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
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).
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This is a list of supplementary files associated with this preprint. Click to download.
Additional file 1: SPIRIT 2013 Checklist: COBIN-C
Additional file 2: Questionnaire: COBIN-C
Posted 13 Jan, 2021
Received 10 Jan, 2021
Invitations sent on 07 Jan, 2021
On 07 Jan, 2021
On 28 Dec, 2020
On 28 Dec, 2020
Received 04 Sep, 2020
On 02 Sep, 2020
Invitations sent on 28 Jul, 2020
On 18 Jul, 2020
On 19 May, 2020
On 16 May, 2020
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
Posted 13 Jan, 2021
Received 10 Jan, 2021
Invitations sent on 07 Jan, 2021
On 07 Jan, 2021
On 28 Dec, 2020
On 28 Dec, 2020
Received 04 Sep, 2020
On 02 Sep, 2020
Invitations sent on 28 Jul, 2020
On 18 Jul, 2020
On 19 May, 2020
On 16 May, 2020
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