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Cervical cancer screening

Self-collected vaginal samples

Clinical question

GUIDELINE UPDATES - This guideline was last updated 7/1/2022

Background

Only around five in 10 women participate in the National Cervical Screening Program (NCSP) at the recommended interval.[1] Participation at the recommended interval is less than 50% in the Northern Territory, and in outer regional, remote, or very remote areas.[1] Some of the groups of women and other people with a cervix who are underscreened include those who identify as Aboriginal and Torres Strait Islanders, are culturally and linguistically diverse, are socioeconomically disadvantaged, have experienced sexual assault, have a disability, identify as lesbian or bisexual, or are trans men and gender diverse people with a cervix who do not identify as women. 

Data from the Victorian Cervical Cytology Register (VCCR) show that 74% of women diagnosed with invasive cervical cancer over 2012-2014 have never been screened or have participated in the screening program but were overdue for a recommended cytology test at the time of their cancer diagnosis.[2,3,4] Self-collection of human papillomavirus (HPV) test samples has been shown to overcome some of the barriers to undergoing a screening test that some women experience. Providing HPV self-collection kits to never-screened and under-screened women has been shown to improve screening participation in international studies.[5] 

Under the renewed NCSP, HPV testing on self-collected samples with limited eligibility was introduced in December 2017. From 1 July 2022, HPV testing on self-collected samples will be available as a choice to all women eligible for routine screening or for a follow-up HPV test. The clinical guidelines define the pathways for people who have a positive self-collected sample. There are some groups of people who require co-testing and will therefore require a clinician- collected sample.  

Evidence

2013 MSAC systematic review

The MSAC evaluation assessed the comparative safety and effectiveness of including self-collected samples for HPV testing for never-screened and under-screened women, to supplement the organised screening program using clinician-collected samples for HPV testing, compared with the existing collection protocol.[7] 

The MSAC assessment of accuracy of self-collected samples was based on 10 level III-2 diagnostic accuracy studies conducted in a screening setting, which were included in a systematic review.[5] Evidence for adherence rates was obtained from a randomised controlled trial[8] and two cohort studies.[9][10]

The 2013 MSAC systematic review made the following conclusions:[7]

  • The accuracy of HPV testing using self-collected samples varies between different types of sampling devices and HPV tests.
  • HPV tests using self-collected samples have moderate-to-high sensitivity and comparably high specificity for detecting cervical intraepithelial neoplasia grade 2 or higher (CIN2+), compared with clinic HPV testing in nine of 10 studies identified, with a relative sensitivity of 0.62–1.00 and relative specificity of 0.93–1.00.
  • High rates of adherence to screening follow-up have been reported among previously unscreened women with a positive HPV test result from a self-collected sample.

Other evidence

A more recent meta-analysis[11] found that the sensitivity and specificity of HPV testing to detect CIN2+ in self-collected samples were similar to those for clinician-collected samples when using validated PCR-based HPV assays. When using signal amplification-based HPV assays, self-collected samples showed lower sensitivity than clinician-collected samples.[11][12]

Two studies conducted in Victoria suggest that offering self-collection is likely to be acceptable to Australian women who have not been screened recently.[13][14] One of these, a randomised controlled trial, additionally found that offering self-collection was more effective than a reminder letter in encouraging women who were unscreened or overdue for screening to undergo a round of screening.[15] Overall, 75.7% of women with a positive oncogenic HPV (any type) test result had the appropriate clinical follow-up within 6 months. Among 45 women with a positive oncogenic HPV (16/18) test result, 28 (62.2%) attended for colposcopy within 6 months, and attendance for colposcopy was lower among women with negative or LSIL cytology (18/27 attended) than among women with HSIL cytology (8/8 attended).[15] The authors suggested that medical practitioners may not have referred women for colposcopy when subsequent cytology was negative.[15] The trial protocol had recommended colposcopy referral for women with a positive oncogenic HPV (16/18) test result, and did not require or actively recommend that cytology be collected prior to referral (this was at the discretion of the healthcare professional), [16] however, cytology was collected from 35 of the 37 women who attended for any follow-up.[15] 

A modelled analysis found that undergoing even one round of screening could substantially reduce an unscreened woman’s risk of cervical cancer over her lifetime, by around 41% if this occurred at age 30 or 40.[12] The authors noted that benefits of self-collection would be maximised by using a sufficiently accurate HPV test that had capacity to perform partial genotyping for HPV 16/18.[12

2021 MSAC review

In 2021, the Medical Services Advisory Committee (MSAC) reviewed an application from the National Cervical Screening Program requesting expansion of the eligibility to participate in cervical screening using self-collection. The Self-Collection Expert Advisory Group was convened to guide this review, and to provide advice on policy, implementation and consultation. [17] 

MSAC noted the large body of evidence showing no material difference in the diagnostic accuracy of HPV testing between using self-collected and clinician-collected samples (relative sensitivity = 0.98; 95% CI: 0.96 to 1.01; relative specificity = 0.99; 95% CI: 0.98 to 1.01). [17] 

MSAC concluded that HPV testing using self-collected samples is just as accurate as using clinician-collected samples, provided a PCR based assay was used. MSAC supported expanding access to self-collection to include everyone eligible for cervical screening, giving all eligible people a choice in screening method. MSAC considered self-collection to be safe and effective, and that it would likely increase participation in cervical screening.[17] 

MSAC advised that expanding self-collection is an important option to increase access to screening, particularly for people who may feel uncomfortable with a clinician collecting their sample. People who choose to use self-collection would still access cervical screening through their healthcare provider, to allow for education and engagement.

2021 evidence review

A general review of the literature was undertaken to identify studies in Australia assessing the acceptability to women of screening on a self-collected sample (including uptake of this option) and adherence to follow-up among women in whom HPV is detected. Eight articles assessing acceptability were identified,18-25 six of which reported on findings for women who were under- or never-screened and who had used or been offered self-collection.18-23 Two other studies were among women with a mix of screening histories who were asked for opinions on self-collection but had not used it,24,25 and in one case were asked about home-based self-collection rather than the clinic-based model as has been adopted in Australia.24 In all studies where women had been offered or used self-collection there was a high level of acceptability of self-collection. The two studies among women with a mix of screening histories and who had not used self-collection reported that many women would prefer to continue to be screened on a clinician-collected sample, especially if they were screening regularly, but nevertheless there was high acceptability of self-collection being offered as an alternative option.24,25 Women who indicated they would prefer a healthcare professional to collect the sample expressed concerns about performing sample collection correctly. Most women who had used self-collection reported they found it easy to perform, less embarrassing, and a convenient option. 

Only three studies provided information about adherence to recommended follow-up after a self-collected sample,18,20,21 all of which were undertaken with under-screened women. The findings of these studies may therefore have limited applicability to the general screening population. The number of women requiring follow-up was generally small (range: 14-140). Adherence to follow-up ranged from 52 to 82%. Study findings were inconsistent as to whether women with HPV (16/18) detected (colposcopy recommended) were more or less likely to have completed follow-up than women with HPV (not 16/18) detected. 

The eight identified articles were reporting on six different studies or pilot studies of self-collection (for two studies there was both a quantitative and a qualitative paper). Three of these six studies were conducted in, or reported findings specifically for, Aboriginal or Torres Strait Islander women18,19, 25 (see Screening in Aboriginal and Torres Strait Islander women). Each of these studies reported a high level of acceptability of self-collection as an alternative option.

Recommendations

Flowchart 6.1. Cervical screening pathway for primary oncogenic HPV screening (HPV tests on clinician-collected or self-collected samples)

MSAC evidence-based recommendation
REC6.1: Eligibility for screening on a self-collected sample to include all people eligible for cervical screening
Anyone who is eligible for cervical screening (people with a cervix aged 25-74 years who have ever been sexually active) should be offered the choice of HPV testing on a self-collected vaginal sample or on a clinician-collected sample.
Practice Point

REC6.16: Informed choice for patients about self-collection
When deciding whether to choose self-collection or clinician collection, people must be given clear information by the supervising healthcare professional about the likelihood that HPV may be detected and, if so, what follow-up will be required. If a person chooses self-collection then the healthcare professional should provide information about how to collect the sample and how they will receive the test results.

Among those attending for a routine screening test, approximately 2% have HPV16/18 detected and approximately 6% have HPV (not 16/18) detected, although the latter varies by age.

Practice Point

REC6.17: Settings where self-collection can be performed
Cervical screening on a self-collected vaginal sample needs to be ordered and overseen by a healthcare professional*. Patients attending an in-person consultation should be encouraged to collect a sample while they are still at the clinic, as sample collection is considered more likely in this context. The healthcare professional is not required to observe the patient collecting their sample unless this is the patient’s preference. 

However, with the aim to maximise participation in cervical screening, collection of the sample can occur in any setting that the healthcare professional* ordering the test believes is appropriate, including in the context of a telehealth consultation. The healthcare professional should facilitate access to screening, and the pathology laboratory should deliver the results to the requesting healthcare professional who will be responsible for informing patients of their results and any required follow-up. Within these constraints, healthcare professionals and laboratories have flexibility to develop models of screening that best meet the needs of their communities. 

* Only doctors and nurse practitioners can sign the pathology request for tests under current MBS rules.

Practice Point
REC6.18 Assistance with sample self-collection
Women who have difficulty collecting a lower vaginal sample by themselves could be assisted to do so by the provider. Alternatively the provider could collect the sample using a self-collection swab without using a speculum. A sample collected in this way is still classified as self-collection on the pathology request form.
Practice Point
REC6.19 Support for underscreened women
Women in whom HPV (any type) is detected in a self-collected sample and who were overdue for screening may require additional and individualised support to progress along the clinical pathway, and access to follow-up services where they will receive sensitive treatment. This additional support may involve, for example, reassurance and explanation of the screening pathway and follow-up procedures, longer appointments, or additional follow-up contact.
Practice point
REC6.20 Indication for genital inspection
Routine genital inspection is not indicated in all people attending for cervical screening, but could still be offered to people who undergo screening on a self-collected sample with any clinical indication that genital inspection is appropriate or who are from populations who are at high risk for vulvar disease.
Practice point

REC6.21 Follow-up HPV test after initial self-collected screening sample
When follow-up HPV testing is required after an initial positive oncogenic HPV test result, the sample may be self-collected or collected by a clinician. 

The woman’s healthcare professional should advise the woman of the follow-up that will be recommended if HPV is detected, and explain that a clinician-collected sample allows for reflex LBC to be performed on the same sample, potentially avoiding the need for an additional visit to collect a cervical sample for LBC. HPV testing is not repeated on the clinician-collected sample in this circumstance. 

Approval: 1-Feb-2021

Note: recommendation numbering changed Feb 2021, this was previously 6.14

Benefits and harms

Women who are eligible for the self-collection pathway will benefit by participation in screening, especially if disease is detected and treated. They will also benefit by being reassured that they are at low risk of cervical cancer if oncogenic HPV is not detected. 

Some women who choose to be screened using self-collection may be more anxious about cervical screening than other women and will need special consideration regarding reassurance and explanation of the screening pathway and the procedure. Women in whom HPV is detected will require a clinician-collected cervical sample for LBC and should be guided through this process in a sensitive and culturally appropriate manner. Women in whom HPV (16/18) is detected can have this sample collected at colposcopy. It is also important that health professionals communicate the meaning of HPV test results in a sensitive and culturally appropriate manner. 

Providing flexibility for collection of a vaginal sample to occur in any setting the healthcare professional overseeing the test considers to be appropriate could further reduce barriers to cervical screening for under-screened and never-screened groups including rural and remote communities, people from diverse cultural and faith backgrounds, and LGBTIQ communities.

See Section 5. Benefits, harms and cost-effectiveness of cervical screening in the renewed NCSP.

Health system implications of these recommendations

Clinical practice

When deciding whether to choose self-collection or clinician collection, people must be given clear information by the supervising healthcare professional about the probability that HPV will be detected and, if so, what follow-up will be required. Among those attending for a routine screening test, approximately 2% have HPV16/18 detected and approximately 6% have HPV (not 16/18) detected, although the latter varies by age. If a person chooses self-collection then the healthcare professional should provide appropriately tailored information about how to collect the sample and how they will receive the test results.

Resourcing

If people who have been regular participants in the NCSP switch to using self-collection, they may require two visits to their healthcare provider, which will increase the costs of the program. However, this is only expected to affect people in whom HPV (not 16/18) is detected, around 6% of all participants attending for routine screening.

Barriers to implementation

Many people may be unaware of the self-collection option. Healthcare professionals who identify individuals who are never-screened or overdue for screening are encouraged to opportunistically offer cervical screening and the choice of self-collection or clinician-collection. 

Women in whom HPV is detected may not undergo recommended further assessment, which includes taking a cervical sample for LBC and/or colposcopy. 

It is possible that some healthcare professionals may choose to delay colposcopy referral for women with a positive oncogenic HPV (16/18) test result until after they have collected a cervical sample for LBC. However, women who have a positive HPV (16/18) test result should be referred directly to colposcopy and the cervical sample for LBC will collected by the colposcopist. 

Key messages to educate women and healthcare professionals about the self-collection option and subsequent management of any abnormalities will be developed as part of implementation planning to support this updated guideline.

See the National Cervical Screening Program Policy.

Author(s):

  • Professor Karen Canfell — Author
  • Professor Marion Saville — Author
  • A/Professor Megan Smith — Author
  • Professor Deborah Bateson – Co-author
  • A/Professor Alison Brand — Co-author
  • Ms Kirsteen Fleming – Co-author
  • Dr Vivienne Milch – Co-author
  • Dr Marsali Newman – Co-author
  • A/Professor Lisa Whop – Co-author
  • Professor Bruce Armstrong — Contributor
  • Professor Ian Hammond — Contributor
  • Cancer Council Australia Cervical Cancer Screening Guidelines Working Party — Co-author

References

  1. Australian Institute of Health and Welfare. Cervical screening in Australia 2012–2013. Cancer series no. 93. Cat. no. CAN 91. Canberra: AIHW; 2015 Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129550872.
  2. Victorian Cervical Cytology Registry. Statistical Report 2013. Carlton South: The Victorian Cervical Cytology Registry(VCCR); 2013 Available from: http://www.vccr.org/site/VCCR/filesystem/documents/dataandresearch/StatisticalReports/VCS_StatisticsReport_2013_Web_SinglePages_Final.pdf.
  3. Snijders PJ, Verhoef VM, Arbyn M, Ogilvie G, Minozzi S, Banzi R, et al. 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 May 15;132(10):2223-36 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22907569.
  4. National Health and Medical Research Council. Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities. Canberra: NHMRC; 2005.
  5. Medical Services Advisory Committee. National Cervical Screening Program renewal: executive summary. Report November 2013.MSAC application no. 1276. Assessment report. Canberra: Australian Government Department of Health; 2014 Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/E6A211A6FFC29E2CCA257CED007FB678/$File/Executive%20Summary%20notated%2013.6.14.pdf.
  6. Tamalet C, Le Retraite L, Leandri FX, Heid P, Sancho Garnier H, Piana L. Vaginal self-sampling is an adequate means of screening HR-HPV types in women not participating in regular cervical cancer screening. Clin Microbiol Infect 2013 Jan;19(1):E44-50 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23137168.
  7. Szarewski A, Cadman L, Mallett S, Austin J, Londesborough P, Waller J, et al. Human papillomavirus testing by self-sampling: assessment of accuracy in an unsupervised clinical setting. J Med Screen 2007;14(1):34-42 Available from: http://www.ncbi.nlm.nih.gov/pubmed/17362570.
  8. Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, et al. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ 2010 Mar 11;340:c1040 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20223872.
  9. Arbyn M, Castle PE. Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program. Cancer Epidemiol Biomarkers Prev 2015 May;24(5):769-72 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25713024.
  10. Smith M, Lew JB, Simms K, Canfell K. Impact of HPV sample self-collection for underscreened women in the renewed Cervical Screening Program. Med J Aust 2016 Mar 21;204(5):194 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26985849.
  11. Mullins R, Scalzo K, Sultana F. Self-sampling for cervical screening: could it overcome some of the barriers to the Pap test? J Med Screen 2014 Dec;21(4):201-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25312640.
  12. Sultana F, Mullins R, English DR, Simpson JA, Drennan KT, Heley S, et al. Women's experience with home-based self-sampling for human papillomavirus testing. BMC Cancer 2015 Nov 4;15:849 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26536865.
  13. Sultana F, English DR, Simpson JA, Drennan KT, Mullins R, Brotherton JM, et al. Home-based HPV self-sampling improves participation by never- and under-screened women: Results from a large randomised trial (iPap) in Australia. Int J Cancer 2016 Feb 6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26850941.
  14. Sultana F, English DR, Simpson JA, Brotherton JM, Drennan K, Mullins R, et al. Rationale and design of the iPap trial: a randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never- and under-screened women in Australia. BMC Cancer 2014 Mar 19;14:207 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24646201.
  15. Sultana F, English DR, Simpson JA, Drennan KT, Mullins R, Brotherton JM, et al. Home-based HPV self-sampling improves participation by never- and under-screened women: Results from a large randomised trial (iPap) in Australia. Int J Cancer 2016 Feb 6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26850941.
  16. Sultana F, English DR, Simpson JA, Brotherton JM, Drennan K, Mullins R, et al. Rationale and design of the iPap trial: a randomized controlled trial of homebased HPV self-sampling for improving participation in cervical screening by never and under-screened women in Australia. BMC Cancer 2014 Mar 19;14:207 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24646201.
  17. Medical Services Advisory Committee. MSAC application no. 1664 (public summary document). 2021 Apr. Available from: http://www.msac.gov.au/internet/msac/publi shing.nsf/Content/69F7A5B132EA653ECA258646001B5CD5/$File/1664%20 Final%20PSD%20-%20Mar-Apr%202021.pdf (viewed Aug 2021).
  18. Dutton T, Marjoram J, Burgess S, et al. Uptake and acceptability of human papillomavirus self-sampling in rural and remote aboriginal communities: evaluation of a nurse-led community engagement model. BMC Health Serv Res 2020;20(1):398 doi: 10.1186/s12913-020-05214-5.
  19. McLachlan E, Anderson S, Hawkes D, et al. Completing the cervical screening pathway: Factors that facilitate the increase of self-collection uptake among underscreened and never-screened women, an Australian pilot study. Current Oncology 2018;25(1):e17-26 doi: 10.3747/co.25.3916.
  20. Saville M, Hawkes D, Mclachlan E, et al. Self-collection for under-screened women in a National Cervical Screening Program: pilot study. Current Oncology 2018;25(1):e27-e32 doi: 10.3747/co.25.3915.
  21. Sultana F, English DR, Simpson JA, et al. Home-based HPV self-sampling improves participation by never- and under-screened women: Results from a large randomised trial (iPap) in Australia. Int J Cancer 2016 doi: 10.1002/ijc.30031.
  22. Sultana F, Mullins R, English DR, et al. Women's experience with home-based self-sampling for human papillomavirus testing. BMC Cancer 2015;15:849 doi: 10.1186/s12885-015-1804-x.
  23. Creagh NS, Zammit C, Brotherton JM, et al. Self-collection cervical screening in the renewed National Cervical Screening Program: a qualitative study. Med J Aust 2021;215(8):354-58 doi: 10.5694/mja2.51137.
  24. Mullins R, Scalzo K, Sultana F. Self-sampling for cervical screening: could it overcome some of the barriers to the Pap test? Journal of medical screening 2014;21(4):201-6 doi: 10.1177/09691413145552470969141314555247 [pii].
  25. Moxham R, Moylan P, Duniec L, et al. Knowledge, attitudes, beliefs, intentions and behaviours of Australian Indigenous women from NSW in response to the National Cervical Screening Program changes: a qualitative study. The Lancet regional health. Western Pacific 2021;13:100195 doi: 10.1016/j.lanwpc.2021.100195.

WEBSITE UPDATES - This website was last updated 7/1/2022

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