HPV InfectionCUTE-IPSNCT05414929
Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65
A study testing HPV self-sampling in people with HPV Infection and Cervical Cancer Screening, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical Cancer Screening
- What is being tested?
- HPV self-sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak and understand French without help
- Have internet access (for completing forms)
- Have a mailing address
Who cannot join
- Known positive HPV status • Have already had a hysterectomy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, j1n4j6
About this study
Official title: Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement
We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. The HPV risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).
- Conditions
- HPV Infection, Cervical Cancer Screening
- Being tested
- HPV self-sampling
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-samplingDiagnostic test
HPV self-sampling (Cobas Uniswab)
| Study group | Role | What they receive |
|---|---|---|
| HPV self-sampling group | Experimental | Not described Receives: Diagnostic Test: HPV self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the acceptability of HPV self-sampling by patients
percentage of patients who prefer HPV testing to traditional cytology
Measured: 2 months following recruitment
Secondary outcomes (3)
Evaluate the percentage of samples collected correctly by patients
Measured: 2 months following recruitment
Evaluate the return rate of mailed kits
Measured: 2 months following recruitment
Calculate the HPV positivity rate in a population sample
Measured: 2 months following recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start4 Apr 2022
- Primary completion15 May 2022
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josianne Pare, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414929
- Sponsor's protocol ID
- 2022-4535
- Acronym
- CUTE-IPS
- Status last verified
- Jun 2022
- First submitted
- 10 Mar 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruel-Laliberte J, Jacob-Wagner M, Bestman-Smith J, Pare J. Acceptability and Preferences of Dry HR HPV Self-Sampling Mailed Kits Among Canadian Women: A Cross-Sectional Study. J Obstet Gynaecol Can. 2023 Apr;45(4):261-266. doi: 10.1016/j.jogc.2023.02.012. Epub 2023 Mar 3.
PubMed 36870436
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement
- ClinicalTrials.gov ID
- NCT05414929
- Acronym / sponsor ID
- CUTE-IPS / 2022-4535
- Conditions
- HPV Infection, Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Jun 2022 (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.
We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. The HPV risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV self-sampling group | Experimental | Diagnostic Test: HPV self-sampling |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Speak and understand French without help
Key exclusion criteria (1 listed)
- Known positive HPV status • Have already had a hysterectomy
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-samplingHPV self-sampling (Cobas Uniswab) | Diagnostic test | HPV self-sampling group |
Primary outcome
Evaluate the acceptability of HPV self-sampling by patients
Time frame: 2 months following recruitment
percentage of patients who prefer HPV testing to traditional cytology
3 secondary outcomes
Evaluate the percentage of samples collected correctly by patients
Time frame: 2 months following recruitment
Evaluate the return rate of mailed kits
Time frame: 2 months following recruitment
Calculate the HPV positivity rate in a population sample
Time frame: 2 months following recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 36870436Ruel-Laliberte J, Jacob-Wagner M, Bestman-Smith J, Pare J. Acceptability and Preferences of Dry HR HPV Self-Sampling Mailed Kits Among Canadian Women: A Cross-Sectional Study. J Obstet Gynaecol Can. 2023 Apr;45(4):261-266. doi: 10.1016/j.jogc.2023.02.012. Epub 2023 Mar 3.
Related trials for HPV Infection
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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 in people with HPV Infection and Cervical Cancer Screening, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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?
Results are not available in the source record.
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?
Evaluate the acceptability of HPV self-sampling by patients (time frame: 2 months following recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414929, which also lists 1 linked publication.
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 10 Jun 2022.