Cervical CancerNCT03281135
Optimizing Cervical Cancer Screening Modalities
A study testing HPV testing in people with Cervical Cancer, run by Addis Ababa University.
Trial summary
This project aims to optimize cervical cancer screening adherence comparing Arm A (VIA) and Arm B self-sampled Human Papilloma Virus (HPV) testing and determine the molecular epidemiology of HPV, persistence level and identify factors responsible for persistence, and also characterizing the potential dysplasia by… Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to May 2019
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 30 and 49
Who cannot join
- women with History of hysterectomy or cervical cancer, pregnant women, not meet the eligibility criteria and unable to give consent.
About this study
Official title: Optimizing Cervical Cancer Screening Modalities and Identifying the Molecular Epidemiology of Human Papilloma Virus in Ethiopia: A Cluster Randomized Trial
This project aims to optimize cervical cancer screening adherence comparing Arm A (VIA) and Arm B self-sampled Human Papilloma Virus (HPV) testing and determine the molecular epidemiology of HPV, persistence level and identify factors responsible for persistence, and also characterizing the potential dysplasia by biomarkers that describe the disease stage in a population of Ethiopia.
A cluster-randomized trial will be used in this study. The total number of ten kebele's(Smallest administrative unit) will be randomly classified in to two arms(VIA and HPV+VIA).Community health workers will be used as a cluster for randomization. Community sensitization and awareness creation will be performed at health facilities and in communities at social, business or religious gatherings, about cervical cancer and its prevention for eligible women in both arms. Women will be educated about cervical cancer and advice for testing at the Hospital offering VIA (arm A). Women will also be instructed to undergo HPV self-sampling at nearby health posts with a vaginal evalyn brush (arm B). All eligible women on each cluster will be included in the study at both arms. Based on the community health workers number and structure study area there will be about 22 clusters with 80 eligible women on each cluster. Brushes will be sent to the Microbiology Laboratory of Department of Microbiology,Immunology and Parasitology,College of Health Sciences, Addis Ababa University, Addis Ababa, where the laboratory service is sated-up . Trained Microbiologists will perform the laboratory analysis at the HPV laboratory. Only women with samples positive for high-risk HPV (hrHPV) will be contacted and informed to go to the Hospital offering VIA. Further tests will also be performed from the brushes at the collaborators' HPV laboratory, Germany to better characterize the dysplesia.
The women found positive for VIA or hrHPV+VIA will receive cryo treatment at Butajira Hospital. To evaluate the long-term effect and factors for persistence, all eligible women within the catchment area will be visited after 2 years door to-door and asked for a vaginal self-sample and HPV-genotype test. The impact of intervention, factors associated with HPV infection, persistence, clearance, and adherence to the screening service will be seen.
Read the detailed description
Cervical cancer is the second most common cancer in women worldwide but the commonest in developing countries. In Ethiopia, cervical cancer is the leading cause of morbidity and mortality from all cancers. The Human Papilloma Viruses (HPV) is a necessary cause for cervical cancer (CC). HPVs 16, 18, 31, 33, 35 and 39 are considered as high risk types which are mainly responsible in cervical carcinogenesis.
In developing countries, including Ethiopia, almost all women with cancers present to health care facilities at late stages with advanced disease and poor prognosis. Unlike other reproductive health cancers, cervical cancer can be prevented and even possible to be cured if identified in its early stages. Currently cervical cancer screening by visual inspection with acetic acid (VIA) and immediate treatment with cryotherapy is recommended by World Health Organization(WHO) for low and middle income countries as this method does not require especially trained professionals and more resources and results are available immediately which reduces the attrition rate. However, yet accessing VIA is difficult for many rural women as the service is only available at least at district Hospital level in very few places. Although VIA is accepted by the government in many low income countries, training , maintaining quality assurance, the invasiveness of a pelvic examination and user variability of the test remain critical barriers. Moreover, the short comings of this method includes having of low positive predictive value and lack of evidence on periodic screening performance.
Detection of High risk Human Papilloma Viruses (HrHPV) in the cervix has been recommended in settings wherever possible. World Health Organization (WHO) primarily recommends the HPV test which is very sensitive and a convenient molecular test for cervical cancer screening. This approach is found to be less examiner-dependent, reduce the burden in health system, enhance the accuracy, efficiency and reduce cultural barriers. Therefore, HPV test might be a future option in low and middle income countries.
In Ethiopia, screening with VIA followed by cryotherapy started in 2009 first for women with HIV in selected 14 hospitals and subsequently the service was expanded to 10 additional health institution. Currently the federal ministry of health in Ethiopia has scaled up the service to the general public into public health facilities. However, still majority of women in Ethiopia are residing in rural area where access to screening and treatment facilities is limited or lacking.
So far few studies have been conducted in African settings for assessing the uptake and acceptability of independent screening approaches. Study in Sub Saharan Africa reported higher acceptance of HPV based cervical cancer screening than visual inspection with acetic acid. In Ethiopia there is no adequate information on women uptake, acceptability, adherence and potential barriers of cervical cancer screening for different screening modalities. Moreover, data on HPV prevalence and genotype distribution are rare.
- Conditions
- Cervical Cancer
- Being tested
- HPV testing
- Keywords
- Cervical cancer screening, Adherance, HPV typing, HDSS, Ethiopia
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testingOther
Clusters randomly allocated to this arm of the study will be sensitized to be showed up in nearby health posts for self sampling with Evalyn brush for HPV testing.
| Study group | Role | What they receive |
|---|---|---|
| HPV testing | Other | This is an experimental arm for the primary outcome, 'adherence to the procedures'. In this group self sampling will be done using the Evalyn brush for HPV testing. Receives: Other: HPV testing |
| Standard care: VIA screening | No intervention | Control Arm, in which women's are invited to cervical cancer screening as per standard Ethiopian cervical cancer prevention and control guideline. Uptake of screening in this group will be compared with the HPV testing arm group to test for significant differences in adherence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the procedures
Proportions of women who adhered in the screening and subsequent follow up based on HPV testing using self-sampling versus an offer of attending for a VIA.
This will be compared based on: A women who accessed the HPV self sampling at health post and accessed VIA and treated for positive result plus untreated for negative result divided by the eligible women in the arm versus A women who accessed the VIA at health facility and treated for positive result plus untreated for negative result divided by the eligible women in the arm.
Measured: With in 1 year period
Secondary outcomes (3)
Number of women that participate in Cervical Cancer Screening in the control (VIA) compared with the number of women that participate in the intervention(Self sampling HPV testing)
This will be measured based on the number of women who attended only the screening procedure after the first sensitization program
Measured: With in 1 year period
Demographic and socio cultural factors associated with uptake and adherence of two different cervical cancer screening procedures
Here we will try to identify and explore socio economic and cultural barriers related with each screening approach.
Measured: With in 1 year period
HPV genotypes among rural women
We will identify HPV genotypes from all collected samples of the study population. Samples will be collected from the community and analyzed centrally in Addis Ababa.
Measured: With in 1 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startJan 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized trial will be conducted in the Health and Demographic Surveillance Site (HDSS) of Addis Ababa University, School of Public Health which is located in Butajira district. The study population consists of women aged 30-49 who are found among the catchment population of ten Kebele's(Smallest Administrative Unit). Each Kebele will have 2 or more clusters based on the community health workers structure and size. A total of 22 clusters will then be randomized in to two arms. A total of 1760 women will be grouped in to 22 clusters, each comprises 80 women.
- Masking
- None (open label)
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Muluken Gizaw Turago, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281135
- Sponsor's protocol ID
- 058/17/SPH
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will see
Publications
Teka B, Gizaw M, Firdawoke E, Addissie A, Sisay TA, Schreckenberger C, Skof AS, Thies S, Mihret A, Kantelhardt EJ, Abebe T, Kaufmann AM. A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia. Cancer Manag Res. 2022 Jul 29;14:2253-2263. doi: 10.2147/CMAR.S360712. eCollection 2022.
PubMed 35937937
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cervical Cancer Screening Modalities and Identifying the Molecular Epidemiology of Human Papilloma Virus in Ethiopia: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03281135
- Acronym / sponsor ID
- 058/17/SPH
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer screening, Adherance, HPV typing, HDSS, Ethiopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Charite University, Berlin, Germany
- Study start
- Jan 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 13 Sep 2017 (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 project aims to optimize cervical cancer screening adherence comparing Arm A (VIA) and Arm B self-sampled Human Papilloma Virus (HPV) testing and determine the molecular epidemiology of HPV, persistence level and identify factors responsible for persistence, and also characterizing the potential dysplasia by biomarkers that describe the disease stage in a population of Ethiopia.
A cluster-randomized trial will be used in this study. The total number of ten kebele's(Smallest administrative unit) will be randomly classified in to two arms(VIA and HPV+VIA).Community health workers will be used as a cluster for randomization. Community sensitization and awareness creation will be performed at health facilities and in communities at social, business or religious gatherings, about cervical cancer and its prevention for eligible women in both arms. Women will be educated about cervical cancer and advice for testing at the Hospital offering VIA (arm A). Women will also be instructed to undergo HPV self-sampling at nearby health posts with a vaginal evalyn brush (arm B). All eligible women on each cluster will be included in the study at both arms. Based on the community health workers number and structure study area there will be about 22 clusters with 80 eligible women on each cluster. Brushes will be sent to the Microbiology Laboratory of Department of Microbiology,Immunology and Parasitology,College of Health Sciences, Addis Ababa University, Addis Ababa, where the laboratory service is sated-up . Trained Microbiologists will perform the laboratory analysis at the HPV laboratory. Only women with samples positive for high-risk HPV (hrHPV) will be contacted and informed to go to the Hospital offering VIA. Further tests will also be performed from the brushes at the collaborators' HPV laboratory, Germany to better characterize the dysplesia.
The women found positive for VIA or hrHPV+VIA will receive cryo treatment at Butajira Hospital. To evaluate the long-term effect and factors for persistence, all eligible women within the catchment area will be visited after 2 years door to-door and asked for a vaginal self-sample and HPV-genotype test. The impact of intervention, factors associated with HPV infection, persistence, clearance, and adherence to the screening service will be seen.
Detailed description
Cervical cancer is the second most common cancer in women worldwide but the commonest in developing countries. In Ethiopia, cervical cancer is the leading cause of morbidity and mortality from all cancers. The Human Papilloma Viruses (HPV) is a necessary cause for cervical cancer (CC). HPVs 16, 18, 31, 33, 35 and 39 are considered as high risk types which are mainly responsible in cervical carcinogenesis.
In developing countries, including Ethiopia, almost all women with cancers present to health care facilities at late stages with advanced disease and poor prognosis. Unlike other reproductive health cancers, cervical cancer can be prevented and even possible to be cured if identified in its early stages. Currently cervical cancer screening by visual inspection with acetic acid (VIA) and immediate treatment with cryotherapy is recommended by World Health Organization(WHO) for low and middle income countries as this method does not require especially trained professionals and more resources and results are available immediately which reduces the attrition rate. However, yet accessing VIA is difficult for many rural women as the service is only available at least at district Hospital level in very few places. Although VIA is accepted by the government in many low income countries, training , maintaining quality assurance, the invasiveness of a pelvic examination and user variability of the test remain critical barriers. Moreover, the short comings of this method includes having of low positive predictive value and lack of evidence on periodic screening performance.
Detection of High risk Human Papilloma Viruses (HrHPV) in the cervix has been recommended in settings wherever possible. World Health Organization (WHO) primarily recommends the HPV test which is very sensitive and a convenient molecular test for cervical cancer screening. This approach is found to be less examiner-dependent, reduce the burden in health system, enhance the accuracy, efficiency and reduce cultural barriers. Therefore, HPV test might be a future option in low and middle income countries.
In Ethiopia, screening with VIA followed by cryotherapy started in 2009 first for women with HIV in selected 14 hospitals and subsequently the service was expanded to 10 additional health institution. Currently the federal ministry of health in Ethiopia has scaled up the service to the general public into public health facilities. However, still majority of women in Ethiopia are residing in rural area where access to screening and treatment facilities is limited or lacking.
So far few studies have been conducted in African settings for assessing the uptake and acceptability of independent screening approaches. Study in Sub Saharan Africa reported higher acceptance of HPV based cervical cancer screening than visual inspection with acetic acid. In Ethiopia there is no adequate information on women uptake, acceptability, adherence and potential barriers of cervical cancer screening for different screening modalities. Moreover, data on HPV prevalence and genotype distribution are rare.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized trial will be conducted in the Health and Demographic Surveillance Site (HDSS) of Addis Ababa University, School of Public Health which is located in Butajira district. The study population consists of women aged 30-49 who are found among the catchment population of ten Kebele's(Smallest Administrative Unit). Each Kebele will have 2 or more clusters based on the community health workers structure and size. A total of 22 clusters will then be randomized in to two arms. A total of 1760 women will be grouped in to 22 clusters, each comprises 80 women.
| Arm | Type | Receives |
|---|---|---|
| HPV testing | Other | Other: HPV testingThis is an experimental arm for the primary outcome, 'adherence to the procedures'. In this group self sampling will be done using the Evalyn brush for HPV testing. |
| Standard care: VIA screening | No intervention | –Control Arm, in which women's are invited to cervical cancer screening as per standard Ethiopian cervical cancer prevention and control guideline. Uptake of screening in this group will be compared with the HPV testing arm group to test for significant differences in adherence. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged between 30 and 49
Key exclusion criteria (1 listed)
- women with History of hysterectomy or cervical cancer, pregnant women, not meet the eligibility criteria and unable to give consent.
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 |
|---|---|---|
| HPV testingClusters randomly allocated to this arm of the study will be sensitized to be showed up in nearby health posts for self sampling with Evalyn brush for HPV testing. | Other | HPV testing |
Primary outcome
Adherence to the procedures
Time frame: With in 1 year period
Proportions of women who adhered in the screening and subsequent follow up based on HPV testing using self-sampling versus an offer of attending for a VIA. This will be compared based on: A women who accessed the HPV self sampling at health post and accessed VIA and treated for positive result plus untreated for negative result divided by the eligible women in the arm versus A women who accessed the VIA at health facility and treated for positive result plus untreated for negative result divided by the eligible women in the arm.
3 secondary outcomes
Number of women that participate in Cervical Cancer Screening in the control (VIA) compared with the number of women that participate in the intervention(Self sampling HPV testing)
Time frame: With in 1 year period
Demographic and socio cultural factors associated with uptake and adherence of two different cervical cancer screening procedures
Time frame: With in 1 year period
HPV genotypes among rural women
Time frame: With in 1 year period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 35937937Teka B, Gizaw M, Firdawoke E, Addissie A, Sisay TA, Schreckenberger C, Skof AS, Thies S, Mihret A, Kantelhardt EJ, Abebe T, Kaufmann AM. A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia. Cancer Manag Res. 2022 Jul 29;14:2253-2263. doi: 10.2147/CMAR.S360712. eCollection 2022.
- Individual participant dataSharing planned: Undecided. We will see
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HPV testing in people with Cervical Cancer, run by Addis Ababa University.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Adherence to the procedures (time frame: With in 1 year period). 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 NCT03281135, which also lists 1 linked publication.
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 13 Sep 2017.