Background The efficacy of cervical cancer screening programs is dependent on the participation rate. To increase participation among women not attending cervical cancer screening, self-collected samples for detection of high-risk human papillomavirus (hr-HPV) may be an option. The aims of this study were: to investigate the response rate to sending a self-collected vaginal sample for hr-HPV mRNA detection to long-term non-attendees; the compliance with follow-up among women positive for HPV in the self-sample; the prevalence of cervical dysplasia (high grade squamous intraepithelial lesion (HSIL), atypical squamous cells that cannot exclude HSIL (ASC-H) or adenocarcinoma in situ (AIS)) or cancer among the responders; as well as to explore reasons for not returning a self-sample. Methods A vaginal self-sampling kit was sent to 6023 women aged 30–70 years who had not provided a cervical screening sample for ≥7 years in the Region of Skåne, Sweden in November and December 2017. The self-sample was analyzed by Aptima HPV mRNA assay (Hologic). All vaginal self-samples returned no later than May 31, 2018 were included in the study. Follow-up of the results was registered until January 31, 2019 with a follow-up time varying between eight to 14 months. Women positive for hr-HPV mRNA were invited for a follow-up examination. This examination consisted of a cervical sample for cytological analysis and renewed Aptima HPV mRNA testing. Two hundred thirty-five women who had not returned the self-sample were randomly selected for telephone interviews, in order to explore their reasons. Results The response rate for the self-collected vaginal hr-HPV sample was 13.2% [(797/6023), 95% CI 12.4–14.1%] and 9.9% [(79/796), 95% CI 7.9–12.2%] were positive for hr-HPV mRNA. The prevalence of severe dysplasia or cancer in the whole group of responders was 1.3% [(10/796), 95% CI 0.6–2.3%], with a cervical cancer prevalence of 0.4% [(3/796), 95% CI 0.1–1.1%]. Only 27 women participated in the telephone interviews, no particular reason for not returning self-samples was observed. Conclusions Self-collected vaginal hr-HPV samples increased participation in the cervical cancer screening among long-term non-attendees. The prevalence of cervical cancer was almost seven times higher for long-term non-attendees than in the organized screening population.

中文翻译：

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通过阴道自收集样本进行hr-HPV mRNA检测对长期筛查未参加者的宫颈癌预防

背景 宫颈癌筛查项目的效果取决于参与率。为了提高未参加宫颈癌筛查的女性的参与度，可以选择自行收集样本以检测高危人乳头瘤病毒 (hr-HPV)。本研究的目的是：调查向长期未参加者发送自我收集的阴道样本进行 hr-HPV mRNA 检测的反应率；自我样本中 HPV 阳性女性的随访依从性；宫颈发育不良（高度鳞状上皮内病变 (HSIL)、不能排除 HSIL (ASC-H) 或原位腺癌 (AIS) 的非典型鳞状细胞）或癌症的患病率；以及探索不返回自我样本的原因。方法 2017 年 11 月和 2017 年 12 月，向瑞典斯科讷地区 6023 名年龄在 30-70 岁且超过 7 年未提供宫颈筛查样本的女性发送阴道自采样试剂盒。使用 Aptima 分析自检样本。 HPV mRNA测定（Hologic）。不迟于 2018 年 5 月 31 日返回的所有阴道自我样本都包括在研究中。结果的随访登记至 2019 年 1 月 31 日，随访时间为 8 至 14 个月。邀请hr-HPV mRNA阳性的女性进行随访检查。该检查包括用于细胞学分析的宫颈样本和更新的 Aptima HPV mRNA 检测。随机抽取 235 名未返回自我样本的女性进行电话访谈，以探究她们的原因。结果 自行采集的阴道 hr-HPV 样本的反应率为 13.2% [(797/6023), 95% CI 12.4–14.1%] 和 9.9% [(79/796), 95% CI 7.9–12.2%] hr-HPV mRNA呈阳性。整个反应组中严重发育不良或癌症的患病率为 1.3% [(10/796), 95% CI 0.6–2.3%]，宫颈癌患病率为 0.4% [(3/796), 95% CI 0.1–1.1%]。只有 27 名女性参加了电话采访，没有发现没有返回自我样本的特殊原因。结论 自行收集的阴道 hr-HPV 样本增加了长期未参加者对宫颈癌筛查的参与。长期未参加者的宫颈癌患病率几乎是有组织筛查人群的 7 倍。9–12.2%] hr-HPV mRNA 呈阳性。整个反应组中严重发育不良或癌症的患病率为 1.3% [(10/796), 95% CI 0.6–2.3%]，宫颈癌患病率为 0.4% [(3/796), 95% CI 0.1–1.1%]。只有 27 名女性参加了电话采访，没有发现没有返回自我样本的特殊原因。结论 自行收集的阴道 hr-HPV 样本增加了长期未参加者对宫颈癌筛查的参与。长期未参加者的宫颈癌患病率几乎是有组织筛查人群的 7 倍。9–12.2%] hr-HPV mRNA 呈阳性。整个反应组中严重发育不良或癌症的患病率为 1.3% [(10/796), 95% CI 0.6–2.3%]，宫颈癌患病率为 0.4% [(3/796), 95% CI 0.1–1.1%]。只有 27 名女性参加了电话采访，没有发现没有返回自我样本的特殊原因。结论 自行收集的阴道 hr-HPV 样本增加了长期未参加者对宫颈癌筛查的参与。长期未参加者的宫颈癌患病率几乎是有组织筛查人群的 7 倍。只有 27 名女性参加了电话采访，没有发现没有返回自我样本的特殊原因。结论 自行收集的阴道 hr-HPV 样本增加了长期未参加者对宫颈癌筛查的参与。长期未参加者的宫颈癌患病率几乎是有组织筛查人群的 7 倍。只有 27 名女性参加了电话采访，没有发现没有返回自我样本的特殊原因。结论 自行收集的阴道 hr-HPV 样本增加了长期未参加者对宫颈癌筛查的参与。长期未参加者的宫颈癌患病率几乎是有组织筛查人群的 7 倍。