Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial

K Haguenoer, S Sengchanh, C Gaudy-Graffin, J Boyard, R Fontenay, H Marret, A Goudeau, N Pigneaux de Laroche, E Rusch, B Giraudeau, K Haguenoer, S Sengchanh, C Gaudy-Graffin, J Boyard, R Fontenay, H Marret, A Goudeau, N Pigneaux de Laroche, E Rusch, B Giraudeau

Abstract

Background: Cervical cancer screening coverage remains insufficient in most countries. Our objective was to assess whether in-home vaginal self-sampling with a dry swab for high-risk human papillomavirus (HR-HPV) testing is effective and cost-effective in increasing participation in cervical cancer screening.

Methods: In March 2012, 6000 unscreened women aged 30-65 years, living in a French region covered by a screening programme, who had not responded to an initial invitation to have a Pap smear were equally randomised to three groups: 'no intervention'; 'recall', women received a letter to have a Pap smear; and 'self-sampling', women received a self-sampling kit to return to a centralised virology laboratory for PCR-based HPV testing.

Results: Participation was higher in the 'self-sampling' than in the 'no intervention' group (22.5% vs 9.9%, P<0.0001; OR 2.64) and 'recall' group (11.7%, P<0.0001; OR 2.20). In the 'self-sampling' group, 320 used the self-sampling kit; for 44 of these women with positive HR-HPV test results, 40 had the recommended triage Pap smear. The ICER per extra screened woman was 77.8[euro ] and 63.2[euro ] for the 'recall' and 'self-sampling' groups, respectively, relative to the 'no intervention' group.

Conclusions: Offering an in-home, return-mail kit for vaginal self-sampling with a dry swab is more effective and cost-effective than a recall letter in increasing participation in cervical cancer screening.

Figures

Figure 1
Figure 1
Procedure for the ‘self-sampling' group. Abbreviation: HPV, human papillomavirus.
Figure 2
Figure 2
Study flow chart and results. Abbreviations: HR-HPV+, positive for high-risk HPV and/or probable high-risk HPV; HR-HPV−, negative for high-risk HPV and probable high-risk HPV; UI, uninterpretable HPV test result. 95% confidence intervals are presented in brackets.

References

    1. Arbyn M, Anttila A, Jordan J, Ronco G, Schenck U, Segnan N, Wiener H, Herbert A, von Karsa L. European Guidelines for Quality Assurance in Cervical Cancer Screening. Second edition—summary document. Ann Oncol. 2010;21:448–458.
    1. Arbyn M, Raifu AO, Weiderpass E, Bray F, Anttila A. Trends of cervical cancer mortality in the member states of the European Union. Eur J Cancer. 2009;45:2640–2648.
    1. Arbyn M, Ronco G, Anttila A, CJLM Meijer, Poljak M, Ogilvie G, Koliopoulos G, Naucler P, Sankaranarayanan R, Peto J. Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer. Vaccine. 2012;30 (Suppl 5:F88–F99.
    1. Arbyn M, Verdoodt F, Snijders PJF, Verhoef VMJ, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao F-H, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15:172–183.
    1. Van Baars R, Bosgraaf RP, ter Harmsel BWA, Melchers WJG, Quint WGV, Bekkers RLM. Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol. 2012;50:3937–3943.
    1. Bais AG, van Kemenade FJ, Berkhof J, Verheijen RHM, Snijders PJF, Voorhorst F, Babović M, van Ballegooijen M, Helmerhorst TJM, Meijer CJLM. Human papillomavirus testing on self-sampled cervicovaginal brushes: an effective alternative to protect nonresponders in cervical screening programs. Int J Cancer. 2007;120:1505–1510.
    1. Belinson JL, Hu S, Niyazi M, Pretorius RG, Wang H, Wen C, Smith JS, Li J, Taddeo FJ, Burchette RJ, Qiao Y-L. Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: Implications for vaginal self-collection. Int J Cancer. 2010;127:1151–1157.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.
    1. Broberg G, Gyrd-Hansen D, Miao Jonasson J, Ryd M-L, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: Offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial. Int J Cancer. 2014;134:2223–2230.
    1. Cerigo H, Coutlée F, Franco EL, Brassard P. Dry self-sampling versus provider-sampling of cervicovaginal specimens for human papillomavirus detection in the Inuit population of Nunavik, Quebec. J Med Screen. 2012;19:42–48.
    1. Darlin L, Borgfeldt C, Forslund O, Hénic E, Dillner J, Kannisto P. Vaginal self-sampling without preservative for human papillomavirus testing shows good sensitivity. J Clin Virol. 2013;56:52–56.
    1. Darlin L, Borgfeldt C, Forslund O, Hénic E, Hortlund M, Dillner J, Kannisto P. Comparison of use of vaginal HPV self-sampling and offering flexible appointments as strategies to reach long-term non-attending women in organized cervical screening. J Clin Virol. 2013;58:155–160.
    1. Duport N, Salines E, Grémy I. [First results of the experimental evaluation of the French organized cervical cancer screening program, 2010–2012] Bull Epidémiol Hebd. 2014;13-14-15:228–234.
    1. Eperon I, Vassilakos P, Navarria I, Menoud P-A, Gauthier A, Pache J-C, Boulvain M, Untiet S, Petignat P. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing. BMC Cancer. 2013;13:353.
    1. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F.2013. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. . accessed 29 January 2014.
    1. Fontaine V, Mascaux C, Weyn C, Bernis A, Celio N, Lefèvre P, Kaufman L, Garbar C. Evaluation of combined general primer-mediated PCR sequencing and type-specific PCR strategies for determination of human papillomavirus genotypes in cervical cell specimens. J Clin Microbiol. 2007;45:928–934.
    1. French National Authority for Health 2002[Follow-up Guidelines for a Patient With an Abnormal Pap Smear Test Result. 2002 Updated Data].
    1. French National Authority for Health 2012. Choices in Methods for Economic Evaluation (Department of Economics and Public Health Assessment).
    1. Gakidou E, Nordhagen S, Obermeyer Z. Coverage of cervical cancer screening in 57 countries: low average levels and large inequalities. PLoS Med. 2008;5:e132.
    1. Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600) Br J Cancer. 2011;104:248–254.
    1. Gök M, Heideman DAM, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JWM, Voorhorst F, Beliën JAM, Babovic M, Snijders PJF, Meijer CJLM. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010;340:c1040.
    1. Gök M, van Kemenade FJ, Heideman DAM, Berkhof J, Rozendaal L, Spruyt JWM, Beliën JAM, Babovic M, Snijders PJF, Meijer CJLM. Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Int J Cancer. 2012;130:1128–1135.
    1. Goldie SJ, Kim JJ, Wright TC. Cost-effectiveness of human papillomavirus DNA testing for cervical cancer screening in women aged 30 years or more. Obstet Gynecol. 2004;103:619–631.
    1. Gravitt PE, Rositch AF. HPV self-testing and cervical cancer screening coverage. Lancet Oncol. 2014;15:128–129.
    1. Haguenoer K, Giraudeau B, Gaudy-Graffin C, de Pinieux I, Dubois F, Trignol-Viguier N, Viguier J, Marret H, Goudeau A. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study. Gynecol Oncol. 2014;134:302–308.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan A-W, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
    1. IARC 2005. IARC handbooks of cancer prevention: cervix cancer screening.
    1. Lăără E, Day NE, Hakama M. Trends in mortality from cervical cancer in the Nordic countries: association with organised screening programmes. Lancet. 1987;1:1247–1249.
    1. Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué X, Shah KV, Snijders PJF, Meijer CJLM. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348:518–527.
    1. Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013;104:e159–e166.
    1. Safaeian M, Herrero R, Hildesheim A, Quint W, Freer E, Van Doorn L-J, Porras C, Silva S, González P, Bratti MC, Rodriguez AC, Castle P. Comparison of the SPF10-LiPA system to the Hybrid Capture 2 Assay for detection of carcinogenic human papillomavirus genotypes among 5,683 young women in Guanacaste, Costa Rica. J Clin Microbiol. 2007;45:1447–1454.
    1. Sancho-Garnier H, Tamalet C, Halfon P, Leandri FX, Le Retraite L, Djoufelkit K, Heid P, Davies P, Piana L. HPV self-sampling or the Pap-smear: a randomized study among cervical screening nonattenders from lower socioeconomic groups in France. Int J Cancer. 2013;133:2681–2687.
    1. Schmeink CE, Bekkers RLM, LFAG Massuger, Melchers WJG. The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. Rev Med Virol. 2011;21:139–153.
    1. Snijders PJF, Verhoef VMJ, Arbyn M, Ogilvie G, Minozzi S, Banzi R, van Kemenade FJ, Heideman DAM, Meijer CJLM. High-risk HPV testing on self-sampled versus clinician-collected specimens: a review on the clinical accuracy and impact on population attendance in cervical cancer screening. Int J Cancer. 2013;132:2223–2236.
    1. Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T, Jr, Young N. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002;287:2114–2119.
    1. Szarewski A, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Edwards R, Lyons D, Walker J, Christison J, Frater A, Waller J. HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer. 2011;104:915–920.
    1. Tamalet C, Richet H, Carcopino X, Henry M, Leretraite L, Heid P, Leandri F-X, Sancho-Garnier H, Piana L. Testing for human papillomavirus and measurement of viral load of HPV 16 and 18 in self-collected vaginal swabs of women who do not undergo cervical cytological screening in Southern France. J Med Virol. 2010;82:1431–1437.
    1. Virtanen A, Anttila A, Luostarinen T, Nieminen P. Self-sampling versus reminder letter: effects on cervical cancer screening attendance and coverage in Finland. Int J Cancer. 2011;128:2681–2687.
    1. Virtanen A, Nieminen P, Luostarinen T, Anttila A. Self-sample HPV tests as an intervention for nonattendees of cervical cancer screening in Finland: a randomized trial. Cancer Epidemiol Biomarkers Prev. 2011;20:1960–1969.
    1. Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189:12–19.
    1. Wikström I, Lindell M, Sanner K, Wilander E. Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study. Br J Cancer. 2011;105:337–339.
    1. Zhang S-K, Ci P-W, Velicer C, Kang L-N, Liu B, Cui J-F, Chen F, Zhang X, Chang IJ, Roberts CC, Smith JS, Chen W, Qiao Y-L. Comparison of HPV genotypes and viral load between different sites of genital tract: the significance for cervical cancer screening. Cancer Epidemiol. 2014;38:168–173.

Source: PubMed

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