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Completed

NCT Number: NCT03808064

Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nepal Development Society

Pokhara, Gandaki, 33700, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FCHV home visit

Behavioral

Behavioral: FCHV visit Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages Other Name: FCHV Home Visit

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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)

Acronym: COBIN-C

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 17, 2019
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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