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

University of Aarhus

Status: Completed

Conditions: Cervical Cancer Screening

Treatments: Behavioral: FCHV home visit

Study type: Interventional

Funder types: Other

Identifiers

NCT03808064

ADS18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 690 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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690 participants in 2 patient groups

Intervention arm

Experimental group

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.

Treatment:

Behavioral: FCHV home visit

Control arm

No Intervention group

Description:

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