Home » Trials » SLCTR/2019/006
Cluster Randomized Controlled Trial to Determine whether Pesticide Vendor Training Reduces Pesticide Self-poisoning in Rural Asia
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SLCTR Registration Number
SLCTR/2019/006
Date of Registration
The date of last modification
Jan 13, 2022
Trial Status
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)
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
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 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
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
