Cervical Cancer ScreeningCOBIN-CNCT03808064
Community-based Intervention for Cervical Cancer Screening Uptake in Nepal
A study testing FCHV home visit in people with Cervical Cancer Screening, run by University of Aarhus at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- FCHV home visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteNepal
- Study dates
- 17 Apr 2019to 26 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women of age group 30-60 years who were recruited in the COBIN Wave I survey
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Cervical Cancer Screening
- Being tested
- FCHV home visit
- Keywords
- Cervical cancer screening, Community health worker, Community-based, Female community health volunteers, Non-communicable diseases, Randomized controlled trial, Nepal
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCHV home visitBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FCHV home visit |
| Control arm | No intervention | There won't be any intervention in the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start17 Apr 2019
- Primary completion26 Dec 2020
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aamod Dhoj Shrestha, University of Aarhus
- Investigators
- Aamod D Shrestha, MPH, Principal investigator, Department of Public Health, Aarhus University, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808064
- Sponsor's protocol ID
- ADS18
- Acronym
- COBIN-C
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36161136Shrestha 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.
PubMed 33499911
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03808064
- Acronym / sponsor ID
- COBIN-C / ADS18
- Conditions
- Cervical Cancer Screening
- Keywords
- Cervical cancer screening, Community health worker, Community-based, Female community health volunteers, Non-communicable diseases, Randomized controlled trial, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: FCHV home visitAfter 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. |
| Control arm | No intervention | –There won't be any intervention in the control arm. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women of age group 30-60 years who were recruited in the COBIN Wave I survey
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCHV home visitBehavioral: FCHV visit Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages Other Name: FCHV Home Visit | Behavioural | Intervention arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 36161136Dhoj 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.
- Derived from this study: PubMed 33499911Shrestha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aamod D Shrestha, MPH principal investigator
Department of Public Health, Aarhus University, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCHV home visit in people with Cervical Cancer Screening, run by University of Aarhus at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The increase in the number of participants attending cervical cancer screening after education intervention (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.