Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

NCT03808064CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

690

Start Date

2019-04-17

Completion Date

2020-12-26

Study Type

INTERVENTIONAL

Official Title

Community-based Intervention for Cervical Cancer Screening Uptake in a Semi-urban Area of Pokhara Metropolitan, Nepal: A Cluster Randomized Controlled Trial (COBIN-C)

Interventions

FCHV home visit

Conditions

Cervical Cancer Screening

Eligibility

Age Range

30 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

* All women of age group 30-60 years who were recruited in the COBIN Wave I survey

Exclusion Criteria:

* Women who are not able to give consent
* Severely ill,
* Pregnant or less than 6 weeks after delivery,
* Who is already diagnosed with cervical pre-cancer and cancer
* With a history of total hysterectomy
* Who are reluctant to participate in the study or unable to complete the interview

Outcome Measures

Primary Outcomes

The increase in the number of participants attending cervical cancer screening after education intervention

The effect of Female Community Health Volunteers led community based educational intervention through home visits for increasing cervical cancer screening uptake will be evaluated by comparing the baseline with follow up study.

Time frame: One year

Locations

Nepal Development Society, Pokhara, Nepal

Linked Papers

2021-01-26

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-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.

Linked Investigators