Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-29 @ 6:30 AM
Study NCT ID:
NCT03281135
Status:
UNKNOWN
Last Update Posted:
2017-09-13
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Cervical Cancer Screening Modalities
Sponsor:
Addis Ababa University
Organization:
Study Overview
Official Title:
Optimizing Cervical Cancer Screening Modalities and Identifying the Molecular Epidemiology of Human Papilloma Virus in Ethiopia: A Cluster Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: