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) (PAPMOBILE)

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Status

Not yet enrolling

Conditions

Women's Health: Cervical Neoplasm

Treatments

Other: HPV self sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT06656611

IMEA 072

Details and patient eligibility

About

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

Enrollment

700 estimated patients

Sex

Female

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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