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


METHODS
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.


METHODS
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.


METHODS
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.


METHODS
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.
Department of Pathology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, Netherlands.
Murat
M
Gök
Daniëlle A M
DA
Heideman
Folkert J
FJ
van Kemenade
Johannes
J
Berkhof
Lawrence
L
Rozendaal
Johan W M
JW
Spruyt
Feja
F
Voorhorst
Jeroen A M
JA
Beliën
Milena
M
Babovic
Peter J F
PJ
Snijders
Chris J L M
CJ
Meijer
D000328:Adult; D002584:Cervix Uteri / Q000821:virology; D003127:Colposcopy; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009426:Netherlands; D030361:Papillomavirus Infections / Q000175:diagnosis*; D010349:Patient Compliance; D012648:Self Care; D013048:Specimen Handling; D007507:Therapeutic Irrigation; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology; D014621:Vagina / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control* / Q000821:virology