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澳大利亚 HPV 自我采样及两轮宫颈癌筛查随访 - iPap 试验。

HPV self-sampling and follow-up over two rounds of cervical screening in Australia - the iPap trial.

机构信息

formerly VCS Population Health, VCS Foundation, East Melbourne, Victoria, Australia.

Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, 50066University of Melbourne, Melbourne, Victoria, Australia.

出版信息

J Med Screen. 2022 Sep;29(3):185-193. doi: 10.1177/09691413221080635. Epub 2022 Mar 22.

DOI:10.1177/09691413221080635
PMID:35313763
Abstract

OBJECTIVES

Previously, based on 6 months of follow-up, we showed that HPV self-sampling improved participation in cervical screening compared to a reminder letter for Pap testing for never- and under-screened women. Here, we report follow-up and related screening outcomes for women who participated in the initial self-sampling over two screening rounds.

SETTING

The randomised controlled trial was conducted in Australia.

METHODS

Never- and under-screened women were randomly allocated to the HPV self-sampling or the reminder for Pap test arm and followed at 6 and 36 months since the kits were first mailed.

RESULTS

The first round of HPV self-sampling kits were mailed from May-July 2014 to 12 572 women. After 36 months, 19% of never-screened and 9% of under-screened women returned a kit for HPV testing; 2.7% were HPV 16/18 and 5.8% non-16/18 HPV positive. Compliance with first round follow-up was 84% (95% CI: 77.1-89.5%). Non-compliant and cytology triage negative women were mailed another kit at 12 months. Compliance at 12-month follow-up was 59.3% (49.4 to 68.6%). Of 37 women with a 12-month repeat HPV, 70% were positive. Of women who tested negative for HPV in the first round (n = 1573), 25% attended regular screening in the next round and none had CIN2 + detected. The overall prevalence of CIN2 + was 8.5 per 1000 screened (4.8 to 13.9 per 1000).

CONCLUSION

While self-sampling can successfully engage women, compliance with repeat testing may require monitoring. The clinician-supported self-collection pathway now in use in Australia will likely improve women's engagement with follow-up.

摘要

目的

此前,我们基于 6 个月的随访结果表明,与巴氏涂片检测的提醒信相比,HPV 自我采样提高了从未接受过或未接受过筛查的女性参与宫颈癌筛查的比例。在此,我们报告了最初参与自我采样的女性在两个筛查轮次中的随访结果和相关筛查结果。

背景

该随机对照试验在澳大利亚进行。

方法

从未接受过或未接受过筛查的女性被随机分配到 HPV 自我采样组或巴氏涂片检测提醒组,并在试剂盒首次邮寄后的 6 个月和 36 个月进行随访。

结果

2014 年 5 月至 7 月,第一轮 HPV 自我采样试剂盒邮寄给了 12572 名女性。36 个月后,19%的从未筛查过的女性和 9%的筛查不足的女性返回了 HPV 检测试剂盒;2.7%为 HPV16/18 阳性,5.8%为非 16/18 HPV 阳性。第一轮随访的依从率为 84%(95%CI:77.1-89.5%)。不依从和细胞学分流阴性的女性在 12 个月时再次收到试剂盒。12 个月时的依从率为 59.3%(49.4 至 68.6%)。在 37 名 12 个月重复 HPV 检测呈阳性的女性中,有 70%的女性呈阳性。在第一轮 HPV 检测呈阴性的 1573 名女性中,有 25%在接下来的一轮中定期接受筛查,且无一例检测出 CIN2+。总的 CIN2+患病率为每 1000 人筛查 8.5 例(每 1000 人筛查 4.8 至 13.9 例)。

结论

虽然自我采样可以成功吸引女性参与,但重复检测的依从性可能需要监测。澳大利亚目前使用的由临床医生支持的自我采集途径可能会提高女性对随访的参与度。

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