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Metrics details. The causal relationship between high-risk hr HPV infection and precancerous lesions or cervical cancer has led to the development of strategies to increase screening performance and prevent this cancer.

Cervical cancer screening in Brazil is opportunistic, and this cancer remains a considerable health problem with a high proportion of diagnoses in advanced stages. All women with a negative test will be reassessed after five years. Those showing the other 12 hr-HPV types will be tested by cytology, and if any abnormality is detected, they will also be referred for colposcopy.

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The histopathologic evaluation will be reviewed by a pathologist panel and aided by p16 immunohistochemistry. A cost-effectiveness analysis will be performed by a Markov model comparing the cost of the new program and the screening performed by conventional cytology five years prior — The new screening program is considered a breakthrough for public health regarding cervical cancer, which is the third leading cause of cancer death among Brazilian women.

The proposed program will provide a modern cervical cancer screening method for women, and information about cost-effectiveness will help other similar places support the decision of implementing cervical cancer screening using the DNA-HPV test. Peer Review reports. Cervical cancer remains a major health problem, especially in developing countries such as Brazil [ 12 ]. The widespread knowledge that cervical cancer is caused by persistent high-risk human papillomavirus hr-HPV infection has resulted in the development of biomolecular tests and alternative strategies for cervical preneoplastic lesion screening.

Cytology-based cervical cancer screening e. Papanicolaou testcolposcopy and histological diagnosis followed by the treatment of cervical intraepithelial neoplasms CINs have been widely used worldwide.

Cervical cancer screening program based on primary dna-hpv testing in a brazilian city: a cost-effectiveness study protocol

Cervical cancer mortality reduction has been observed in high income and some middle-income countries, especially in those that have established successfully organized cancer prevention programs [ 34 ]. However, in low- and middle-income countries, the success of screening is hampered by many factors, such as low cytology sensitivity, requiring frequent repetition to achieve longitudinal sensitivity, low coverage of the target population at regular intervals, and poor quality control of cytology services [ 34 ].

These factors promote the search for alternative strategies, such as HPV molecular testing.

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Several randomized clinical trials and prospective studies from the early s to the present have shown the superiority of DNA-HPV testing to detect high-grade squamous intraepithelial lesions HSILsadenocarcinoma in situ AIS and early cervical cancer when compared to cervical cytology [ 56789 ]. These would reduce the total of tests performed, affecting costs. Some studies have provided strong evidence for the adoption of the DNA-HPV test in cervical cancer screening [ 11121314 ].

Cervical cancer is the third most common cancer among women in Brazil, with an estimated 16, new cases in [ 18 ].

Besides, there is a large proportion of cases diagnosed at advanced stages, most of them managed at Public Health System [ 2122 ]. These factors highlight the need for reassessment of the cervical cancer screening program currently in place in Brazil.

This is a longitudinal study involving women from Indaiatuba Sao Paulo State, Brazilan urban city with a population ofpeople and a high 0. The target women are women relying only on public health services SUS — Unified Health System and candidates for cervical cancer screening.

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In Brazil, health care is free of charge to every citizen, although some people co-use private services. Therefore, the target SUS population was 31,women for the new program. The organization of the CCSP-HPV implies developing strategies to reach higher target population coverage, evaluate the compliance of the staff to the program, and research to evaluate the cost-effectiveness.

For comparison, a similar population from the same city that performed routine cytology screening from tofive years before CCSP-HPV will be the reference for comparison of cost-effectiveness evaluation.

All women from Indaiatuba that underwent cytology tests by SUS from to The tests and laboratory will be the same for the entire five-year period planned for the study. Briefly, the procedures are as follows:. The collection of cervical samples will be performed in the routine of care at 18 primary health care units in Indaiatuba. The cervical sample will be collected using a brush, and the sample will be stored in a ly identified vial containing preservative medium specific for the HPV test PreservCyt, ThinPrep — Hologic, Inc.

All procedures related to sample collection, storage, and transportation to the HPV testing laboratory are similar to those used in cytology screening, except for sample slides conventional cytology replaced for liquid-based cytology LBC vials. All primary health care units will be informed about CCSP-HPV guidelines on the collection, storage, and transportation of samples, which will be primarily sent to a central unit in the city and from there to the HPV testing laboratory.

This sample transport is planned to take place within one week. In cases of positive tests for the other 12 hr-HPV types, the cytology evaluation and will follow the Bethesda System Classification Considering that cervical cytology has a very variable sensitivity for the detection of HSIL, in this study protocol, the cytologists will have prior information on HPV tested positive for other 12 hr-HPV types.

The strategy is to increase attention to the smallest morphological details and thus increase the sensitivity of the cytology test. The colposcopic images will be described and classified according to the lastest colposcopic terminology [ 27 ]. The colposcopy unit has two active colposcopists, and they will be informed about the program and to perform colposcopy in cases with positive HPV testwith or without cytology evaluation, a novelty in the routine of these professionals.

The training will be repeated until the colposcopists reach a good or excellent level in agreement tests. The evaluation of the cervical canal will be performed whenever indicated, according to current guidelines, consisting of cervical canal cytological samples or excision procedures [ 28 ]. In the absence of colposcopic changes, no biopsy will be performed. Surgical procedures for excision of the transformation zone EZT will be performed for diagnostic purposes in women with or suspected HSIL.

EZT will be performed using a loop electrosurgical procedure in the same colposcopy unit. In specific clinical situations, the surgical procedure in the cervix will be performed at City Hospital and, exceptionally, by cold knife conization.

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The histopathological evaluation will be performed on cervical tissue samples obtained by biopsies or excision procedures. The pathology laboratory available to serve the routine of the Indaiatuba Health Department will be responsible for this exam. For quality assurance, all biopsies will be tested for p16 immunohistochemistry in an external laboratory.

For discrepant or doubt diagnoses, a senior pathologist from the University of Campinas UNICAMP will review and the final histologic diagnosis will be established by consensus among pathologists and according to the WHO classification [ 29 ]. This study protocol will evaluate one round of HPV five years. Women with positive tests and forwarded colposcopy will return to routine screening 5-year intervals after a colposcopic evaluation is negative and a month follow-up DNA-HPV test is negative.

This process will be repeated yearly until the tests become negative. These data will be included in cost-effectiveness analyses based on appropriate and specific endpoints. Information will be discriminated for every primary health care unit. Thus, we will have the opportunity to monitor and identify areas with adequate population coverage and areas that need further action to achieve adequate coverage. The databases with information generated from this protocol will be revised and analyzed annually and after the study ends. A cost-effectiveness survey is planned for this study, and it will be compared with the screening performed by conventional cervical cytology five years prior.

Such analysis will also consider the diagnostic rates of precursor lesions and cervical cancer corresponding to the HPV test or cervical cytology-based periods. For cost-effectiveness analyses, the Markov model will be built, and the detailed process will be subject to future publication. Cost information regarding the screening process will be collected for the cytology screening and during the implementation of the new program. Qualitative analysis is also foreseen to evaluate the perception of the population and health professionals regarding the modification of the method of cervical cancer screening in the city.

The Ethics Committee also approved the waiver of the Informed Consent Form, considering that this study will analyze data from health system records, without direct contact with patients. This study is considered progress in public health and is aligned with the proposals of screening programs in different places and countries worldwide who started implementation since [ 16303132 ], with a considerable perspective for improving health care offered to the population.

Another important problem foreseen for the near future that can be addressed is about screening in vaccinated women, what is expected to happen fromwhen girls vaccinated in will reach the age to start screening at age There is a tendency for consensus that the DNA-HPV test will be a better way to screen ly vaccinated women [ 3233 ]. The of women never been screened and the real pap screening coverage is unknown at this moment for the majority of Brazilian regions.

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This opportunity will correct a health system distortion that neglects women without periodic preventive tests, and now, starting to use a modern method that requires fewer evaluations in their lives. Health managers agreed with the strategy to have one test available for screening and to simplify the flowchart and decided to eliminate cervical cytology from primary health clinics after the introduction of the DNA-HPV test.

This is the main decision to prevent the possibility of health professionals performing both HPV-DNA tests and cytology for screening purposes, which would be a bias for cost analysis. Now, it is possible to move forward, and the next steps are pretest of the cost-effectiveness model built in a real scenario, analyze the coverage achieved after two years, the prevalence of positive tests by HPV type and age group, outcome according to the program flowchart, and the first interim analyses of the cost-effectiveness of the program. Moving from opportunistic to organized screening has been a challenge, including for the most developed countries.

This fact could be partially attributed to the habit and culture of professionals and women who adopted annual testing with cytological examination as the standard to be followed, despite the recommendations establishing longer intervals.

The introduction of HPV testing as a primary screening method can break with this cultural practice based on the annual routine cytological examination, allowing or facilitating the establishment of a new practice, now a five-year interval based on scientific evidence. Avoiding overtesting due to repetition at shorter intervals saves money and provides resources to invest in increasing population coverage without the need for additional investments beyond those for the active search for women who are not compliant with the cervical cancer screening.

The dataset from this study will be safely stored following the principles of research ethics. Upon completion of the study, data may be made available by the corresponding author upon request with justification. The of this study will be disseminated through publications in journals, presentation of abstracts in scientific congresses and meetings with public health managers. CA Cancer J Clin. Article Google Scholar. Acessed 25 Nov Denny L. Cytological screening for cervical cancer prevention.

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Alternative approaches to cervical cancer screening for developing countries. Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a year cohort analysis.

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