NCT03137563

Brief Summary

This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling. These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

April 28, 2017

Last Update Submit

December 29, 2020

Conditions

Keywords

Women25-65 years

Outcome Measures

Primary Outcomes (1)

  • accept HPV self-sampling for cervical cancer

    Response " Yes " or " No " to the question " would you accept HPV self-sampling for cervical cancer screening ?

    1 day

Secondary Outcomes (1)

  • Socioeconomic determinants of the response

    1 day

Study Arms (1)

Women eligible for cervical cancer screening

French women aged 25 to 65 years living in the Department of Hérault or Aude (France), attending one of the 8 centers where the questionnaire will be distributed

Other: questionnaire

Interventions

The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.

Also known as: Distribution of an anonymous questionnaire
Women eligible for cervical cancer screening

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women attending 8 centers of the Departments of Hearault and Aude : social medical cares, Department of gynecology in the hospitals of Montpellier and Carcassonne ; mid-wifes consultations.

You may qualify if:

  • Women 25-65 years old
  • Living in the Aude or Herault departments

You may not qualify if:

  • Virgins
  • Previous hysterectomy
  • Present or previous cervical pathology
  • Patient under guardianship or tutorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daures JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health. 2021 Jan;61(1):83-94. doi: 10.1080/03630242.2020.1831683. Epub 2020 Oct 26.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nathalie BOULLE, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 2, 2017

Study Start

May 15, 2017

Primary Completion

July 30, 2017

Study Completion

July 30, 2019

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations