A randomized controlled trial in non-responders from Newcastle upon Tyne invited to return a self-sample for Human Papillomavirus testing versus repeat invitation for cervical screening
Abstract
BACKGROUND: Non-attenders for cervical screening are at increased risk of cervical cancer. Studies offering self-sampling for high-risk Human Papillomavirus (HrHPV) testing have shown greater uptake than sending another invitation for cytology. OBJECTIVES: To explore whether uptake would increase in a less diverse, more stable population than the previous English study, which demonstrated a lower response rate than other studies. The primary objective was whether non-attenders were more likely to respond to a postal invitation, including kit, to collect a self-sample compared with a further invitation for cytology screening. The secondary objective was whether women with an abnormal result would attend for follow-up. METHODS: 6000 non-attenders for screening in this pragmatic, randomized (1:1) controlled trial in Newcastle-upon-Tyne were sent an HPV self-sample kit (intervention) or a further invitation for cytology screening (comparator). RESULTS: 411(13%) responded to the intervention, returning a self-sample (247(8%)) or attending for cytology (164(5%)), compared with 183(6%) attending for cytology, relative risk 2.25 (95% CI 1.90-2.65) (comparator arm). Of those testing hrHPV positive (32(13%)), 19(59%) subsequently attended cytology screening. Of those in the intervention group who attended for cytology screening without returning an hrHPV self-sample (n = 164), 5% (n = 8) were referred for colposcopy - all attended. In the comparator group eight of the nine referred for colposcopy attended. CONCLUSION: Persistent non-responders to invitations for cervical screening are significantly more likely to respond to a postal invitation to return a self-collected sample for HPV testing than a further invitation for cytology screening. However, just over half followed up on this positive HPV result.
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Three (12%) of the 25 trials met the criteria for low risk of bias in all categories.
“Three (12%) of the 25 trials met the criteria for low risk of bias in all categories.114 115 117”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [114]
The Design (p. 2) identifies this source as a randomized trial, and Randomization and blinding (p. 4) describes its allocation and blinding procedures. The paper does not assess 25 trials or establish that three met low-risk-of-bias criteria in every category; it supports identifying one trial, not the aggregate claim. (LLM, conf=0.82)
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- Authors
- Cadman, L., Wilkes, S., Mansour, D., Austin, J., Ashdown-Barr, L., Edwards, R., Kleeman, M., & Szarewski, A.
- Affiliations
- Queen Mary University of London (GB)
- University of Sunderland (GB)
- Newcastle Hospitals, Community Health, New Croft Centre, Market Street (East), Newcastle upon Tyne, NE1 6ND
- Corresponding author
- Wilkes, Scott
- Venue
- Journal of Medical Screening
- Publisher
- SAGE Publications
- Published
- 2014-11-17
- Volume
- 22
- Issue
- 1
- Pages
- 28-37
- ISSN
- 0969-1413 (ISSN-L)
- 1475-5793
- OpenAlex
- W2004590309
- Cited by
- 58
- References
- 41
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 5 · 2023: 2 · 2022: 14 · 2021: 4 · 2020: 2 · 2019: 3 · 2018: 7 · 2017: 5 · 2016: 3 · 2015: 2
- FWCI
- 2.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Medical Screening (publishedVersion)
- PubMed (publishedVersion)
- Sunderland Repository (University of Sunderland) (acceptedVersion)
- Funders
- Cancer Research UK (C8162/A10406, C569/A10404)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
- Keywords
- cervical cancer screening, HPV self-sampling, high-risk HPV testing, cytology screening, follow-up attendance, colposcopy referral, Newcastle upon Tyne
- MeSH terms
- Adult, Aged, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, England, Female, Humans, Mass Screening, Middle Aged, Patient Compliance, Specimen Handling, Vaginal Smears, Papillomavirus Infections, Alphapapillomavirus
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