frame: For three years post intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of Pesticide Poisoning633 Participants
ControlIncidence of Pesticide Poisoning662 Participants
Secondary

Incidence of Unintentional Paediatric Pesticide Poisoning

Time frame: For three years post intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Storage ContainerIncidence of Unintentional Paediatric Pesticide Poisoning18 Participants
ControlIncidence of Unintentional Paediatric Pesticide Poisoning15 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026