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Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

NCT ID: NCT03808064

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-17

Study Completion Date

2020-12-26

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Screening

Keywords

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Cervical cancer screening Community health worker Community-based Female community health volunteers Non-communicable diseases Randomized controlled trial Nepal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FCHV home visit

Intervention Type 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

Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Aamod Dhoj Shrestha

PhD Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aamod D Shrestha, MPH

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health, Aarhus University, Aarhus, Denmark

Locations

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Nepal Development Society

Pokhara, Gandaki, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type DERIVED
PMID: 36161136 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33499911 (View on PubMed)

Other Identifiers

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ADS18

Identifier Type: -

Identifier Source: org_study_id