Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

Cervical Cancer Screening Clinical Trial

— COBIN-C  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808064
• Other study ID #: ADS18
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: December 26, 2020

Study information

• Verified date: December 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: December 26, 2020
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• FCHV home visit
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

Locations

Country	Name	City	State
Nepal	Nepal Development Society	Pokhara	Gandaki

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year