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NIHR Signal Self-testing kits for HPV could be a useful option to tackle low cervical screening rates in young women

Published on 6 December 2016

doi: 10.3310/signal-000341

Human Papilloma Virus (HPV) self-sampling kits and the opportunity to book appointments had the largest effect in improving cervical screening uptake for those not responding to initial prompts. However, uptake improved only slightly from 27% to 30%, when the kit was sent. A survey of non-attenders showed they value the convenience and privacy of self-testing.

This large NIHR trial tested a range of interventions to increase uptake among women eligible for their first cervical screening test. Sending information leaflets or giving online booking options before their first invitation had no effect on uptake within six months.

Screening uptake was twice as good in women who’d had HPV vaccination, but remained low in other groups. This suggests that motivation may be improved by providing information on HPV at vaccination.

Despite the small impact of HPV self-testing at 18 months this was estimated to be a cost effective use of NHS resources. The findings may be relevant to the recent decision to implement HPV testing as the primary screening test for cervical cancer, but self-testing in this context would need further evaluation.

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Why was this study needed?

Cervical cancer rates have almost halved since the UK cervical cancer screening programme started in the 1980s. It saves around 4,500 lives each year.

Yet the number of young women taking up screening is declining at a time when cervical cancer cases in under-35s are rising.

In Manchester, for example, just 30% of women take up their first screening offer aged 25. This is well short of the UK-wide target of 80% and the overall rate achieved for all eligible women in England in 2015 (73.5%).

Research suggests fear, embarrassment and perceived inconvenience of the screening test are among the reasons for poor uptake.

This NIHR-funded trial tested several approaches designed to increase screening uptake in young women, particularly in those not taking up their first screening invitation.

What did this study do?

This cluster-randomised control trial tested multiple interventions to boost uptake of cervical screening at first invite in women living in Manchester, England (aged 25) and Grampian, Scotland (aged 20). This was a large and ambitious trial of practice-based populations in two sizeable regions of the UK, known to have low uptake (Manchester) or previous HPV vaccination (Grampian)

Phase 1 randomly assigned around 20,000 women by GP practice to receive pre-screening-invitation information leaflets or no leaflets. Women in Manchester could additionally be randomised to the offer of online booking options or not.

In Phase 2, around 10,000 women who hadn’t taken up the screening offer within six months were randomised again to receive: home self-sampling kits for HPV sent out automatically (1) or on request (2), guidance from a nurse expert (3), the option of the nurse or self-sampling kit (4), an automatic screening appointment (5), or no intervention (6). Non-attenders were asked their reasons for declining screening.

Around 30% of women not taking up screening at Phase 1 were excluded from Phase 2 because of change of address or delay in setting up the interventions. This could make the interventions seem more effective than if all women had stayed in the study.

What did it find?

  • Distributing information leaflets before the screening invitation in Phase 1 had no impact on screening uptake. Three months after invite, 19% of both the leaflet and control groups had been screened, rising to 31% in both groups by six months. The proportions were similar when comparing three and six month uptake among those also offered online booking or not.
  • At Phase 2, automatically sending women a HPV self-sampling kit 7.5 months after first invite increased screening uptake within a year from 16.2% (no intervention) to 21.3%. (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.20 to 1.91).
  • Automatically booking a woman a general practice appointment (timed appointments) also increased uptake from 16.2% (no intervention) to 19.8%. (OR 1.41, 95% CI 1.14 to 1.74).
  • There were no significant differences in uptake between the other groups (sampling kit offered, nurse contact, or choice of either) and no intervention.
  • Only the HPV self-sampling kit remained beneficial 18 months after first screening invite: 30.0% screening uptake (self-sample kit) compared with 27.1% (no intervention).
  • The HPV self-sampling kit and giving an automatic appointment were both estimated to be cost effective at £8,434 and £7,593 for each year of quality life gained respectively. There was a greater than 90% probability that both of these interventions would fall beneath the NHS willingness-to-pay threshold.
  • When analysing factors associated with better screening uptake they found that in Scotland, girls previously vaccinated against HPV at age 12 or 13 were much more likely to attend screening aged 20. The difference in uptake six months after first invite was large: 40.1% in those vaccinated compared with 18.2% not vaccinated.
  • Non-attenders reported that they valued minimal contact in making screening appointments, convenience and privacy for administering the test.

What does current guidance say on this issue?

The UK National Screening Committee recommends all women aged 25 to 49 are offered cervical screening every three years, and every five years to women aged 50 to 64. At the time of the trial Scotland was offering screening from age 20.

The screening programme includes reminders to increase uptake, but does not include the pre-invitation leaflet or any other interventions tested in this new trial.

In January 2016 the UK National Screening Committee recommended making HPV testing the primary screening test following evidence it has advantages over the smear test and this will lead to significant workforce implications as practice changes and fewer cervical smears and cytology reading is required.

What are the implications?

There are still significant barriers to overcome to reach target levels of 80% screening uptake. HPV self-sampling had small impact, adding only 2.9% to the already low uptake figures. Nevertheless, alongside automatic booked appointments, these could be cost effective measures to boost numbers.

The strong link between past HPV vaccination and cervical screening uptake was notable and needs to be explored. It could be personal characteristics associated with preventative measures like vaccination or screening, or that women attending HPV vaccination are better informed on cervical cancer risk.

The impact of the new screening strategy and acceptability of HPV testing, in contrast to cervical cytology screening, will be awaited with interest, there will be a gradual transition.

Citation and Funding

Kitchener HC, Gittins M, Rivero-Arias O, et al. A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC). Health Technol Assess. 2016;20(68):1-138.

This project was funded by the National Institute for Health Research Health Technology Assessment programme.

Bibliography

Cancer Research UK. Cervical Cancer Screening. London: Cancer Research UK; 2016.

Ruth Stubbs. HPV primary screening in the cervical screening programme. London: Public Health England Screening Blogs; 2016.

UK National Screening Committee. The UK NSC recommendation on Cervical Cancer screening in women. London: Public Health England; 2015.

Why was this study needed?

Cervical cancer rates have almost halved since the UK cervical cancer screening programme started in the 1980s. It saves around 4,500 lives each year.

Yet the number of young women taking up screening is declining at a time when cervical cancer cases in under-35s are rising.

In Manchester, for example, just 30% of women take up their first screening offer aged 25. This is well short of the UK-wide target of 80% and the overall rate achieved for all eligible women in England in 2015 (73.5%).

Research suggests fear, embarrassment and perceived inconvenience of the screening test are among the reasons for poor uptake.

This NIHR-funded trial tested several approaches designed to increase screening uptake in young women, particularly in those not taking up their first screening invitation.

What did this study do?

This cluster-randomised control trial tested multiple interventions to boost uptake of cervical screening at first invite in women living in Manchester, England (aged 25) and Grampian, Scotland (aged 20). This was a large and ambitious trial of practice-based populations in two sizeable regions of the UK, known to have low uptake (Manchester) or previous HPV vaccination (Grampian)

Phase 1 randomly assigned around 20,000 women by GP practice to receive pre-screening-invitation information leaflets or no leaflets. Women in Manchester could additionally be randomised to the offer of online booking options or not.

In Phase 2, around 10,000 women who hadn’t taken up the screening offer within six months were randomised again to receive: home self-sampling kits for HPV sent out automatically (1) or on request (2), guidance from a nurse expert (3), the option of the nurse or self-sampling kit (4), an automatic screening appointment (5), or no intervention (6). Non-attenders were asked their reasons for declining screening.

Around 30% of women not taking up screening at Phase 1 were excluded from Phase 2 because of change of address or delay in setting up the interventions. This could make the interventions seem more effective than if all women had stayed in the study.

What did it find?

  • Distributing information leaflets before the screening invitation in Phase 1 had no impact on screening uptake. Three months after invite, 19% of both the leaflet and control groups had been screened, rising to 31% in both groups by six months. The proportions were similar when comparing three and six month uptake among those also offered online booking or not.
  • At Phase 2, automatically sending women a HPV self-sampling kit 7.5 months after first invite increased screening uptake within a year from 16.2% (no intervention) to 21.3%. (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.20 to 1.91).
  • Automatically booking a woman a general practice appointment (timed appointments) also increased uptake from 16.2% (no intervention) to 19.8%. (OR 1.41, 95% CI 1.14 to 1.74).
  • There were no significant differences in uptake between the other groups (sampling kit offered, nurse contact, or choice of either) and no intervention.
  • Only the HPV self-sampling kit remained beneficial 18 months after first screening invite: 30.0% screening uptake (self-sample kit) compared with 27.1% (no intervention).
  • The HPV self-sampling kit and giving an automatic appointment were both estimated to be cost effective at £8,434 and £7,593 for each year of quality life gained respectively. There was a greater than 90% probability that both of these interventions would fall beneath the NHS willingness-to-pay threshold.
  • When analysing factors associated with better screening uptake they found that in Scotland, girls previously vaccinated against HPV at age 12 or 13 were much more likely to attend screening aged 20. The difference in uptake six months after first invite was large: 40.1% in those vaccinated compared with 18.2% not vaccinated.
  • Non-attenders reported that they valued minimal contact in making screening appointments, convenience and privacy for administering the test.

What does current guidance say on this issue?

The UK National Screening Committee recommends all women aged 25 to 49 are offered cervical screening every three years, and every five years to women aged 50 to 64. At the time of the trial Scotland was offering screening from age 20.

The screening programme includes reminders to increase uptake, but does not include the pre-invitation leaflet or any other interventions tested in this new trial.

In January 2016 the UK National Screening Committee recommended making HPV testing the primary screening test following evidence it has advantages over the smear test and this will lead to significant workforce implications as practice changes and fewer cervical smears and cytology reading is required.

What are the implications?

There are still significant barriers to overcome to reach target levels of 80% screening uptake. HPV self-sampling had small impact, adding only 2.9% to the already low uptake figures. Nevertheless, alongside automatic booked appointments, these could be cost effective measures to boost numbers.

The strong link between past HPV vaccination and cervical screening uptake was notable and needs to be explored. It could be personal characteristics associated with preventative measures like vaccination or screening, or that women attending HPV vaccination are better informed on cervical cancer risk.

The impact of the new screening strategy and acceptability of HPV testing, in contrast to cervical cytology screening, will be awaited with interest, there will be a gradual transition.

Citation and Funding

Kitchener HC, Gittins M, Rivero-Arias O, et al. A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC). Health Technol Assess. 2016;20(68):1-138.

This project was funded by the National Institute for Health Research Health Technology Assessment programme.

Bibliography

Cancer Research UK. Cervical Cancer Screening. London: Cancer Research UK; 2016.

Ruth Stubbs. HPV primary screening in the cervical screening programme. London: Public Health England Screening Blogs; 2016.

UK National Screening Committee. The UK NSC recommendation on Cervical Cancer screening in women. London: Public Health England; 2015.

A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

Published on 1 September 2016

Kitchener HC, Gittins M, Rivero-Arias O, Tsiachristas A, Cruickshank M, Gray A, Brabin L, Torgerson D, Crosbie EJ, Sargent A, Roberts C

Health Technology Assessment Volume 20 Issue 68 , 2016

Background Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience. Objectives To measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women. Design A cluster randomised trial based on general practices performed in two phases. Setting Primary care in Greater Manchester and the Grampian region in Scotland. Participants Phase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months. Interventions Phase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices. Main outcome measures Uplift in screening compared with control practices, cost-effectiveness of interventions, and the women’s preferences explored in a discrete choice experiment. Results The pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06; p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20; p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53; p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91; p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74; p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%. Conclusion Women receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.

Cervical cancer starts out with small changes in the cells of the cervix that could, in some cases, lead to cancer if left untreated.

The UK cervical screening programme is a way of preventing cancer development by finding and treating early any abnormal changes in the cervix in apparently healthy women.

The first screening test involves a nurse or doctor taking a sample of cells from the cervix with a small brush before sending them to a laboratory to be checked for abnormalities.

The laboratory look at the structure of the cervical cells - called cytology - which many people know better as the smear test.

Test results showing cell abnormalities are followed up with further diagnostic tests and possibly treatment.

In some cases, samples are also tested for a virus called human papilloma virus (HPV) that increases the risk of cervical cancer.

Read more about the full cervical screening programme.

Expert commentary

The NHS Cervical Screening Programme has been hugely successful in reducing the incidence of cervical cancer by more than 40% since the 1970s. The target acceptance rate is 80% but it has been low amongst young women receiving their first few invitations for more than a decade now.

No single strategy in this trial provided the solution, but the results after HPV vaccination were reassuring. Continued efforts must be made to woo young women and imaginative local strategies employed. Perhaps building on the previous vaccination experience and effort might be fruitful?

Professor Julietta Patnick, Cancer Epidemiology Unit, University of Oxford