COBIN-C: Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT03808064

Collaborator

(none)

690

Enrollment

Location

Arms

20.3

Actual Duration (Months)

33.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Screening	Behavioral: FCHV home visit	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

690 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Apr 17, 2019

Actual Primary Completion Date :

Dec 26, 2020

Actual Study Completion Date :

Dec 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm After randomization, the FCHVs in the intervention arm will receive training, health education materials and a recording register. After receiving training, they will educate women of their respective ward on cervical cancer screening and prevention through home visits and maintain records in their service register.	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
No Intervention: Control arm There won't be any intervention in the control arm.

Arm

Intervention/Treatment

Experimental: Intervention arm

After randomization, the FCHVs in the intervention arm will receive training, health education materials and a recording register. After receiving training, they will educate women of their respective ward on cervical cancer screening and prevention through home visits and maintain records in their service register.

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

No Intervention: Control arm

There won't be any intervention in the control arm.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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