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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

- 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.

Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;

Recent immigrants, documented or undocumented;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • HPV self sampling

    Other intervention

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

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: prospective cervical cancer screening interventionOther 1 intervention

Trial outcomes

Primary outcomes

1

Total number and proportion of eligible women (age 30 to 65, unscreened for cervical cancer for 3 to 5 years) who had an HPV PCR test on a self-collected vaginal sample when offered in a nonclinical setting by the Bus Santé de Seine-Saint-Denis

Time frame
Day 0

Secondary outcomes

1

Declined to participate: number and why

Time frame
Day 0
2

Description of the barriers to cervical cancer screening in the target population

Time frame
Day 0
3

Proportion of complete HPV-HR PCRs run onboard the Bus and proportion with same-day results available to the participants

Time frame
Day 0
4

Frequency of positive HPV-HR tests and of invalid HPV-HR tests using SCVS samples

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Hospital Avicenne

Collaborator

National Cancer Institute, France

Collaborator

INSERM UMR S 1136

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

This trial is not recruiting at the moment. You can still explore other options: