To hear about similar clinical trials, please enter your email below
Trial Title:
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)
NCT ID:
NCT06656611
Condition:
Women's Health: Cervical Neoplasm
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
HPV
cervical cancer
outreach intervention
vaginal self sampling
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
HPV self sampling
Description:
Selected women will perform a vaginal self-sampling using a swab
Arm group label:
prospective cervical cancer screening intervention
Summary:
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
Criteria for 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
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hopital Avicenne
Address:
City:
Bobigny
Zip:
93000
Country:
France
Start date:
December 1, 2024
Completion date:
July 30, 2026
Lead sponsor:
Agency:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Agency class:
Other
Collaborator:
Agency:
Hospital Avicenne
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Collaborator:
Agency:
IPLESP INSERM U1136
Agency class:
Other
Collaborator:
Agency:
IAME INSERM U1137
Agency class:
Other
Source:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656611
