NCT05414929

Brief 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. 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.).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

March 10, 2022

Last Update Submit

June 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the acceptability of HPV self-sampling by patients

    percentage of patients who prefer HPV testing to traditional cytology

    2 months following recruitment

Secondary Outcomes (3)

  • Evaluate the percentage of samples collected correctly by patients

    2 months following recruitment

  • Evaluate the return rate of mailed kits

    2 months following recruitment

  • Calculate the HPV positivity rate in a population sample

    2 months following recruitment

Study Arms (1)

HPV self-sampling group

EXPERIMENTAL
Diagnostic Test: HPV self-sampling

Interventions

HPV self-samplingDIAGNOSTIC_TEST

HPV self-sampling (Cobas Uniswab)

HPV self-sampling group

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speak and understand French without help
  • Have internet access (for completing forms)
  • Have a mailing address

You may not qualify if:

  • Known positive HPV status • Have already had a hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, j1n4j6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

June 10, 2022

Study Start

April 4, 2022

Primary Completion

May 15, 2022

Study Completion

June 30, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations