Community-based Intervention for Cervical Cancer Screening Uptake in Nepal (COBIN-C)
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| ClinicalTrials.gov Identifier: NCT03808064 |
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Recruitment Status :
Completed
First Posted : January 17, 2019
Last Update Posted : December 17, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Cancer Screening | Behavioral: FCHV home visit | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 690 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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) |
| Actual Study Start Date : | April 17, 2019 |
| Actual Primary Completion Date : | December 26, 2020 |
| Actual Study Completion Date : | December 26, 2020 |
| Arm | Intervention/treatment |
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Experimental: 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.
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Behavioral: 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 |
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No Intervention: Control arm
There won't be any intervention in the control arm.
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- The increase in the number of participants attending cervical cancer screening after education intervention [ Time Frame: One year ]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.
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| Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808064
| Nepal | |
| Nepal Development Society | |
| Pokhara, Gandaki, Nepal, 33700 | |
| Principal Investigator: | Aamod D Shrestha, MPH | Department of Public Health, Aarhus University, Aarhus, Denmark |
| Responsible Party: | Aamod Dhoj Shrestha, PhD Fellow, University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT03808064 |
| Other Study ID Numbers: |
ADS18 |
| First Posted: | January 17, 2019 Key Record Dates |
| Last Update Posted: | December 17, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cervical cancer screening Community health worker Community-based Female community health volunteers |
Non-communicable diseases Randomized controlled trial Nepal |
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Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |