Background/Objectives: Self-sampling is recognized as a viable alternative to clinician-sampling for HPV primary screening. This study aimed to assess, within an Italian organized cervical cancer screening program, the acceptance and ease of use of self-sampling and the adherence to follow-up. The prevalences of HPV infection, cervical dysplasia, and cancer were contextually evaluated.Methods: Electronic records of 19,327 women, 30–64 years-old, residing within the Bologna Local Health Authority territory, who were offered self-sampling as an alternative to clinician-sampling, were retrospectively reviewed. They had never or irregularly attended and were overdue for a screening invitation due to the COVID-19 pandemic. An opt-in approach was adopted, involving local pharmacies for kit delivery and sample collection. Initially, HPV-positive results led to direct referral to colposcopy; later, cytological triage on clinician-samples was provided.Results: Self-sampling reached over twice as many women (11.5%) compared to historical clinician-sampling alone (<5%), showing high acceptance. Additionally, a high screening completion level was observed, with 79.5% of self-samples returned to pharmacies. A low percentage of self-samples resulted in inadequate results (1.1%), suggesting the method’s ease of use. HPV-positivity was 13.1%, higher than the 9.9% recorded in the ordinary screening population in 2019 (p< 0.001), the last year before the pandemic. Compliance to both immediate colposcopy and cytology triage exceeded 90% (p= 0.675). The rate of cervical adenocarcinoma was twice as high as in the routinely screened population in 2019 (0.9‰ versus 0.4‰). Finally, 6% of women opted for clinician appointments.Conclusions: Self-sampling proved to be an easy-to-use and effective tool for reaching non-attenders, who are at high risk of cancer. Cytology triage on clinician-samples did not negatively impact follow-up adherence. It seems appropriate to maintain a clinician-collection option even among non-attenders.
背景/目的：自我采样被认为是HPV初筛中临床医生采样的可行替代方案。本研究旨在评估意大利一项有组织的宫颈癌筛查项目中，自我采样的接受度、易用性以及后续随访依从性，并同步评估HPV感染、宫颈发育不良及癌症的检出率。 方法：本研究回顾性分析了博洛尼亚地方卫生局辖区内19,327名30-64岁女性的电子记录。这些女性既往从未或未规律参与筛查，且因COVID-19大流行而错过常规筛查邀请。研究采用自愿参与模式，通过当地药房发放和回收采样试剂盒。初期，HPV阳性结果直接转诊阴道镜检查；后期则对临床医生采集的样本进行细胞学分流。 结果：自我采样覆盖的女性比例（11.5%）是历史临床医生单独采样（<5%）的两倍以上，显示出较高的接受度。此外，筛查完成度较高，79.5%的自我采样样本被送回药房。样本不合格率较低（1.1%），表明该方法易于操作。HPV阳性率为13.1%，高于大流行前最后一年（2019年）常规筛查人群的9.9%（p<0.001）。对直接阴道镜检查和细胞学分流的依从性均超过90%（p=0.675）。宫颈腺癌检出率为0.9‰，是2019年常规筛查人群（0.4‰）的两倍。最后，有6%的女性选择了临床医生采样。 结论：自我采样被证明是一种易于使用且有效的工具，可用于覆盖癌症高风险的非筛查参与人群。对临床医生样本进行细胞学分流并未对随访依从性产生负面影响。即使在非筛查参与人群中，保留临床医生采样选项似乎是合适的。
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