A randomized, controlled trial of two strategies of offering the home‐based HPV self‐sampling test to non‐ participants in the Flemish cervical cancer screening program
Open accessAbstract
We conducted a randomized, controlled trial to evaluate different strategies of offering an HPV‐self sampling program, and compared this with two control groups. All total of 35,354 women who did not participate in the Flemish cancer screening program were included in the study: 9,118 received a HPV self‐collection brush (RIATOL qPCR HPV genotyping test (qPCR [E6/E7]); 9,098 were offered the opportunity to order an HPV‐selfsampling brush, 8,830 received the recall letter; 8,849 received no intervention. Within 12 months after the mailing, 18.7% of the women who had received the brush, participated by returning a self‐sample sample, while 10.6% women allocated to the opt‐ in group did so. 10.5% women who received the standard recall letter, had a PAP smear taken within a period of 12 months; while 8% women did so without receiving an intervention at all. Participation in postmenopausal women was higher than in women younger than 50 in both self‐sampling arms. Screening by means of the self‐sample kit increased by age, contradictory when screening is performed by a PAP smear. Of those testing hrHPV positive (9.5%), 88.9% attended for follow up cytology. The mean DNA concentration, found in the self‐sampler, decreased by age, causing a higher number of inconclusive results. Our results support the efficacy of a self‐sampling strategy to increase participation in the Flemish screening program. Self‐sampling seems particularly acceptable to postmenopausal non‐responders. Future research should focus on the performance of different self‐sampling devices in post‐menopausal women as low DNA concentrations exponentially increased over age.
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In the Belgian randomized clinical trial, the response rate was 8.0% (95% CI 7.5% to 8.6%) in the control arm with no letter.
“whereas in the second control arm (no letter), the response rate was slightly lower (8.0%, 95% confidence interval 7.5% to 8.6%)”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [69]
The Participation section reports that 709 women (8%) in the no-intervention arm had a PAP smear within 12 months, and the study description identifies this as the second control group. Our copy does not report the claimed 95% confidence interval of 7.5%–8.6% for that rate; the Statistical analysis section discusses confidence intervals for odds ratios instead. Page numbers are not available for these passages. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the Belgian randomized clinical trial, the response rate was 10.5% (95% CI 9.9% to 11.2%) in the control arm with a reminder letter.
“In the first control arm (reminder letter) the response rate was 10.5% (95% confidence interval 9.9% to 11.2%)”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [69]
The Participation section reports that 931 of 8,830 women (10.5%) in the recall-letter control group had a Pap smear within 12 months. Our copy does not report the claimed 95% confidence interval of 9.9% to 11.2%, although it is consistent with the reported counts. (LLM, conf=0.82)
Experimental — accuracy not yet measured
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- Authors
- Kellen, E., Benoy, I., Vanden Broeck, D., Martens, P., Bogers, J., Haelens, A., & Van Limbergen, E.
- Affiliations
- Universitair Ziekenhuis Leuven (BE)
- University of Antwerp (BE)
- AML, Sonic Healthcare Antwerp Belgium
- Centre for Cancer Detection Flanders Belgium
- Belgian Cancer Registry, Saint‐Josse‐ten‐Noode Belgium
- Corresponding author
- Kellen, Eliane
- Venue
- International Journal of Cancer
- Publisher
- Wiley
- Published
- 2018-04-10
- Volume
- 143
- Issue
- 4
- Pages
- 861-868
- ISSN
- 0020-7136 (ISSN-L)
- 1097-0215
- OpenAlex
- W2832434163
- Semantic Scholar
- 2ea7be3f98cc96de9e9405c2d4791dd2819377b4
- Cited by
- 48
- References
- 27
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 8 · 2023: 3 · 2022: 14 · 2021: 5 · 2020: 4 · 2019: 5 · 2018: 2
- FWCI
- 3.12
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- International Journal of Cancer (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Flemish Government
- 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
- HPV self-sampling, cervical cancer screening, screening uptake, non-participants, postmenopausal women, high-risk HPV, indeterminate results, DNA concentration
- MeSH terms
- Age Factors, Belgium, Uterine Cervical Neoplasms, DNA, Viral, Female, Humans, Mass Screening, Middle Aged, Patient Acceptance of Health Care, Self Care, Vaginal Smears, Papillomavirus Infections, Alphapapillomavirus, Early Detection of Cancer
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