Clinical trial NCT03808064: Community-based Intervention for Cervical Cancer Screening Uptake in Nepal
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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Keywords: Cervical cancer screening
Community health worker
Community-based
Female community health volunteers
Non-communicable diseases
Randomized controlled trial
Nepal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 690
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The increase in the number of participants attending cervical cancer screening after education intervention
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Nepal Development Society
state: Gandaki
Study officials:
affiliation: Department of Public Health, Aarhus University, Aarhus, Denmark
name: Aamod D Shrestha, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.