Analysis of the implementation model of the organized screening strategy using the pCR DNA molecular test as the primary test for detecting high-risk human papillomavirus (HPV) for the control and elimination of cervical cancer: Pilot project for nationalization in Brazil.

Abstract

e13536 Background: Cervical cancer (CC) is a disease with high incidence and disproportionate mortality in low-income and socially vulnerable regions. In 2024, the Brazilian Ministry of Health decided to incorporate molecular tests for the detection of oncogenic HPV DNA PCR as a public policy, as a primary screening method, within an organized screening process and in line with the CC elimination strategy. Pilot projects are being initiated in the pre-implementation phase on a larger scale to analyze partial results of the the organized population screening program for women at risk of cervical cancer in Pernambuco, Brazil. Methods: analytical study from September 2023 - December 2024 of the files of the multiple national public registries . The primary screening test was a biological sampling collection method for high-risk HPV testing, HPV 16 and 18 tested separately and high-risk (AR) other HPV (31, 33, 35, 39, 45, 51, 56, 58, 59, 66 and 68). Liquid-based cytology analysis was performed on the same material collected and, if altered, the patient was referred for colposcopy. The Bethesda System was used for cytological diagnosis. Patients with identified high-risk lesions were referred for treatment according to the guidelines and, together with the group and the professionals involved, an analysis matrix of the essential criteria for an organized screening program (IArC/ WHO) was carried out in accordance with the goals of the WHO for the elimination of CC and identified opportunities for improvements for a new stage of implementation. Results: Until January 2025, 21,273 samples collected in 23 municipalities were processed, 68.6% in urban areas, (12.0%) 2,510 women have oncogenic HPV: 398 HPV 16 (16%), HPV 18 150 (6%) and 1,962 HPV AR OTHERS (9.4%) and 0.3% inconclusive. 316 (1.5)%.The time for the HPV test result was approximately 14 days. were collected outside the age range, the majority < 25 years old, and among those who tested positive the majority were HPV AR others (94%). The majority of women were black/brown and 15% identified as yellow. The target percentage of collection for the first round varied between municipalities 138% to 14.6%. a prototype of a unified information system was developed for the journey. Conclusions: The collection and implementation of HPV testing is feasible and has a high level of acceptance by users and professionals. However, it is necessary to identify inequities in order to coordinate actions according to the criteria. Clear agreements and explicit responsibilities are needed with a high level of intersectoral cooperation between the national, regional and local levels.