NCT07273383: HPVselftest

Self-sampling for HPV Screening

Active, enrolled NA Last updated 9 December 2025

What this trial tests

NA trial testing HPV self-sampling test in HPV in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2025

Primary endpoint
31 December 2025

1 February 2026

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,000
Start date	1 June 2025
Primary completion	31 December 2025
Estimated completion	1 February 2026
Sites	1 location across Canada

Drugs / interventions tested

• HPV self-sampling test

Conditions studied

• HPV — all drugs for HPV →
• Cervical Cancers — all drugs for Cervical Cancers →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

Adults 25 to 65, female only, with HPV or Cervical Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.