Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial

Abstract

Background: Cervical cancer screening participation remains insufficient in most countries. Our aim was to evaluate whether offering a HPV self-sampling kit, either mailed directly to the woman's home or using timely opt-in procedures for ordering the kit, increased screening participation compared with a standard second reminder.

Methods: In this randomized, controlled effectiveness trial, 9791 Danish women aged 30-64 who were due to receive the second reminder were equally randomized to either: 1) direct mailing of a second reminder and a self-sampling kit (directly mailed group); 2) mailing of a second reminder that offered a self-sampling kit to be ordered by e-mail, text message, phone, or webpage (opt-in group); or 3) mailing of a second reminder to attend regular cytology screening (control group). In an intention-to-treat analysis, we estimated the participation rate at 180 days post intervention, by returning a self-sample or attending regular cytology screening. We calculated the proportion of women with a positive HPV self-sample who attended for cervical cytology triage at the general practitioner within 90 days.

Results: Participation was significantly higher in the directly mailed group (38.0%) and in the opt-in group (30.9%) than in the control group (25.2%) (participation difference (PD): 12.8%, 95% CI: 10.6-15.0% and PD: 5.7%, 95% CI: 3.5-7.9%, respectively). Within 90 days, 107 women (90.7%, 95% CI: 83.9-95.3%) with a HPV-positive self-sample attended follow-up.

Conclusions: Offering the opportunity of HPV self-sampling as an alternative to regular cytology screening increased participation; the direct mailing strategy was the most effective invitation strategy. A high compliance with follow-up was seen.

Trial registration: Current Controlled Trials NCT02680262 . Registered 10 February 2016.

Keywords: Cancer prevention; Cervical cancer screening; Human papillomavirus testing; Screening participation; Self-sampling.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Danish Data Protection Agency (j.no: 1–16–02-495-15) and by the Danish Health Authorities (j.no: 3–3013-1407/1). Furthermore, the study achieved clearance at the Central Denmark Region Committees on Health Research Ethics (j.no: 1–10–72-259-15). The included women were informed that if they returned their self-sample they thereby expressed their consent to participate in the study.

Consent for publication

Not applicable.

Competing interests

Axlab, the Danish manufacturer of Evalyn® Brush, and Roche, the manufacturer of the Cobas® 4800 HPV DNA assay, provided self-sampling devices and test kits for the study. According to the contract between the manufacturers and the Department of Public Health Programmes, Randers Regional Hospital, Axlab and Roche had no influence on the scientific process and no editorial rights pertaining to this manuscript. The authors retained the right to submit the manuscript. None of the authors were compensated for their work on this study, have any shares in the manufacturers’ companies, or received bonuses from any of the manufacturers. All authors declare no conflicts of interest.

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Figures

Fig. 1

Flow chart of the study design. Abbreviations: HPV self-sampling: HPV SS. GP: General Practitioner.*) Also had the possibility of attending a GP for regular cytology screening