Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000497404
Ethics application status
Approved
Date submitted
19/01/2025
Date registered
22/05/2025
Date last updated
8/06/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Improving Cervical Cancer Screening Through Community Health Workers and Community Information Channel for Women in Slum Areas of Pokhara, Nepal
Scientific title
Effectiveness of Community Health Worker and Community Information Channel Interventions in Cervical Cancer Screening Knowledge and Behavior among Women in Slum Areas of Pokhara Metropolitan, Nepal: A Quasi-Experimental Study
Secondary ID [1] 313759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 336361 0
Condition category
Condition code
Cancer 332896 332896 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Firstly, two slum areas of Pokhara Metropolitan City will be selected purposively to ensure participants from both the control and intervention groups share similar characteristics. Secondly, the intervention and control slum area will be choosen conveniently. Thirdly, lists of eligible participants will be prepared and they will be selected randomly for the study.

Community health workers (CHWs), refers to the participants who have at least secondary level of education and will be trained to provide awareness in the intervention group.

CHWs will be mobilized in the intervention group using flip charts and brochures The contents in flip charts and brochures include introduction, risk factors, symptoms, screening methods and preventive measures of cervical cancer. CHWs will reach the doors of the participants for providing health education on cervical cancer which will be monitored by the PI using session education checklists.

Regarding the training, CHWs will be trained after the baseline study by the PI using presentation slides. The mode of administration will be face-to-face. The training will be of one day (approximately 4 hours). CHWs will start the intervention after a day of receiving the training. CHWS will visit the participants just once for education session which will take approximately 15 minutes for each participants. All of the participants of the intervention group will recieve the intervention.
Intervention code [1] 330339 0
Behaviour
Comparator / control treatment
Control group will receive community information channel (posters from the National Health Education Information Community Centre). The poster contains definition, risk factors, symptoms and screening methods of cervical cancer.
Control group
Active

Outcomes
Primary outcome [1] 340422 0
Change in knowledge of cervical cancer.
Timepoint [1] 340422 0
Baseline, 3rd and 6th week from baseline
Secondary outcome [1] 443999 0
Change in the cervical cancer screening uptake.
Timepoint [1] 443999 0
Baseline, 3rd and 6th week from baseline

Eligibility
Key inclusion criteria
1. Women aged 30-60 years residing in the slum area.
2. Those who are not planning to migrate to another place in the next 3 months.
3. Women who have not already been diagnosed with cervical cancer.
Minimum age
30 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Women who are currently pregnant.
2. Those who have undergone a hysterectomy

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical Package for Social Sciences (SPSS v25) will be used to store and analyze quantitative data. A descriptive analysis will be performed, wherein means and standard deviations (SD) will be used to characterize continuous variables while frequencies and percentages will be used to summarize categorical data. P-values will be calculated, and less than 0.05 will be deemed statistically significant in all two-sided analyses, where needed, using the student’s t-test, Pearson's chi-squared test, and ANOVA test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/01/2025
Date of last participant enrolment
Anticipated
Actual
30/01/2025
Date of last data collection
Anticipated
Actual
13/03/2025
Sample size
Target
310
Accrual to date
Final
310
Recruitment outside Australia
Country [1] 26834 0
Nepal
State/province [1] 26834 0
Gandaki

Funding & Sponsors
Funding source category [1] 318214 0
Government body
Name [1] 318214 0
Gandaki Province Academy of Science and Technology (GPAST)
Country [1] 318214 0
Nepal
Primary sponsor type
Individual
Name
Abhishek Sapkota-Pokhara University
Address
Country
Nepal
Secondary sponsor category [1] 320603 0
Government body
Name [1] 320603 0
Gandaki Province Academy of Science and Technology (GPAST)
Address [1] 320603 0
Country [1] 320603 0
Nepal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316863 0
Institutional Review Committee (IRC), Pokhara University
Ethics committee address [1] 316863 0
Ethics committee country [1] 316863 0
Nepal
Date submitted for ethics approval [1] 316863 0
29/12/2024
Approval date [1] 316863 0
05/01/2025
Ethics approval number [1] 316863 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139238 0
Mr Abhishek Sapkota
Address 139238 0
Pokhara University, Pokhara-30, Dhungepatan, 33700, Gandaki Province
Country 139238 0
Nepal
Phone 139238 0
+9779846606522
Fax 139238 0
Email 139238 0
[email protected]
Contact person for public queries
Name 139239 0
Abhishek Sapkota
Address 139239 0
Pokhara University, Pokhara-30, Dhungepatan, 33700, Gandaki Province
Country 139239 0
Nepal
Phone 139239 0
+9779846606522
Fax 139239 0
Email 139239 0
[email protected]
Contact person for scientific queries
Name 139240 0
Abhishek Sapkota
Address 139240 0
Pokhara University, Pokhara-30, Dhungepatan, 33700, Gandaki Province
Country 139240 0
Nepal
Phone 139240 0
+9779846606522
Fax 139240 0
Email 139240 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data (IPD) for this trial will not be available due to ethical and privacy considerations.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.