search
Back to results

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

Primary Purpose

Cervical Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
FCHV home visit
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer Screening focused on measuring Cervical cancer screening, Community health worker, Community-based, Female community health volunteers, Non-communicable diseases, Randomized controlled trial, Nepal

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nepal Development Society

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
December 2, 2021
Sponsor
University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT03808064
Brief Title
Community-based Intervention for Cervical Cancer Screening Uptake in Nepal
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 26, 2020 (Actual)
Study Completion Date
December 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening
Keywords
Cervical cancer screening, Community health worker, Community-based, Female community health volunteers, Non-communicable diseases, Randomized controlled trial, Nepal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
690 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
There won't be any intervention in the control arm.
Intervention Type
Behavioral
Intervention Name(s)
FCHV home visit
Intervention Description
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 Outcome Measure Information:
Title
The increase in the number of participants attending cervical cancer screening after education intervention
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aamod D Shrestha, MPH
Organizational Affiliation
Department of Public Health, Aarhus University, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepal Development Society
City
Pokhara
State/Province
Gandaki
ZIP/Postal Code
33700
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36161136
Citation
Dhoj Shrestha A, Gyawali B, Shrestha A, Shrestha S, Neupane D, Ghimire S, Campbell C, Kallestrup P. Effect of a female community health volunteer-delivered intervention to increase cervical cancer screening uptake in Nepal: a cluster randomized controlled trial. Prev Med Rep. 2022 Aug 12;29:101948. doi: 10.1016/j.pmedr.2022.101948. eCollection 2022 Oct.
Results Reference
derived
PubMed Identifier
33499911
Citation
Shrestha AD, Neupane D, Ghimire S, Campbell C, Kallestrup P. 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. Trials. 2021 Jan 26;22(1):94. doi: 10.1186/s13063-021-05049-3.
Results Reference
derived

Learn more about this trial

Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

We'll reach out to this number within 24 hrs