Home » Trials » SLCTR/2019/013


Development and evaluation of a complex intervention to change the behaviour of the householders’ to prevent dengue in the Kurunegala District

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SLCTR Registration Number

SLCTR/2019/013


Date of Registration

31 Mar 2019

The date of last modification

Apr 01, 2019



Application Summary


Scientific Title of Trial

Development and evaluation of a complex intervention to change the behaviour of the householders’ to prevent dengue in the Kurunegala District


Public Title of Trial

A behavioral intervention among householders in the Kurunegala district to prevent dengue infection: A randomized control trial


Disease or Health Condition(s) Studied

Dengue


Scientific Acronym

None


Public Acronym

None


Brief title

An Intervention to Change the Behaviour of the Householders’ to Prevent Dengue in Kurunegala District


Universal Trial Number

U1111-1226-1389


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

EC-18-134 (ERC: University of Colombo)


Trial Details


What is the research question being addressed?

Can a behavioural intervention be effective in changing behavior in householders of a selected highly epidemic area of the Kurunegala district?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Healthcare providers, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

Study setting It will be conducted in the highly epidemic Medical Officers of Health (MOH) area in the Kurunegala district

Randomization The total number of households (those selected six pairs of matched clusters) belongs to the MOH area, will be randomized into two arms (intervention arm and the control arm) using the computer generator method (simple randomization) after selecting the participants in each cluster by third-party assignment to prevent the selection bias.

Intervention The overall goal of the intervention package is to “change the behaviours of the community to prevent dengue in a highly epidemic MOH area in Kurunegala district”. This is to be achieved using a Communication for behavioural Impact (COMBI) plan. Prior to developing a proper COMBI plan, Situational Market Analysis for Communication Keys (SMACK) was conducted to develop Specific Behavioural Objectives (SBOs). It was conducted by quantitative assessment (Part A) and qualitative assessment (Part B). Designing of the COMBI plan was done according to WHO 10 steps using the data from above assessments (Parks & Lloyd, 2004; The Communication Initiative Team, 2004; WHO et al., 2012; HEB, 2017).

Developed and piloted intervention will be implemented at the cluster level. A cluster will consist of 25 householders.25 householders from one randomly selected Grama niladhari division (GN division) will be gathered into a closest community gathering area and the sessions will be conducted. Altogether 150 (25x6) will be trained to change the behaviour to prevent dengue.

The intervention will be applied as a single session for each cluster of 25 householders and following up at the household level once a week for four weeks. Post-interventional assessment will be conducted after three months of completion of the intervention.

Details of intervention package

Introduction to dengue and prevention - by Consultant Community Physician

MODULE 01 The manifestation of dengue infection and vector bionomics by Medical Officer (MO)/ Vector born disease with the guidance of Provincial Consultant Community Physician

MODULE 02 Prevention of dengue through behaviour change by Consultant Community Physician, Health Promotion bureau.

MODULE 03 Methods of Behaviour change and importance of COMBI by Health Education Officer (HEO) What is COMBI and the COMBI plan for the area?. By the investigators

MODULE 04 Planning, Implementation and Monitoring of the Intervention plan By the investigators with multi-stakeholders ( Pradeshiya sabha, Agriculture department, NGOO) Q&A session by the investigators with multi-stakeholders

The control group will consist of randomly selected one GN division from each PHI area. It will have no special intervention. The control group are eligible for routine standards of dengue control activities. The current activities are house to house inspection by dengue field assistance and range Public Health Inspectors (PHII), monthly larval surveillance in identified sentinel surveillance sites by entomological assistance, fogging around 200m radius of the detected dengue case and time to time “shramadhana” campaigns in high risk areas.

Blinding. Healthcare providers including MOH/ Additional Medical Officer of Health (AMOH)/ Public Health Inspectors will be blinded on the recruitment of the study group and control group to prevent the potential bias. Outcome assessors will be blinded after assignment to interventions to prevent the detection bias. So, they will be kept blind to the status of the groups. Data entry operators also will be blinded for the status of the intervention.


Inclusion criteria

Include all individuals in a selected single building households, age between 18 and 70 years both males and females.

The “study unit” will be formed by separate single building utilized as a household in Kurunegala district. A household is defined as “a place where a person, or a group of persons who usually live and have a common arrangement for the preparation and consumption of food” (SLDHS, 2016). If there are two or more families live in upstairs and downstairs or annexures in the same premises, those units will be taken as separate households because the behaviour and the premises vector indices will be different from one household to another. Because the primary and secondary outcome will be assessed at the individual level.


Exclusion criteria

Temporary shelters which were built for the period of fewer than six months will be excluded



Primary outcome(s)

1.

The dengue prevention behavior among the community members in the intervention group and the control group at three months of post intervention. It will be assessed at household level (individual). It will be assessed using the behaviour part of the Interviewer Administered Questioner (IAQ) and household observations and cut off mark of the adequate behaviors will be 60%. Out of those behaviour assessment areas, percentage of practicing the recommended behaviours will be taken in pre and post intervention in both control and intervention groups

[

Pre intervention and three months post intervention

]

Secondary outcome(s)

1.

Differences in pre and post intervention of: 1. Pupal Index 2. Breteau Index 3. Premise index 4.Container Index

Defined as below, 1. “Pupal Index”= number of pupae per 100 houses inspected 2. “Breteau Index” = number of positcontainers per 100 houses inspected. 3. “Premise index”= percentage of premises infested with larvae and/or pupae. 4. “Container Index”= percentage of wet containers infested with larvae or pupae

[

Pre intervention and three months post intervention

]

Target number/sample size

300


Countries of recruitment

Sri Lanka


Anticipated start date

2019-04-08


Anticipated end date

2019-08-08


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Not yet applied


Regulatory approvals

Ministry of Health, Sri Lanka



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-12-20


Approval number

EC-18-134


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo.
Institutional Address:No. 25, Kynsey Road, Colombo 00800, Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.R.M.N.U.Rajapaksha
Registrar in Community Medicine
Post Graduate Institute of Medicine University of Colombo

0778974176/0712777130

rmnur2014@gmail.com
http://medicine.kln.ac.lk/depts/publichealth/staff/temporary-staff-post-graduate-students/97-staff/296-dr-r-m-nayani-umesha-rajapaksha.html

Contact Person for Public Queries

Professor Chrishantha Abeysena
Professor
Department of Public Health, Faculty of Medicine, Ragama, Sri Lanka

0710822848/0777591715

chrishanthaabeysena@yahoo.com
http://medicine.kln.ac.lk/depts/publichealth/prof-abeysena.html


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


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

Yes


IPD sharing plan description

Individual participant data that underlie the results will be shared after the de-identification (tables, figures, appendices). This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose, to achieve the aims of the approved proposal. Proposal should be directed to rmnur2014@gmail.co


Study protocol available

No


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