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)

Launched by INSTITUT DE MÉDECINE ET D'EPIDÉMIOLOGIE APPLIQUÉE - FONDATION INTERNATIONALE LÉON M'BA · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving cervical cancer screening for women who have limited access to healthcare in the Seine-Saint-Denis area of greater Paris. The study will use a mobile testing unit, known as "Bus Santé," where women can get tested for high-risk human papillomavirus (HPV) using a simple self-collection method. The goal is to reach vulnerable women, including those living in shelters, recent immigrants, or those without stable housing, who may not have had the opportunity for regular health check-ups.

Women aged 30 to 65 who meet certain criteria, such as not having had a cervical cancer screening in the last few years and who are affiliated with French social security or certain medical aid programs, can participate. Those who test positive for HPV will receive counseling and guidance to help them access further medical care. It's important to note that this trial is not yet recruiting participants, but it aims to provide a supportive and accessible way for women in underprivileged communities to take charge of their health.

Gender

FEMALE

Eligibility criteria

• 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