Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-07-30

Brief Summary

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The study is a prospective cervical cancer screening intervention in the nonclinical setting of a mobile testing unit in a vehicle, using point-of-care HPV PCR tests with self-collected vaginal swabs.

It is designed for women with limited access to healthcare and prevention in underprivileged municipalities in the greater Paris area (Seine-Saint-Denis department, detailed in Annexe 3).

HPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs

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Detailed Description

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Conditions

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Women's Health: Cervical Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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prospective cervical cancer screening intervention

Evaluation of a cervical cancer screening outreach intervention using point-of-care High-Risk HPV (HPV-HR) tests on self-collected vaginal swabs

Group Type OTHER

HPV self sampling

Intervention Type OTHER

Selected women will perform a vaginal self-sampling using a swab

Interventions

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HPV self sampling

Selected women will perform a vaginal self-sampling using a swab

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- Women from 30 to 65 years of age presenting to the " Bus Santé " nonclinical testing unit, eligible to cervical cancer screening by an HPV-HR test
* Women affiliated to the French social security or immigrants benefiting from the state medical aid program for undocumented immigrants (Aide Médicale d'Etat). The inclusion of people not affiliated to a social security system is an exception and depends on the decision of the Personal Protection Committee, if it is based on an expected benefit for these people of a nature to justify the foreseeable risk incurred.
* The intervention is designed for vulnerable women with limited access to healthcare, including but not limited to:

* Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;
* Recent immigrants, documented or undocumented;
* Young adults from priority neighbourhoods,
* Isolated or marginalized women
* Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any sampling carried out as part of the trial (article L1122-1-1 of the Public Health Code)

The Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.

Exclusion Criteria

* Screened for cervical cancer by a PAP smear in the last 3 years or by an HPV test in the last 5 years,
* Women on their period (haemoglobin inhibits PCRs)
* Pregnancy in the 2nd and 3rd trimesters
* Total hysterectomy; absence of a vagina
* Women under guardianship/tutelage

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes