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Clinic-Delivered Non-Speculum HPV Sampling for Cervical Screening

A study carried out in east London found that offering clinic-delivered non-speculum human papillomavirus (HPV) sampling increased cervical screening uptake among lapsed attendees. This approach could provide an opportunity to address some of the known barriers to both conventional and self-sampling methods.

Using electronic patient record systems, 809 eligible women were recruited from 10 general practices in the boroughs of Tower Hamlets or City and Hackney between August 2018 and November 2018. Eligible women were those aged 50-64 years on the search date, who were at least 12 months overdue for a cervical screening test and had attended at least once in the previous 15 years. Ultimately, 393 eligible women were randomised to the intervention arm and 391 to the control.

Two Options Offered

Women in the intervention arm were sent an invitation letter, a study information leaflet, an HPV information sheet, and a self-sampling kit postal order form with a prepaid return envelope. The invitation letter offered two options:

  1. Booking an appointment at their GP practice for a clinician-taken non-speculum sample, or
  2. Ordering a self-sampling kit (using the postal order form or telephone).

To address any potential difficulty in booking appointments, GP practices were asked to provide additional routes to make it easier for women to book screening appointments.

Women in the control arm received usual care: an invitation for cervical screening every 5 years until age 64 and in-between invitations if they were overdue for screening.

The intervention group also received a questionnaire regarding their experience of the test, previous barriers to screening, and future screening preferences.

Results of the Study

Four months post-randomisation, screening uptake was 20.4% in the intervention arm compared to 4.9% in the control arm (absolute difference 15.5%; 95% CI 11.0% to 20.0%; P<0.001). This difference was maintained at 12 months (30.5% vs 13.6%; absolute difference 17.0%; 95% CI 11.3% to 22.7%; P<0.001).

Of the women screened in the intervention arm, 22.5% opted for the non-speculum clinician-taken sample approach, 35.8% opted for self-sampling, and 41.7% chose the conventional screening method.

The intervention proved to be particularly valuable in re-engaging women who had not been screened in the previous 1 to 5 years, but was less effective amongst women whose lapse in attendance was longer. At 4 months, the uptake of screening among those who had not been screened for 1 to 5 years was 23.9%. This compares to a rate of 12.4% in those who were 5-10 years overdue. This remained the same at 12 months (36.0% vs 18.2%).

Ethnicity appeared to play a role in preference for screening method. In the intervention group, half of screened women from White backgrounds self-sampled (50.7%), whereas the majority of women from Asian (53.3%), Black (71.4%), and mixed/other/unknown backgrounds (66.7%) attended for conventional screening.

In the questionnaires, non-speculum clinician sampling and self-sampling scored similarly in measures of acceptability and confidence in doing the test properly.

Important to Have a Choice

However, a higher proportion of self-samplers were "not at all" or "not very" confident in the test accuracy (64%). More women who had the non-speculum test experienced embarrassment - 27.8% vs. 4.8% in the self-sample group. A high proportion in both groups (72.2% non-speculum, 88.1% self-sampling) "agreed" or "strongly agreed" that it was important to have a choice of tests. Future screening preferences aligned with the sampling option chosen.

It is well documented that the speculum examination is a barrier to cervical screening and can become particularly uncomfortable for older women due to vaginal atrophy, increasing body mass index, and musculoskeletal problems. While self-administered HPV sampling is an alternative option for these women, studies have consistently shown that women are concerned about the accuracy of self-sampling. Based on the findings of this study, clinician-taken non-speculum HPV testing is an approach which might prove useful in addressing these barriers.

Presenting the findings in the British Journal of General Practice, the authors say: "It appears increasingly likely that offering a choice of test will be important to ensure high uptake. Non-speculum clinician sampling could be a valuable supplement to self-sampling and warrants further research in larger studies. The rollout of HPV primary testing in many developed countries, including England, makes the introduction of these alternative approaches increasingly feasible."

However, they caution that validation of test performance using paired sampling studies and an assessment of resource and workload implications are still required.