Self-sampling for HPV Screening

NCT07273383 | Active Not Recruiting

• 1 other identifier: 2025-5842
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

HPV; Cervical Cancers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• HPV positivity rate

  6 weeks after the self-collection kits have been sent

• Patient satisfaction

  6 weeks after the self-collection kits have been sent

Study Arms (4)

Mail

EXPERIMENTAL

One group will receive and return their self-sampling kit by mail.

Diagnostic Test: HPV self-sampling test

Community pharmacy

EXPERIMENTAL

A second group will pick up their kit from a community pharmacy and return it by mail.

Diagnostic Test: HPV self-sampling test

Family planning clinic

EXPERIMENTAL

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

Vaccination center

EXPERIMENTAL

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

Interventions

HPV self-sampling test DIAGNOSTIC_TEST

HPV self-sampling test

Community pharmacy; Family planning clinic; Mail; Vaccination center

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CHUS

Sherbrooke, Quebec, J1H5N3, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Msc

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: December 9, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)