Abstract
BackgroundThe 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. The increased sensitivity of DNA-HPV testing compared to cervical cytology favors DNA-HPV testing as a primary screening test. Cervical cancer screening in Brazil is opportunistic, and this cancer remains a considerable health problem with a high proportion of diagnoses in advanced stages. This paper aims to describe the design and implementation of the Cervical Cancer Screening Program with primary DNA-HPV testing (CCSP-HPV) planned for Indaiatuba City (SP), Brazil; the strategies to achieve higher population coverage; and a study protocol for cost-effectiveness analyses.MethodsThe CCSP-HPV was designed based on successful guidelines that replaced cervical cytology-based screening by the DNA-HPV test performed at 5-year intervals. The screening will be performed for the female population aged 25-64 years cared for by the public health system and aim to reach 80% coverage after completing the first round. The chosen DNA-HPV test detects 14 hr-HPV types and genotypes HPV-16 and 18. All women with a negative test will be reassessed after five years. Women showing a positive test for HPV-16 and/or 18 will be referred for colposcopy. 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. 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 (2011–2016).DiscussionThe 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. Achieving at least 80% coverage will have the possibility to change this scenario. 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.
Highlights
The causal relationship between high-risk HPV infection and precancerous lesions or cervical cancer has led to the development of strategies to increase screening performance and prevent this cancer
This paper aims to describe the implementation of the Cervical Cancer Screening Program with Primary DNA-HPV testing (CCSP-HPV), the strategies designed to reach higher population coverage, and a study protocol for the cost-effectiveness analyses
The main point is to make it possible to achieve an adequate organization status of cervical cancer screening in the public health care scenario and reach more than 80% coverage over the target population, women 25-64 years old. Another important problem foreseen for the near future that can be addressed is about screening in vaccinated women, what is expected to happen from 2025, when girls vaccinated in 2014 will reach the age to start screening at age 25
Summary
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. 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 [3, 4]. These factors promote the search for alternative strategies, such as HPV molecular testing
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