Abstract

BackgroundAttendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees. Acceptability, DNA yield, lavage volumes and choice of hrHPV test can influence effectiveness of the self-sampling procedures and could therefore play a role in recruiting non-attendees. To increase user-friendliness, a frequently used lavage sampler was modified. In this study, we compared this second generation lavage device with the first generation device within similar birth cohorts.MethodsWithin a large self-sampling cohort-study among non-responders of the Dutch cervical screening program, a subset of 2,644 women received a second generation self-sampling lavage device, while 11,977 women, matched for age and ZIP-code, received the first generation model. The second generation device was different in shape, color, lavage volume, and packaging, in comparison to its first generation model. The Cochran’s test was used to compare both devices for hrHPV positivity rate and response rate. To correct for possible heterogeneity between age and ZIP codes in both groups the Breslow-Day test of homogeneity was used. A T-test was utilized to compare DNA yields of the obtained material in both groups.ResultsMedian DNA yields were 90.4 μg/ml (95% CI 83.2-97.5) and 91.1 μg/ml (95% CI 77.8-104.4, p= 0.726) and hrHPV positivity rates were 8.2% and 6.9% (p= 0.419) per sample self-collected by the second - and the first generation of the device (p= 0.726), respectively. In addition, response rates were comparable for the two models (35.4% versus 34.4%, p= 0.654).ConclusionsReplacing the first generation self-sampling device by an ergonomically improved, second generation device resulted in equal DNA yields, comparable hrHPV positivity rates and similar response rates. Therefore, it can be concluded that the clinical performance of the first and second generation models are similar. Moreover, participation of non-attendees in cervical cancer screening is probably not predominantly determined by the type of self-collection device.

Highlights

  • Attendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees

  • In developed countries, incidence rate of and mortality from cervical cancer have decreased since the introduction of cytology based cervical screening [1,2,3,4]

  • Randomized controlled trials have shown that high-risk human papillomavirus testing provides a superior protection against high-grade cervical intraepithelial neoplasia than cytology [5,6,7]

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Summary

Introduction

Attendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees. Incidence rate of and mortality from cervical cancer have decreased since the introduction of cytology based cervical screening [1,2,3,4]. Population based screening could be improved by the introduction of primary hrHPV testing. This will not affect the participation rate of programmed cervical screening, which often is suboptimal. Recent studies have shown that offering selfcollection devices for hrHPV testing on cervico-vaginal specimens to non-attendees may improve compliance to screening [10,11,12,13,14,15,16,17]. Self-sampling has facilitated access to cervical screening for women in developing countries [18,19,20]

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