HPVHPVselftestNCT07273383
Self-sampling for HPV Screening
A study testing HPV self-sampling test in people with HPV and Cervical Cancers, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Cervical Cancers
- What is being tested?
- HPV self-sampling test
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known positive HPV status
- History of total hysterectomy
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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:
- HPV 16 or 18 positive: Patients will be referred for colposcopy.
- Positive for HPV other than 16 or 18:Patients will be referred to a nurse-led colposcopy clinic for cervical cytology.
- HPV negative:Patients will be encouraged to follow Québec's cervical cancer screening recommendations.
- 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.
Read the 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,
- Conditions
- HPV, Cervical Cancers
- Being tested
- HPV self-sampling test
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-sampling testDiagnostic test
HPV self-sampling test
| Study group | Role | What they receive |
|---|---|---|
| Experimental | One group will receive and return their self-sampling kit by mail. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: HPV self-sampling test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after the self-collection kits have been sent
Return rate
Evaluate the return rate of the kits based on the collection method.
Measured: 6 weeks after the self-collection kits have been sent
Secondary outcomes (2)
HPV positivity rate
Number of patients HPV positive according to different cervical cancer risk factors (smoking, hpv vaccination status)
Measured: 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
Measured: 6 weeks after the self-collection kits have been sent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ruel Laliberté, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273383
- Sponsor's protocol ID
- 2025-5842
- Acronym
- HPVselftest
- Status last verified
- Nov 2025
- First submitted
- 22 May 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-sampling for HPV Screening: a Population-based Feasibility Study
- ClinicalTrials.gov ID
- NCT07273383
- Acronym / sponsor ID
- HPVselftest / 2025-5842
- Conditions
- HPV, Cervical Cancers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- HPV 16 or 18 positive: Patients will be referred for colposcopy.
- Positive for HPV other than 16 or 18:Patients will be referred to a nurse-led colposcopy clinic for cervical cytology.
- HPV negative:Patients will be encouraged to follow Québec's cervical cancer screening recommendations.
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental | Diagnostic Test: HPV self-sampling testOne group will receive and return their self-sampling kit by mail. | |
| Community pharmacy | Experimental | Diagnostic Test: HPV self-sampling testA second group will pick up their kit from a community pharmacy and return it by mail. |
| Family planning clinic | Experimental | Diagnostic Test: HPV self-sampling testA 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. |
| Vaccination center | Experimental | Diagnostic Test: HPV self-sampling testFinally, 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Known positive HPV status
- History of total hysterectomy
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV self-sampling testHPV self-sampling test | Diagnostic test | Community pharmacy, Family planning clinic, Mail, Vaccination center |
Primary outcome
Assess the percentage of samples correctly collected by patients (considered compliant) according to the collection method.
Time frame: 6 weeks after the self-collection kits have been sent
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.
Return rate
Time frame: 6 weeks after the self-collection kits have been sent
Evaluate the return rate of the kits based on the collection method.
2 secondary outcomes
HPV positivity rate
Time frame: 6 weeks after the self-collection kits have been sent
Patient satisfaction
Time frame: 6 weeks after the self-collection kits have been sent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self-sampling test in people with HPV and Cervical Cancers, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the percentage of samples correctly collected by patients (considered compliant) according to the collection method. (time frame: 6 weeks after the self-collection kits have been sent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.