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Self-sampling for HPV Screening

NCT07273383 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-12-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

HPV self-sampling test

HPV self-sampling test

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-31
Completion
2026-02-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273383 on ClinicalTrials.gov