Research and analysis

HPValidate study summary

Published 8 November 2024

HPValidate was set up as a first step to find out if vaginal self-taken samples are as accurate at identifying human papillomavirus (HPV) as standard clinician-taken screening tests in the NHS Cervical Screening Programme in England. The study found that 4 combinations of self-collection device and HPV tests worked well, and can: 

• inform the choice of self-sampling kits and testing platforms to use if self-sampling is offered to ‘under-screened’ people (who have never or rarely attended cervical screening)  

• be evaluated further in future scientific studies to help determine if self-sampling could be introduced effectively as a future option to all screening participants 

The ‘under-screened’ group is at a higher risk of HPV infection and associated disease. This group has the greatest need for access to acceptable and innovative screening approaches. 

A sub-study of HPValidate assessed individuals’ experience of doing HPV self-sampling and their attitudes towards using self-sampling in the future.  

It found that the experience of people completing a self-sample in a primary care setting was overwhelmingly positive. All 3 devices used in HPValidate could be considered for future use from an acceptability perspective. 

The HPValidate findings contribute to the widening evidence on the use of HPV self-sampling in cervical screening.  

Background 

The NHS Cervical Screening Programme (CSP) helps prevent cancer by checking for high-risk HPV, which can lead to cervical abnormalities and causes nearly all cervical cancers. Screening saves thousands of lives every year. 

Most screening is done in GP surgeries. A clinician (usually a nurse) takes a sample of cells from the cervix, and this is sent to a laboratory to check for high-risk HPV. If high-risk HPV is found, the laboratory then tests the cervical sample for abnormal cells. People who receive an abnormal screening result from this test are often referred for a colposcopy. A colposcopy is a visual examination of the cervix to help confirm if abnormal cells are present that need to be removed.  

In England, cervical screening currently prevents around 70% of cervical cancer deaths, but approximately 3 in 10 people do not take up the offer of screening. It could prevent many more deaths if everyone invited was able to attend screening regularly. 

It is important to try to remove barriers to screening engagement where possible. One option could be for people to take their own sample for HPV testing, rather than a clinician take their sample.  

Vaginal HPV self-sampling involves a person using a swab or brush to collect a sample from the vagina. This is different to a clinician taking a sample of cells from the cervix using a brush. A vaginal self-sample can only replace the first screening test and is used for HPV testing, not to check for abnormal cells. If a person tests positive for high-risk HPV on a vaginal self-sample, they will need to go to a healthcare facility to have a clinician-taken cervical sample to check for abnormal cells. 

In 2019, the UK National Screening Committee (UK NSC) recommended that more evidence should be collected on the potential of HPV self-sampling to improve engagement with the NHS CSP. 

The HPValidate study was set up in England as a first step to find out if vaginal self-sampling for HPV could be offered as an alternative option alongside clinician-taken sampling.  

The study was commissioned and funded by Public Health England, which hosted the UK NSC until 2021. The study ran in the NHS England CSP from 2021 to December 2023.

The 3 main aims of the study were to: 

• collect evidence on the accuracy of vaginal self-sampling compared to clinician-collected cervical sampling for HPV testing within the UK population. This was done using:
  • 3 different collection devices: Evalyn Brush (Rovers Medical), Self-Vaginal Floqswabs (Copan) and Aptima Multitest (Hologic)
  • the 2 HPV tests used by laboratories in the UK for testing cervical screening samples at the time: the Cobas HPV Test (Roche) and the Aptima HPV Assay (Hologic) 

• assess the practicality of testing self-samples in HPV laboratories in England 

• assess user experience of the 3 different self-sampling devices among people using them in primary care settings and explore their views on self-sampling in the future  

Results 

Clinical validation 

The study recruited more than 6,000 eligible people from GP practices and colposcopy clinics. People who participated in HPValidate were invited to take a self-sample, using a vaginal swab or brush. Those recruited in GP practices also had their standard clinician sample taken when they attended their routine appointment.  

The laboratories tested both samples (self-taken and clinician-taken) so the results could be compared. 

The following self-collection device and test combinations worked well:  

• Evalyn Brush and Cobas  

• FLOQswabs and Cobas  

• FLOQswabs and Aptima

• Aptima Multitest and Aptima

The methods and findings from HPValidate could inform the choice of self-sampling kits and testing platforms to use if self-sampling is offered to ‘under-screened’ people who have never or rarely attended cervical screening. This group is at a higher risk of HPV infection and associated disease. 

The results could also be used in further scientific evaluations to help determine if self-sampling could be introduced effectively as a future option for all screening participants. 

The study assessed the practicality of testing HPV self-samples in 5 HPV laboratories in England. Its assessment was generally positive and a number of recommendations can be found in the full report. 

See the full clinical validation report published by Queen Mary University of London. 

User acceptability 

People taking part in HPValidate who completed their self-sample at a GP surgery were asked to complete a short questionnaire and 2,320 individuals (48% of the participants) did so. 

The user acceptability questionnaire aimed to:  

• assess people’s experiences of doing self-sampling at their GP surgery, including how easy they found it 

• look for any differences in experience between using each of the 3 self-sampling collection devices  

• look for any differences in experience depending on factors such as age and previous screening experience 

• find out if people would prefer self-sampling or testing by a clinician in future 

• find out what people thought about being offered a choice between self-sampling and clinician-taken tests 

Most participants said the overall experience of using a self-sample was excellent (75%) or good (23%).  

Very few participants experienced ‘a lot’ or ‘severe’ discomfort (1%) or found it a ‘moderately’ or ‘very’ unpleasant experience (2%).  

If offered a choice, 69% said they would choose self-sampling while 19% would prefer to have the test done by a clinician. 

Most participants (85%) said they would like to be given a choice between self-sampling and clinician screening, but 23% felt it would be difficult to choose and 15% would worry about making a choice. Nearly half (48%) of the respondents would prefer to receive a recommendation of which method to use.  

If implementing self-sampling in the cervical screening programme, it would be important to take the user acceptability findings into account to ensure choices do not cause anxiety or increase social inequalities to screening access. 

The study highlighted the need to evaluate different methods of offering this choice to understand how best to support people to make an informed decision. 

See the full user acceptability report published by Queen Mary University of London.

Core reporting group and other contributors

Details of the core reporting group and other contributors to the study are available in the full clinical validation report published by Queen Mary University of London. 

Academic publications 

Marlow L, Drysdale H, Waller J. Attitudes towards being offered a choice of self-sampling or clinician sampling for cervical screening: A cross-sectional survey of women taking part in a clinical validation of HPV self-collection devices. J Med Screen. 2024 Oct 9:9691413241283356. doi: 10.1177/09691413241283356. Epub ahead of print. PMID: 39383889.