Pedersen Birgitte Tønnes, Sonne Si Brask, Pedersen Helle, Andreasen Emilie Korsgaard, Serizawa Reza, Ejegod Ditte Møller, Bonde Jesper
Department of Pathology, Copenhagen University Hospital AHH-Hvidovre, Hvidovre, Denmark.
Int J Cancer. 2025 Apr 15;156(8):1594-1605. doi: 10.1002/ijc.35263. Epub 2024 Nov 23.
Broad accessibility to cervical cancer screening and high participation rate is essential to reduce cervical cancer incidence. HPV self-sampling is an alternative to clinician collected cervical samples to increase accessibility and screening coverage. To inform on deployment strategies of HPV self-sampling, this large-scale, randomized, pragmatic study compared two invitation modalities; direct-mail and opt-in. The study included screening non-attenders from the Capital Region of Denmark randomly allocated (1:4) to a direct-mail or opt-in invitation for cervical screening by HPV self-sampling. Primary endpoint was screening participation; secondary endpoints were HPV prevalence and histology outcome. Adherence to follow-up and cost were also evaluated. After exclusion of hysterectomized/non-accessible women, 49,393 women were invited: 9639 by direct-mail, and 39,754 by the opt-in offer. A direct-mail invitation for HPV self-sampling yielded a significant higher participation than an opt-in invitation. HPV self-sample participation for direct-mail was 25.2% (n = 2426), opt-in participation was 20.2% (n = 8047), adjusted OR = 1.27, 95% CI 1.20-1.34. Participation increased with age (p < .0001) for both strategies and decreased with screening history of non-attendance (p < .0001). Interaction between invitation strategy and age/screening history was found; more women below 50 years of age participated by direct-mail compared to opt-in (p < .0001) and higher participation by direct-mail group was found in women with a short history of non-attendance (p < .0001). Participation of long-term unscreened women was similar between arms. The relative cost was ≈14 HPV self-sample kits distributed per additional participant by direct-mail over opt-in. HPV prevalence, adherence to follow-up, and detection of high-grade cervical intraepithelial neoplasia was similar between invitation strategies.
广泛普及宫颈癌筛查并提高参与率对于降低宫颈癌发病率至关重要。人乳头瘤病毒（HPV）自我采样是一种替代临床医生采集宫颈样本的方法，可提高筛查的可及性和覆盖范围。为了为HPV自我采样的推广策略提供信息，这项大规模、随机、实用性研究比较了两种邀请方式：直接邮寄和选择加入。该研究纳入了丹麦首都地区未参加筛查的人群，将其随机分配（1:4）至直接邮寄或选择加入邀请组，通过HPV自我采样进行宫颈癌筛查。主要终点是筛查参与率；次要终点是HPV感染率和组织学结果。还评估了随访依从性和成本。在排除子宫切除/无法联系的女性后，共邀请了49393名女性：直接邮寄邀请9639名，选择加入邀请39754名。直接邮寄HPV自我采样邀请的参与率显著高于选择加入邀请。直接邮寄组的HPV自我采样参与率为25.2%（n = 2426），选择加入组为20.2%（n = 8047），调整后的比值比为1.27，95%置信区间为1.20 - 1.34。两种策略的参与率均随年龄增加而升高（p <.0001），随未参加筛查的历史而降低（p <.0001）。发现邀请策略与年龄/筛查历史之间存在交互作用；与选择加入相比，直接邮寄方式使更多50岁以下女性参与（p <.0001），且在未参加筛查历史较短的女性中，直接邮寄组的参与率更高（p <.0001）。长期未筛查女性在两组中的参与率相似。直接邮寄方式每增加一名参与者的相对成本比选择加入方式约多分发14份HPV自我采样试剂盒。两种邀请策略在HPV感染率、随访依从性以及高级别宫颈上皮内瘤变的检出率方面相似。
