HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study
Open accessAbstract
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.
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Five studies provided response rates in both trial arms stratified by categories defined on the screening history status.
“We found five studies that provided response rates in both trial arms stratified by categories defined on the screening history status.”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [103]
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- Authors
- Gok, M., Heideman, D. A. M., van Kemenade, F. J., Berkhof, J., Rozendaal, L., Spruyt, J. W. M., Voorhorst, F., Belien, J. A. M., Babovic, M., Snijders, P. J. F., & Meijer, C. J. L. M.
- Affiliations
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Corresponding author
- Meijer, C. J L M
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2010-03-11
- Volume
- 340
- Issue
- mar11 1
- Pages
- c1040-c1040
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC2837143
- OpenAlex
- W2050815280
- Cited by
- 293
- References
- 0
- Citations by year
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- FWCI
- 18.91
- Type
- journal article
- Language
- en
- Update notices
- correction (2016-05-18)
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Cancer Center Amsterdam
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- self-sampling, cervicovaginal lavage, cervical cancer screening, cervical intraepithelial neoplasia, screening adherence, colposcopy referral
- MeSH terms
- Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Cervix Uteri, Colposcopy, Female, Humans, Therapeutic Irrigation, Mass Screening, Middle Aged, Netherlands, Patient Compliance, Self Care, Specimen Handling, Vagina, Vaginal Smears, Papillomavirus Infections, Early Detection of Cancer
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