Self-sampling for HPV Screening (HPVselftest)

Self-sampling for HPV Screening: a Population-based Feasibility Study

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:

1. HPV 16 or 18 positive: Patients will be referred for colposcopy.
2. Positive for HPV other than 16 or 18:Patients will be referred to a nurse-led colposcopy clinic for cervical cytology.
3. HPV negative:Patients will be encouraged to follow Québec's cervical cancer screening recommendations.
4. Inconclusive result: Patients will be advised of the need to repeat cervical cancer screening.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HPV; Cervical Cancers
• Intervention / Treatment: Diagnostic test: HPV self-sampling test

Detailed Description

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,

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N3
      • CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Woman aged 25 to 65 years
• Speak and understand French without assistance
• Have a CHUS medical record number
• Have internet access (for completing the forms)
• Have a valid mailing address, email address, and phone number

Exclusion Criteria:

• Known positive HPV status
• History of total hysterectomy
• Inability to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mail; One group will receive and return their self-sampling kit by mail.	Diagnostic test: HPV self-sampling test; HPV self-sampling test
Experimental: Community pharmacy; A second group will pick up their kit from a community pharmacy and return it by mail.	Diagnostic test: HPV self-sampling test; HPV self-sampling test
Experimental: Family planning clinic; 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; HPV self-sampling test
Experimental: Vaccination center; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks after the self-collection kits have been sent
Return rate	Evaluate the return rate of the kits based on the collection method.	6 weeks after the self-collection kits have been sent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV positivity rate	Number of patients HPV positive according to different cervical cancer risk factors (smoking, hpv vaccination status)	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	6 weeks after the self-collection kits have been sent

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2025-5842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No