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尼泊尔博克拉都会区半城市地区基于社区的宫颈癌筛查参与度干预(COBIN-C):一项整群随机对照试验的研究方案。

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.

机构信息

Center for Global Health, Department of Public Health, Aarhus University, Aarhus, Denmark.

COBIN, Nepal Development Society, Bharatpur, Nepal.

出版信息

Trials. 2021 Jan 26;22(1):94. doi: 10.1186/s13063-021-05049-3.

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-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 modeled 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.

摘要

背景

先前的研究表明,旨在增加宫颈癌筛查的健康干预措施已被证明可有效降低宫颈癌的发病率和死亡率。本研究旨在确定由经过培训的女性社区卫生志愿者(FCHVs)实施的基于家庭的健康教育干预对增加宫颈癌筛查率的效果,FCHVs 是尼泊尔社区卫生工作者的一种类别。

方法

这是一项基于社区的、开放性标签的、两臂的、集群随机试验[七个集群(地理行政区)被随机分为干预组和对照组]。参与者是从一项基于人群的调查中招募的,样本量为 884 人。根据人口比例,将招募 277 名女性进入干预组,413 名女性进入对照组。将动员 FCHVs 开展基于健康信念模型的为期 12 个月的社区健康教育干预。该研究的主要结局指标是两组之间宫颈癌筛查率的差异。主要结局将通过混合效应逻辑回归分析进行建模。

讨论

COBIN-C 是第一项研究,调查了 FCHVs 开展的基于社区的健康教育干预对提高尼泊尔妇女宫颈癌筛查率的效果。本研究的目的是制定并实施一个基于家庭的、具有文化敏感性的方案,以提高社区一级的宫颈癌筛查覆盖率。

试验注册

ClinicalTrials.gov NCT03808064。于 2019 年 1 月 14 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c24/7836185/123e8b7d7940/13063_2021_5049_Fig1_HTML.jpg

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