HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study

Abstract

Objective: To determine whether offering self sampling of cervicovaginal material for high risk human papillomavirus (HPV) testing is an effective screening method for women who do not attend regular cervical screening programmes.

Design: Cohort study (the PROHTECT trial). Settings Noord-Holland and Flevoland regions of the Netherlands, December 2006 to December 2007, including 13 laboratories, gynaecologists, and more than 800 general practitioners.

Participants: 28 073 women who had not responded to two invitations to the regular cervical screening programme: 27 792 women were assigned to the self sampling group and invited to submit a self collected cervicovaginal sample for HPV testing; 281 were assigned to the recall control group and received a second re-invitation for conventional cytology.

Intervention: Women with a positive result on the high risk HPV test on their self sample material were referred to their general practitioner. Women with abnormal results on cytology were referred for colposcopy. Women with normal results on cytology were re-evaluated after one year by cytology and high risk HPV testing and referred for colposcopy if either result was positive.

Main outcome measures: Attendance rate in both groups and yield of cervical intraepithelial neoplasia grade II/III or worse (>or=CIN II/>or=CIN III) in self sampling responders.

Results: The compliance rate in the self sampling group was significantly higher than in the control group (crude 26.6% v 16.4%, P<0.001; adjusted 27.5% v 16.6%, P<0.001). The number of detected >or=CIN II and >or=CIN III lesions in self sampling responders was 99 (1.3%) and 76 (1.0%), respectively. Self sampling responders who had not participated in the previous round of screening (43%) had increased relative risks of >or=CIN II (2.04, 95% confidence interval 1.27 to 3.28) and >or=CIN III (2.28, 1.31 to 3.96) compared with self sampling women who had been screened in the previous round (57%).

Conclusions: Offering self sampling by sending a device for collecting cervicovaginal specimens for high risk HPV testing to women who did not attend regular screening is a feasible and effective method of increasing coverage in a screening programme. The response rate and the yield of high grade lesions support implementation of this method for such women. Trial registration ISRCTN45527158.

Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that (1) CJ M, and PJF S have support from Delphi Bioscience B.V. Scherpenzeel, Netherlands, and Qiagen, Gaithersburg, USA, for the submitted work; (2) CJ M, PJ S, and DA H have relationships with Self-screen and CJ M has a relationship with Qiagen that might have an interest in the submitted work in the previous 3 years; (3) their spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and (4) none of the authors have non-financial interests that may be relevant to the submitted work. The sources of funding did not have any influence on the design and the analysis of the results.

Figures

Fig 1 Study design for comparison of compliance rates between recall control group and self sampling group

Fig 2 Study design for evaluation of yield of ≥CIN II in women of self sampling group (BMD=borderline or mild dyskaryosis)