HPV self-sampling as an alternative strategy in non-attenders for cervical screening – a randomised controlled trial

Abstract

Background:A randomised trial to ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to a further invitation to attend for cervical screening.Methods:The study was carried out in a Primary Care Trust (PCT) in London between June 2009 and December 2009. In total, 3000 women were randomly selected from persistent non-responders (i.e., who had not responded to at least two invitations to attend for screening). The women were randomised on a 1 : 1 basis to either receive an HPV self-sampling kit or a further invitation to attend for cervical cytology. The main outcome measures were (1) percentage of women attending for cervical cytology compared with those returning a self-sample HPV test or attending for cytology subsequent to receiving the kit and (2) percentage of those testing positive for HPV who attended further investigation.Results:The total response in the self-sampling group for screening was 10.2%. Of the 1500 women in the control group sent a further invitation for cervical screening, 4.5% attended for cytology screening. This difference is highly statistically significant (P<0.0001). Of the 8 women who tested positive for HPV, 7 attended for a cervical smear and had a concurrent colposcopy. Three of these (43%) had high-grade disease (defined as CIN 2+), with one found to have an invasive cancer (stage 1b) and one CIN 3.Conclusions:The value of this intervention relies on the detection of high-grade CIN and early stage cancer with a good prognosis. The relatively high yield of abnormalities found is consistent with that expected among a hard to reach and relatively high-risk group of women. Our study suggests that self-sampling could increase participation among non-responders in England, but further work is needed to ascertain whether the low response rate seen here is likely to be representative of the rest of the country. Other studies are needed to investigate the response to self-sampling in different demographic and geographic settings.

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

“…Dislike of a gynaecological examination could be overcome by self-sampling, which had been shown to be a feasible and reliable means of testing for high-risk HPV. 8,9 Again, the inconvenience of having to book could be addressed by self-testing and by timed appointments, which have been used effectively for other purposes in some general practices. The potential fear of what is involved and a poor understanding of the rationale and potential benefits and harms of cervical screening could be addressed by use of a nurse navigator (NN), a term coined in the USA, where this role has been evaluated in a number of areas of health.…”

Human papillomavirus self-sampling for screening nonattenders: Opt-in pilot implementation with electronic communication platforms

“…In previous studies from screening programs with high screening coverage rates, such as the Netherlands and various Scandinavian countries, all nonattenders were mailed self‐sampling kits (“opt‐out” approach) 6, 7, 8, 9. This strategy, where 6–34% of nonattenders returned their self‐sampling kits for analysis,6, 10 leads to considerable waste of the distributed, but unused kits. An alternative approach is to have nonattenders actively “opt in,” that is, order the self‐sampling kits if interested after receiving an invitation from the screening program.…”

Dry self-sampling versus provider-sampling of cervicovaginal specimens for human papillomavirus detection in the Inuit population of Nunavik, Quebec

“…Additionally, self-sampling has the potential to increase the number of women screened for cervical cancer by increasing the participation of screening non-responders. 13,14 As selfsampling is a less invasive method, it may be appealing to women who fear speculum examination conducted by a health provider because of previous abuse, 15 feelings of embarrassment, 16 perceived inconvenience, 17 and cultural and religious reasons. 18,19 The Quebec Inuit population, who have a higher cervical cancer incidence and mortality rate than the general population of Quebec, 20 could benefit from a screening programme that incorporates HPV testing of self-collected samples.…”