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Clinical Trials/NCT03808064
NCT03808064
Completed
Not Applicable

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

University of Aarhus1 site in 1 country690 target enrollmentApril 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer Screening
Sponsor
University of Aarhus
Enrollment
690
Locations
1
Primary Endpoint
The increase in the number of participants attending cervical cancer screening after education intervention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led community-based educational intervention through home visits increasing cervical cancer screening uptake.

Detailed Description

Cervical cancer is the major cause of cancer deaths among women in Nepal. Screening is one of the most effective tools for early diagnosis, prevention, and treatment. However, skilled health professionals and tools available for cervical cancer screening are limited in low and middle-income countries (LMICs) including Nepal. The World Health Organization (WHO) and Alliance for Cervical Cancer Prevention (ACCP) recommends that countries, areas, or institutions seeking to initiate or strengthen cervical cancer screening programs should consider introducing or expanding Visual Inspection with Acetic acid (VIA) until more appropriate and affordable HPV-based tests become available. 'National Guideline for Cervical Cancer Screening and Prevention in Nepal, 2010' includes VIA as a screening method for cervical cancer. Current studies reveal Nepalese women's participation in cervical cancer screening is low. Thus, there is a need for appropriate, cost-effective and sustainable interventions to increase VIA screening uptake at the primary health care level across Nepal. The primary objective of this study is to evaluate the effect of a Female Community Health Volunteer (FCHV) led community-based educational intervention through home visits increasing cervical cancer screening uptake. The primary outcome of the study is to increase the cervical cancer-screening uptake in the intervention group. This will be the first community-based cluster-randomized trial designed to mobilize FCHVs for increasing cervical cancer screening uptake in Nepal.

Registry
clinicaltrials.gov
Start Date
April 17, 2019
End Date
December 26, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aamod Dhoj Shrestha

PhD Fellow

University of Aarhus

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: One year

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.

Study Sites (1)

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