Home » Trials » SLCTR/2015/015
A randomized controlled trial to assess the effectiveness of selected health educational methods on improving uptake of cervical screening in a population of women in the Puttalam district
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SLCTR Registration Number
SLCTR/2015/015
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
A randomized controlled trial to assess the effectiveness of selected health educational methods on improving uptake of cervical screening in a population of women in the Puttalam district
Public Title of Trial
A study to assess the effectiveness of selected health educational methods to improve cervical screening in a population of women in the Puttalam district
Disease or Health Condition(s) Studied
Cervical screening
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1172-0763
Any other number(s) assigned to the trial and issuing authority
ERC Kelaniya Ref. P/08/01/2015
What is the research question being addressed?
Can the cervical cancer screening participation in MOH areas (Nattandiya and Dankotuwa) of Puttalam District be increased using mailed, call and community support group interventions?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Factorial
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Participants will be selected from the Eligible family registers of the Public Health Midwife (PHM) of Medical officer of Health (MOH) Office. The study consists of three interventions with a 2 X 2 X 2 factorial design and 8 arms, as follows:
Arm 1: Community support group (CSG) + Mail + Phone
Arm 2: CSG + Mail (No Phone)
Arm 3: CSG + Phone (No Mail)
Arm 4: CSG only (No Mail, No Phone)
Arm 5: Mail + Phone (No CSG)
Arm 6: Mail only (No CSG, No Phone)
Arm 7: Phone only (No CSG, No Mail)
Arm 8: Standard management (No CSG, No Mail, No Phone)
The CSG intervention will be delivered under the guidance of PHM through the CSG community members.
The Mail intervention (includes a health education leaflet and invitation letter to the Well Women Clinic) will be delivered through the MOH offices with assistance from area PHM.
The Phone intervention (includes standardised health education and invitation to the Well Women Clinic) will be delivered by the area PHM.
Each intervention will be delivered twice. First as the invitation with health education and after 3 months.
Standard therapy of the usual home visit by the PHM and invitation for females aged 35 years to participate in the well women clinic will be offered to all.
Inclusion criteria
Females aged 35 years of Nattandiya and Dankotuwa MOH areas
Exclusion criteria
Mental sub-normality (lacking the capacity to participate in the interventions) as determined by a medical officer
Primary outcome(s)
|
1.
Females with documented evidence of participation in the well women clinic and undergoing the Pap test (obtained by clinic records) |
[ At 3 months and 6 months after intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
544 (68 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-09-01
Anticipated end date
2016-03-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
MRI- Medical Research Institute Colombo (no. 5/2015)
Regulatory approvals
Status
Approved
Date of Approval
2015-01-28
Approval number
P/08/01/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Yoshani K. J. Fernando
Registrar in Community Medicine
Ministry of Health, Sri Lanka
Tel: 0777373480
Fax: 0312253205
yoshani76fernando@gmail.com
Contact Person for Public Queries
Prof A. Pathmeswaran
Professor
Department of Public Health
Faculty of Medicine
University of Kelaniya
Tel: 0776726762
pathmes@gmail.com
Primary study sponsor/organization
Regional Director of Health Services
Office of Regional Director of Health Services, Puttalam Hospital Building, Madampe
Tel: 0322247261
Fax: 0322248857
dpdhs puttalam@yahoo.com
Secondary study sponsor (If any)
Medical Research Institute
P.O. Box 527
Colombo 08, Sri Lanka
Tel: 94 2 693532-34
Fax: 94 2 691495
director@mri.gov.lk
http://www.mri.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
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
