Objective:We aimed to evaluate the effectiveness of different triage strategies for high-risk human papillomavirus(hrHPV)-positive women in primary healthcare settings in China.Methods:This study was undertaken in 11 rural and 9 urban sites.Women aged 35-64 years old were enrolled.HrHPV-positive women were randomly allocated to liquid-based cytology(LBC),visual inspection with acetic acid and Lugol's iodine(VIA/VILI)(rural only)triage,or directly referred to colposcopy(direct COLP).At 24 months,hrHPV testing,LBC and VIA/VILI were conducted for combined screening.Results:In rural sites,1,949 hrHPV-positive women were analyzed.A total of 852,218 and 480 women were randomly assigned to direct COLP,LBC and VIA/VILI.At baseline,colposcopy referral rates of LBC or VIA/VILI triage could be reduced by 70％-80％.LBC(n=3 and n=7)or VIA/VILI(n=8 and n=26)could significantly decrease the number of colposcopies needed to detect one cervical intraepithelial neoplasia(CIN)2 or worse and CIN3+compared with direct COLP(n=14 and n=23).For the 24-month cumulative detection rate of CIN2+,VIA/VILI triage was 0.50-fold compared with LBC triage and 0.46-fold with the direct COLP.When stratified by age,baseline LBC triage+performed best(P＜0.001),peaking among women aged 35-44 years(Ptrend=0.002).In urban sites,1,728 women were hrHPV genotyping test positive.A total of 408,571 and 568 women were randomly assigned to direct COLP for HPV16/18+,direct COLP for other hrHPV subtypes+,and LBC triage for other hrHPV subtypes+.LBC(n=12 and n=31)significantly decreased the number of colposcopies needed to detect one CIN2+and CIN3+compared with direct COLP(n=14 and n=44).HPV16/18+increased the 24-month cumulative detection rate of CIN2+(17.89％,P＜0.001).Conclusions:LBC triage for hrHPV-positive women in rural settings and direct COLP for HPV16/18+women and LBC triage for other hrHPV subtype+women in urban settings might be feasible strategies.

Le Dang;Linghua Kong;Yuqian Zhao;Yi Dai;Li Ma;Lihui Wei;Shulan Zhang;Jihong Liu;Mingrong Xi;Long Chen;Xianzhi Duan;Qing Xiao;Guzhalinuer Abulizi;Guonan Zhang;Ying Hong;Qi Zhou;Xing Xie;Li Li;Mayinuer Niyazi;Zhifen Zhang;Jiyu Tuo;Yiling Ding;Youlin Qiao;Jinghe Lang

Department of Gynecology and Obstetrics,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences/Peking Union Medical College,Beijing 100730,China;National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Center for Cancer Prevention Research,Sichuan Cancer Hospital and Institute,Sichuan Cancer Center,School of Medicine,University of Electronic Science and Technology of China,Chengdu 610041,China;Department of Epidemiology,Dalian Medical University,Dalian 116044,China;Department Obstetrics and Gynecology,Peking University People's Hospital,Beijing 100044,China;Department of Obstetrics and Gynecology,Shengjing Hospital Affiliated to China Medical University,Shenyang 110004,China;Department of Gynecology and Obstetrics,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;Department of Gynecology and Obstetrics,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Department of Gynecology and Obstetrics,Zhejiang Xiaoshan Hospital Affiliated to Hangzhou Normal University,Chinese Academy of Medical Sciences/Zhejiang Xiaoshan Hospital Affiliated to Hangzhou Normal University,Hangzhou 310000,China;Department of Obstetrics and Gynecology,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China;Department of Gynecology and Obstetrics,the Eight Affiliated Hospital Sun Yat-sen University,Shenzhen 518000,China;125th Department of Gynecology,the Affiliated Cancer Hospital of Xinjiang Medical University,Urumqi 830011,China;Department of Gynecologic Oncology,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,School of Medicine,University of Electronic Science and Technology of China,Chengdu 610041,China;Department of Gynecology and Obstetrics,Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;Department of Gynecological Oncology,Chongqing University Cancer Hospital/Chongqing Cancer Hospital,Chongqing 400030,China;Department of Gynecologic Oncology,Women's Hospital,School of Medicine Zhejiang University,Hangzhou 310006,China;Department of Gynecology and Obstetrics,Tumor Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China;Department of Gynecology,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830000,China;Department of Gynecology,Hangzhou Women's Hospital,Hangzhou 310016,China;Department of Gynecology and Obstetrics,Hubei Cancer Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430079,China;Department of Gynecology and Obstetrics,the Second Xiangya Hospital of Central South University,Changsha 410011,China;School of Population Medicine and Public Health,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100005,China

中国癌症研究（英文版）

[1]Le Dang;Linghua Kong;Yuqian Zhao;Yi Dai;Li Ma;Lihui Wei;Shulan Zhang;Jihong Liu;Mingrong Xi;Long Chen;Xianzhi Duan;Qing Xiao;Guzhalinuer Abulizi;Guonan Zhang;Ying Hong;Qi Zhou;Xing Xie;Li Li;Mayinuer Niyazi;Zhifen Zhang;Jiyu Tuo;Yiling Ding;Youlin Qiao;Jinghe Lang-.Evaluation of triage strategies for high-risk human papillomavirus-positive women in cervical cancer screening:A multicenter randomized controlled trial in different resource settings in China)[J].中国癌症研究（英文版）,2022(05):496-509

HrHPV,Lugol,colposcopy,COLP,colposcopies,CIN3+compared,triage+performed,18+,subtypes+,CIN2+and,18+increased,18+women,subtype+women

Evaluation,strategies,high,risk,human,papillomavirus,positive,cervical,cancer,screening,multicenter,randomized,controlled,trial,different,resource,settings,China,Objective,We,aimed,evaluate,effectiveness,hrHPV,primary,healthcare,Methods,This,study,was,undertaken,rural,urban,sites,Women,aged,years,were,enrolled,randomly,allocated,liquid,cytology,LBC,visual,inspection,acetic,acid,iodine,VIA,VILI,only,directly,referred,At,months,testing,conducted,combined,Results,In,analyzed,total,assigned,baseline,referral,rates,could,reduced,by,significantly,number,needed,one,intraepithelial,neoplasia,worse,For,cumulative,detection,fold,When,stratified,best,peaking,among,Ptrend,genotyping,HPV16,other,decreased,Conclusions,might,feasible

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