Opportunistic offering of self-sampling to non-attenders within the English cervical screening programme: a pragmatic, multicentre, implementation feasibility trial with randomly allocated cluster intervention start dates (YouScreen)

Abstract

Background: Self-sampling has game-changing potential to tackle the declining participation and inequities seen in many organised cervical screening programmes. Wide variation in uptake between settings and mode of kit offer highlight the importance of local piloting. Furthermore, harnessing the benefits of self-sampling in real-world settings has been surprisingly challenging. The YouScreen study estimated the impact of offering self-sampling to non-attenders within the English Programme and evaluated large-scale opportunistic offering of self-sampling in primary care.

Methods: A pragmatic modified stepped-wedge implementation feasibility trial with randomly-allocated cluster intervention start dates at primary care practices in England (133 participating, 62 non-participating). Eligible women were aged 25-64 years and ≥6 months overdue for screening ("non-attenders"). Between January 13, 2021 and 30 November, 2021 self-sampling kits were distributed to non-attenders via an opportunistic offer in primary care when they consulted for any reason and direct mailout to those unscreened 15-months after routine invitation. Primary outcomes were the proportion of non-attenders screened each month; change in coverage; and uptake (90 days). YouScreen is registered with ISRCTN:12759467.

Findings: 8338 women provided self-samples following recruitment between January 13, 2021 and 30 November, 2021. Self-samples were returned from 65.5% (6061/9248) who accepted an opportunistically offered kit and 12.9% (2777/17,604) directly-mailed kits. Responders were representative of the ethnically diverse and deprived underlying non-attendee population (64% ethnic minority groups, 60% from the two most deprived national quintiles). The self-sampling intervention resulted in a 22% (95% CI 18-26) increase in non-attenders screened per month (per-protocol analysis) and 12% (95% CI 9-15) (intention-to-treat analysis). Change in coverage at participating (mean intervention duration 7.5 months) vs non-participating practices was 1.6% (95% CI 0.4-2.8). Adverse effects were not formally collected.

Interpretation: Opportunistically offering self-sampling to under-screened women in primary care could increase coverage in England and potentially reach underserved populations.

Funding: North Central London and North East London Cancer Alliance.

Keywords: Cervical cancer; Cervical intraepithelial neoplasia; Human papillomavirus; Mass screening; Self-sampling.

Fig. 1

∗Estimate from aggregate GP (general practitioner) data downloaded from participating GP practices for women aged 25.5–64 y at least 6 months overdue cervical screening on 15th February 2021 (or 15th March 2021 for five GP practices missing from February 2021 data download). ∗∗Numbers are based on aggregate GP data which are approximate due to underrecording of opportunistic offers and women who may have left the GP practice during the trial. ∗∗∗Includes 154 women deemed by laboratory to be “ineligible” (146 <6 months overdue when self-sample received, 8 not on routine recall due to previous abnormal result), 350 women whose samples had insufficient identifiers or were missing the laboratory request form, 81 women who returned samples after study end, 10 women for other reasons Dashed lines indicate that numbers are approximate. Numbers may not add up as some women were offered both kit types and/or returned more than one kit type. Women returning more than one type are classified according to the first kit returned. Insufficient/invalid = unable to produce a valid result due to negative beta-globin or other sample analytical issues. Repeat kits issued to eligible women with rejected kits or an invalid/insufficient Human Papillomavirus (HPV) result. HPV self-sample result shown is for the valid HPV result if obtained. Of the 96 women with insufficient/invalid self-sample results, 21 tested HPV negative but were reported as invalid because they were received >14 days after the sample was taken 4 women whose self-samples were analysed were subsequently discovered to have no cervix and are excluded from the reporting of clinical results in the text (3 HPV negative, 1 HPV positive). Women seen in colposcopy following negative/normal clinician-taken follow up results were presumably symptomatic referrals (e.g. abnormal bleeding, cervical ectropion or polyps).

Fig. 2

(a) Overview of YouScreen trial ("step-wedge") intervention. (b) YouScreen trial timeline. NHS, National Health Service.