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

Abstract

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-basedsurvey with a sample size of 884. Based on population proportionsize, 277women 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 outcomemeasure 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 purposeof 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.govNCT03808064. Registered on January 14, 2019. (https://clinicaltrials.gov/ct2/show/NCT03808064).