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Study protocol
Community-based intervention for cervical cancer screening uptake in a semi-urban area of Pokhara Metropolitan, Nepal (COBIN-C): Study protocol for a cluster-randomized controlled trial
Aamod Dhoj Shrestha
Nepal Development Society
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8548-9498
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Previous studies suggest that health intervention designed to increase cervical cancer screening has been effective to reduce cervical cancer incidence and mortality. The aim of this study is to determine the effect of a home-based health education intervention for increasing cervical cancer screening uptake delivered by trained Female Community Health Volunteers (FCHVs), a category of community health worker in Nepal.
Methods: A community-based, open-label, two-armed, cluster-randomized trial [seven clusters (geographical wards) randomized for the intervention, and seven for the control arm]. The participants are recruited from a population-based survey with a sample size of 884. Based on population proportion size, 277 women will be recruited for the intervention group and 413 women recruited for the control group. A 12-month community-based health education intervention will be administered mobilizing the FCHVs, based on the Health Belief Model. The primary outcome measure of the study will be the difference in percentage of cervical cancer screening uptake between the two study arms. The primary outcomes will be modelled by using mixed-effect logistic regression analysis.
Discussion: COBIN-C is the first study investigating the effect of a community-based health education intervention by FCHVs on increasing cervical cancer screening uptake among women in Nepal. The purpose of this study is to develop and implement a home-based, culturally sensitive program to increase cervical cancer screening coverage at the community level.
Trial registration: ClinicalTrials.gov NCT03808064. Registered on January 14, 2019. (https://clinicaltrials.gov/ct2/show/NCT03808064).
Keywords
Female community health volunteers, community health worker, non-communicable diseases, cervical cancer screening, community-based, randomized controlled trial, Nepal
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1SPIRIT2013ChecklistCOBINC.pdf
Additional file 1: SPIRIT 2013 Checklist: COBIN-C
- Additionalfile2QuestionnaireCOBINC.pdf
Additional file 2: Questionnaire: COBIN-C
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Community-based intervention for cervical cancer screening uptake in a semi-urban area of Pokhara Metropolitan, Nepal (COBIN-C): Study protocol for a cluster-randomized controlled trial
Aamod Dhoj Shrestha
Nepal Development Society
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8548-9498
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 13 Jan, 2021
No community comments so far
Review #1 received
Received 10 Jan, 2021
Reviewers invited
Invitations sent on 07 Jan, 2021
Reviewer #1 agreed
On 07 Jan, 2021
Editor assigned
On 28 Dec, 2020
Submission checks complete
On 28 Dec, 2020
No comments provided
Review #1 received
Received 04 Sep, 2020
Reviewer #1 agreed
On 02 Sep, 2020
Reviewers invited
Invitations sent on 28 Jul, 2020
Editor assigned
On 18 Jul, 2020
Submission checks complete
On 19 May, 2020
First submitted
On 16 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Previous studies suggest that health intervention designed to increase cervical cancer screening has been effective to reduce cervical cancer incidence and mortality. The aim of this study is to determine the effect of a home-based health education intervention for increasing cervical cancer screening uptake delivered by trained Female Community Health Volunteers (FCHVs), a category of community health worker in Nepal.
Methods: A community-based, open-label, two-armed, cluster-randomized trial [seven clusters (geographical wards) randomized for the intervention, and seven for the control arm]. The participants are recruited from a population-based survey with a sample size of 884. Based on population proportion size, 277 women will be recruited for the intervention group and 413 women recruited for the control group. A 12-month community-based health education intervention will be administered mobilizing the FCHVs, based on the Health Belief Model. The primary outcome measure of the study will be the difference in percentage of cervical cancer screening uptake between the two study arms. The primary outcomes will be modelled by using mixed-effect logistic regression analysis.
Discussion: COBIN-C is the first study investigating the effect of a community-based health education intervention by FCHVs on increasing cervical cancer screening uptake among women in Nepal. The purpose of this study is to develop and implement a home-based, culturally sensitive program to increase cervical cancer screening coverage at the community level.
Trial registration: ClinicalTrials.gov NCT03808064. Registered on January 14, 2019. (https://clinicaltrials.gov/ct2/show/NCT03808064).
Figure 1