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
The date of last modification
Sep 16, 2020
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)
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
2019-05-24
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
Not yet applied
Regulatory approvals
Ministry of Health, Sri Lanka
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 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
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.com
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