Trial reportArchives of gynecology and obstetrics2026
Comparison of three different hpv self-sampling tools - a subanalysis of the prospective, randomized hannover self-collection study.
Trial report in Archives of gynecology and obstetrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
Funding
Abstract
objectiveCervical cancer and its precursor lesions are treatable if detected early; however, screening participation for high-risk human papillomavirus infections (hr-HPV) remains low. In 2021, Germany recorded 4,544 new cervical cancer cases and 2,071 related deaths. The HaSCo study evaluates the feasibility of HPV self-testing to improve screening participation. This sub-study evaluates performance and acceptability of three self-testing tools.
methodsThis prospective, randomized sub-study examined Evalyn-Brush, FLOQSwabs, and first-void urine Colli-Pee among women aged 30-65 in Hannover, Germany. Addresses from the residents´ registration office were randomized into seven age groups and an 80/20 city-region distribution. A total of 19,995 women were assigned to opt-in (request a self-test) or opt-out (receive a test directly). Participation was requested from women without regular screening in the past two years.
results1,860 samples were returned (9.3%). Colli-Pee (10.4%) and FLOQSwabs (10.1%) had similar return rates, while Evalyn showed significantly lower rates (7.4%). Screening frequency didn´t significantly affect return rates (p = 0.1825), although FLOQSwabs showed higher return rates among underscreened women. Invalid sample rates were low, highest for FLOQSwabs (1.67%). A total of 145 samples tested positive for hr-HPV (7.9%). Evalyn collected highest DNA content (p < 0.0001). Colli-Pee was most preferred, and 66.7% of participants favored self-testing.
conclusionHPV self-tests were highly accepted and effective for collecting sufficient DNA material. Direct provision of user-friendly self-tests may support screening participation, particularly among underscreened women. All three devices performed strongly and appear suitable for integration into cervical cancer screening programs.
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