Acceptability of HPV-self Sampling

NCT ID: NCT03137563

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2019-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.

The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.

These questionnaires will be collected and statistical analysis will be performed using appropriate tools.

This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.

These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Women 25-65 years

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

questionnaire

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Distribution of an anonymous questionnaire

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Virgins
* Previous hysterectomy
* Present or previous cervical pathology
* Patient under guardianship or tutorship
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dépistages34 (Montpellier - France)

UNKNOWN

Sponsor Role collaborator

Adoc11 (Carcassonne - France)

UNKNOWN

Sponsor Role collaborator

Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nathalie BOULLE, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 33106125 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UF9839

Identifier Type: -

Identifier Source: org_study_id