Home » Trials » SLCTR/2019/006


Cluster Randomized Controlled Trial to Determine whether Pesticide Vendor Training Reduces Pesticide Self-poisoning in Rural Asia

-

SLCTR Registration Number

SLCTR/2019/006


Date of Registration

14 Feb 2019

The date of last modification

Aug 24, 2019



Application Summary


Scientific Title of Trial

Cluster Randomized Controlled Trial to Determine whether Pesticide Vendor Training Reduces Pesticide Self-poisoning in Rural Asia


Public Title of Trial

Trial of Pesticide Vendor Training to Reduce Pesticide Self-poisoning in Rural Asia


Disease or Health Condition(s) Studied

Self poisoning, self harm


Scientific Acronym

Vendor cRCT


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1220-8046


Any other number(s) assigned to the trial and issuing authority

ERC/2018/030 (Ethics Review Committee: Rajarata University of Sri Lanka); 18-HV-053 (ACCORD Medical Research Ethics Committee (AMREC), University of Edinburgh)


Trial Details


What is the research question being addressed?

Does gatekeeper training for pesticide vendors prevent pesticide self-poisoning without increasing the incidence of other forms of self-harm?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Outcome assessors


Control

Historical


Assignment

Other


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

Type of intervention: public health stepped wedge cluster randomized controlled trial of a community based intervention

Study setting: North Central Province of Sri Lanka. Divisional Secretariat clusters will be the unit of randomization.

Method of Randomisation: Simple randomization will be utilized to randomize the sequence of enrolment of the clusters over time

Description of Intervention: The intervention involves training pesticide vendors to identify a person at high-risk of self-poisoning with the purchased pesticide (gatekeeper function) and to then refuse to make a sale (means restriction). Its form is based on the pilot study, and consists of a 2 hr session that includes 1-hour discussion with vendors on their experience with self-poisoning clients followed by a 1-hour interactive presentation on how to identify and respond to high risk clients. Vendors will be trained to observe customer behaviour, check for intoxication, and ask questions for which farmers would be expected to know the answer.

The intervention will be delivered by 2 professional trainers and 4 assistants who will be employed on the project. Follow-up refresher training will be offered on an annual basis to all vendors who participated in the initial training by the same staff. New sales staff will be ask to attend initial training.

The control is historical but within the stepped wedge cRCT design. The clusters will act as controls for themselves and time trends analysed horizontally. The intervention divisions are selected at random. Those divisions that have not yet been selected for intervention are control divisions

Blinding: outcome assessors will be blinded to intervention status.


Inclusion criteria

All pesticide shops (regardless of whether they hold a government license to sell pesticides) and sales personnel in NCP during the period of the study will be eligible


Exclusion criteria

Pesticide shops located 10 km or more from the study area boundary will be excluded from the study because this distance is outside of the usual travelling distance for pesticide purchases, as noted in the Vendor pilot study.



Primary outcome(s)

1.

The number of patients admitted with pesticide poisoning in the surveillance hospitals

[

Timepoint: At baseline and end of study. Note: Surveillance will be continuous for 3 years. Daily to weekly surveillance will be undertaken, with the frequency determined by the size of hospitals and the number of admissions

]

Secondary outcome(s)

1.

The number of patients admitted with other (non-pesticide) self-harm

[

Timepoint: At baseline and end of study. Note: Surveillance will be continuous for 3 years. Daily to weekly surveillance will be undertaken, with the frequency determined by the size of hospitals and the number of admissions

]

Target number/sample size

30 Clusters


Countries of recruitment

Sri Lanka


Anticipated start date

2019-02-18


Anticipated end date

2022-12-31


Date of first enrollment

2019-04-01


Date of study completion


Recruitment status

Recruiting


Funding source

American Foundation for Suicide Prevention (Ref. no. IIG-0-002-17)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-10-16


Approval number

ERC/2018/30


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka.
Institutional Address:2nd Floor, Para-clinical Building, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
Telephone:+94 252053633
Email: ethicsreviewcommittee@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Michael Eddleston
Professor of Clinical Toxicology
University of Edinburgh QMRI 47 Little France Crescent Edinburgh EH16 4TJ
Tel: (+44)-131-242-1383


M.Eddleston@ed.ac.uk

Contact Person for Public Queries

Dr Manjula Weerasinghe
Post doctoral researcher
Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka

Mob: (077) 323 0888

manjugaya@yahoo.com


Primary study sponsor/organization

University of Edinburgh

QMRI 47 Little France Crescent Edinburgh EH16 4TJ, UK
(+44)-131-242-1383

M.Eddleston@ed.ac.uk

Secondary study sponsor (If any)

South Asian Clinical Toxicology Research Collaboration

Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
+081-4479822

enquiry@sactrc.org
www.sactrc.org

Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

Not available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results