An interventional study of HPV self-sampling test in HPV and Cervical Cancers, sponsored by Université de Sherbrooke. Active, not recruiting at 1 site in Canada. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Prevention
To offer large-scale HPV self-sampling in Québec, it is essential to first demonstrate the most effective pathway for patient recruitment, proper sample collection, and safe continuity of care.
Hypothesis:
The hypotheses are that HPV self-sampling is a safe and effective screening method that can be implemented in Québec, and that it is a screening method appreciated by patients, reliable, and capable of increasing access to cervical cancer screening - particularly for individuals without a family physician.
Objectives:
The primary objective of this study is to assess the feasibility of a large-scale HPV self-sampling system within the CIUSSS de l'Estrie. Secondary objectives include evaluating the percentage of properly collected samples, the return rate of kits according to the collection method, the HPV positivity rate in a sample of the population based on various risk factors, and finally, assessing patient satisfaction with the self-sampling process and the preferred collection method.
Methodology:
This cross-sectional cohort study will be conducted at the CIUSSS de l'Estrie, CHUS Fleurimont. A total of 1,000 women aged 25-65 will be recruited and divided into four groups of 250 participants each. One group will receive and return their self-sampling kit by mail. A second group will pick up their kit from a community pharmacy and return it by mail. A third group will collect their kit from a family planning clinic, perform the self-sample on-site, and it will be transported by a local courier network. Finally, a fourth group will retrieve their kit and perform the self-sample at a vaccination center in Sherbrooke, with samples then transported by a local network. The specimen will be self-collected using a Copan 552C.80 FLOQ Swab and analyzed with the Cobas HPV test on the Cobas 8800 automated system. All participants will complete a recruitment questionnaire to better characterize the study population and their risk factors. A nurse (Nancy Lapointe) will be responsible for managing the test results. Patients will receive an email 8 to 12 weeks after sending their sample, informing them of their result and the next steps to follow. Four care pathways according to the HPV test result are planned:
Anticipated Results:
HPV self-sampling is a safe, effective, and reliable screening method that can be implemented in Québec. It is expected to be appreciated by patients and increase access to screening, especially among those without a family physician.
Background:
Over the course of their lifetime, it is estimated that one in 168 women in Canada will be diagnosed with cervical cancer, and one in 478 will die from it. Human Papillomavirus (HPV) is responsible for approximately 99.7% of cervical cancers. Since the 2022 recommendation from INESSS, the Pap test as a primary screening method is being progressively replaced by the HPV test. The acceptability of this test as a primary screening method is already widely endorsed by expert societies, due to its higher sensitivity compared to traditional cytology. In Québec, HPV-based cervical cancer screening is recommended every five years. However, as autonomous self-sampling has not yet been implemented, patients must obtain a prescription, and the sample must be collected by a healthcare professional - a process identical to the administrative pathway of the Pap test. This limits access to screening for patients in remote areas, those without a family physician, those reluctant to undergo a vaginal exam, or those whose busy schedules make it difficult to consult a healthcare provider. Since January 2024, British Columbia has implemented a self-sampling system that can be performed at home. According to a study by Jones et al. (2024), within the first five months post-implementation, 25,154 patients completed a mail-in HPV test, including 4,680 individuals who had never previously been screened. More than 4,000 patients who received and returned their self-sampling HPV test did not have an assigned healthcare provider. Numerous studies on the acceptability and effectiveness of HPV testing have been conducted worldwide. However, very few large-scale feasibility studies have been carried out, and none of this type have been conducted in Québec. In short,
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
One group will receive and return their self-sampling kit by mail.
Diagnostic Test: HPV self-sampling test
A second group will pick up their kit from a community pharmacy and return it by mail.
Diagnostic Test: HPV self-sampling test
A third group will collect their kit from a family planning clinic, perform the self-sample on-site, and it will be transported by a local courier network.
Diagnostic Test: HPV self-sampling test
Finally, a fourth group will retrieve their kit and perform the self-sample at a vaccination center in Sherbrooke, with samples then transported by a local network.
Diagnostic Test: HPV self-sampling test
HPV self-sampling test
Assess the percentage of samples correctly collected by patients (considered compliant) according to the collection method.
The primary objective of the study is to assess the feasibility of a large-scale HPV self-sampling system within the CIUSSS de l'Estrie.
Time frame: 6 weeks after the self-collection kits have been sent
Return rate
Evaluate the return rate of the kits based on the collection method.
Time frame: 6 weeks after the self-collection kits have been sent
HPV positivity rate
Number of patients HPV positive according to different cervical cancer risk factors (smoking, hpv vaccination status)
Time frame: 6 weeks after the self-collection kits have been sent
Patient satisfaction
Number of participants who reported being satisfied or very satisfied with the method
Time frame: 6 weeks after the self-collection kits have been sent
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke