NCT03808064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
690

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2020

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

January 10, 2019

Last Update Submit

December 2, 2021

Conditions

Keywords

Cervical cancer screeningCommunity health workerCommunity-basedFemale community health volunteersNon-communicable diseasesRandomized controlled trialNepal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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

Interventions

FCHV home visitBEHAVIORAL

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

Intervention arm

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women of age group 30-60 years who were recruited in the COBIN Wave I survey

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepal Development Society

Pokhara, Gandaki, 33700, Nepal

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aamod D Shrestha, MPH

    Department of Public Health, Aarhus University, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Fellow

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 17, 2019

Study Start

April 17, 2019

Primary Completion

December 26, 2020

Study Completion

December 26, 2020

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations