Date

2021-12-16

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

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.

Next Version

Type of intervention: public health stepped wedge cluster randomized controlled trial of a community-based intervention Study setting: About 2.7 million people in 70 Divisional Secretariat Divisions in Sri Lanka, primarily from six districts (Anuradhapura 22 divisions, Polonnaruwa 7, Matale 11, Vavuniya 4, Batticaloa 14, and Trincomalee 11) and 1 division (Dehiattakandiya) from Ampara District. The unit of randomization (cluster) is one or more (usually two) divisions Method of Randomization: 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 3 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 asked 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.