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Effectiveness of high-risk human papillomavirus testing for cervical cancer screening in China: A multicenter, open-label, randomized clinical trial

JAMA Jan 07, 2021

Zhang J, Zhao Y, Dai Y, et al. - Researchers aimed at evaluating high-risk human papillomavirus (hrHPV) testing as a new screening modality for China’s national cervical cancer screening program. In this population-based, multicenter, open-label, randomized clinical trial that took place across 20 primary health care centers in urban and rural areas across China, the included 60,732 women. They randomly assigned women to cytology, hrHPV testing, or visual inspection with acetic acid and Lugol iodine (VIA/VILI) (rural only) at baseline. Randomization of women who tested positive for hrHPV into cytology-triage, VIA/VILI-triage (rural only), or direct colposcopy arms was done. Relative to cytology or visual inspection with acetic acid and Lugol iodine as primary screening at baseline, hrHPV testing resulted in a 2.0-fold to 2.7-fold yield for cervical intraepithelial neoplasia grade 2 or worse and grade 3 or worse. Under routine conditions in primary healthcare settings in rural areas across China, hrHPV testing was correlated with a significantly reduced risk of cervical intraepithelial neoplasia grade 2 or worse and grade 3 or worse for baseline-negative women. These findings support incorporation of hrHPV testing (polymerase chain reaction–based testing for urban areas, hybrid capture–based testing for rural areas) as a primary screening method into China’s current national screening program.

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