ALOHA – A LOndon HPV Self SAmpling pilot
Research type
Research Study
Full title
Self-sampling for HPV testing in cervical screening nonattenders in London
IRAS ID
205691
Contact name
Peter Sasieni
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Underscreened women are at the highest risk of developing cervical cancer, yet the number of women attending cervical screening continues to fall. A potential solution is to offer self-sampling for HPV (human papillomavirus) testing. Self-sampling addresses many of the barriers to conventional screening (cervical cytology): women can take their own sample, in private and at a time and place of their choosing. Self-sampling is slightly less accurate than HPV testing on clinician-taken samples, so would not be suitable as a primary screening test. UK studies have already shown that HPV self-sampling can increase screening uptake in non-attenders but the optimal approach for offering self-sampling kits (SSK) is unclear. London has consistently had the lowest cervical screening uptake nationally making it an ideal population to assess the potential for self-sampling and provide the evidence-base for its implementation in England. \n\nThis will be a randomised-controlled pilot to establish the optimal study design for a large implementation trial of self-sampling. The study will run for 12 months at 10-12 London GP practices in Hounslow. Eligible women will be aged 25-64, >6 months overdue cervical screening. GP practices will be randomised (1:1) to either an intervention arm: offering self-sampling opportunistically when eligible women consult for any reason) or usual care. Women (both arms) who have never been screened or reach the 15 or 27 month anniversary of their screening test due date will also be randomised to either 1) usual care, 2) receiving a letter inviting them to order a SSK, or 3) receiving a SSK in the post. Uptake of self-sampling will be assessed for each approach. Cervical screening data for all eligible women will be collected from GP records for 12 months after recruitment ends to assess changes in screening coverage. The study will be funded by a CRUK programme grant.
Lay summary of study results: Background:
Offering self-sampling to cervical screening non-attenders has been shown to increase screening uptake, though uptake rates are setting-specific, highly variable and are lower in UK-based studies. We carried out a pilot study to explore self-sampling uptake using different approaches for offering kits.Methods:
We performed a pragmatic randomized controlled trial offering self-sampling to women aged 25-64 years who were overdue cervical screening. There were two levels of randomization: 13 GP practices were randomised (1:1) to opportunistically offer self-sampling to women overdue cervical screening or usual care when they consulted their GP for any reason. Within each Practice, women were individually randomized to 3 arms (2:1:1): usual care, directly-mailed self-sample kit, or letter inviting them to order a self-sample kit (via web request or postal form). Differences in self-sampling uptake between women in different arms were evaluated using chi-squared tests (a statistical test used to compare observed results with expected results).Lay Summary of Results:
In the primary analysis, 5.6% of women in the intervention arm returned a self-sample within 6 months, compared to 1.8% in the control arm.
Of the 449 women known to have been offered a self-sample kit opportunistically, 333 (74.2%) accepted the offer, and 234 (52.1%) of these women returned a self-sample kit within 6 months.
Among women randomized to either be mailed a self-sampling kit directly or a letter inviting them to order a self-sampling kit, uptake was 2.5 times higher among women who were sent a self-sampling kit (12% vs 5%), though with only ~12% uptake among those sent a kit directly, there are high levels of wastage.
Compliance to follow up amongst self-sample HPV positive was relatively high.
We showed that the uptake of self-sampling among women was by far the highest among women who were opportunistically offered kits in primary care. Our findings suggest that an opt-in approach to non-attender self-sampling kit distribution will have limited success in the UK. However, an important caveat to this is that translated invitational materials were not provided in this study. Furthermore, relatively low numbers of kits were returned once ordered, regardless of how they were ordered by post or web. This could potentially be enhanced by reminder texts or postcards.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1655
Date of REC Opinion
14 Nov 2017
REC opinion
Favourable Opinion