Cervical cancer screening program based on primary DNA-HPV testing in a Brazilian city: a cost-effectiveness study protocol

Abstract

Background 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. 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. Methods The 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). Discussion 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. 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.

Is the HPV-test more cost-effective than cytology in cervical cancer screening? An economic analysis from a middle-income country

“…In 2017 Indaiatuba adopted the hrHPV test to replace cytology in cervical cancer screening. A detailed description of the program was previously published by Teixeira and colleagues [18]. In summary, the hrHPV test chosen provides individual results on the highest risk [18].…”

“…A detailed description of the program was previously published by Teixeira and colleagues [18]. In summary, the hrHPV test chosen provides individual results on the highest risk [18]. In Brazil, the target women for cervical cancer screening are those aged 25 to 64 [20].…”

Elimination of cervical cancer in low‐ and middle‐income countries: Inequality of access and fragile healthcare systems

“…The new screening program aims to reach 80% coverage after the first round in the target population (approximately 28 000 women). A cost‐effectiveness study comparing previous cytology‐based screening will be continuous, with results planned after 5 years of implementation (first round) 38 …”

“…Boys aged 11–13 years were included in 2017. Although coverage was high in the first year of the national program, it is currently around 40% 38 . In Indaiatuba, 83% of girls and boys aged 9–10 years are enrolled in public schools.…”

Human Papillomavirus Genotyping as a Tool for Cervical Cancer Prevention: From Commercially Available Human Papillomavirus DNA Test to Next-Generation Sequencing

“…Conventional cytology has less of an automated management, requiring a trained professional to analyze samples microscopy, and therefore, classify the lesion of the squamous epithelium according to the smear on a slide. HPV testing has been gaining more space, because it’s easier handling in diagnosis with automation methods and precision in the identification of oncogenic types of HPVs in possible lesions, leading to a faster and more effective process [ 54 ].…”