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)

October 23, 2024 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

PAPMOBILE: 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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bobigny, France, 93000
        • Hôpital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: HPV self sampling
Selected women will perform a vaginal self-sampling using a swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Declined to participate: number and why
Time Frame: Day 0
Day 0
Description of the barriers to cervical cancer screening in the target population
Time Frame: Day 0
Day 0
Proportion of complete HPV-HR PCRs run onboard the Bus and proportion with same-day results available to the participants
Time Frame: Day 0
Day 0
Frequency of positive HPV-HR tests and of invalid HPV-HR tests using SCVS samples
Time Frame: Day 0
Day 0
Description of HPV types in the participant population
Time Frame: Day 0
Day 0
Comparison of HPV-HR negative and HPV-HR positive participants
Time Frame: Day 0
Day 0
Proportion of secondary pelvic examination and cervical PAP smears in HPV-positive participants ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)
Time Frame: Day 0
Day 0
Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs
Time Frame: Day 0
Day 0
Number and frequency of cytological abnormalities and cervical lesions in participants who had a PAP smear following a positive HPV-HR test ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)
Time Frame: Day 0
Day 0
Proportion of valid self-collected vaginal swabs (cellular density, valid HPV PCR)
Time Frame: Day 0
Day 0
Unavailability of point-of-care HPV-HR PCR: number of days and why (reagent shortage, instrument of power failure, environmental conditions, short-staffing…)
Time Frame: Day 0
Day 0
Reliability of vaginal self-sampling in a nonclinical setting: proportion of valid samples, types of non-conformity
Time Frame: Day 0
Day 0
Participant satisfaction with point-of-care self-sampling and HPV testing; proportion willing to recommend the intervention to their acquaintance
Time Frame: Day 0
Day 0
Staff satisfaction by self-questionnary
Time Frame: Day 0
Day 0
Adverse events; setbacks and adjustments over the study period
Time Frame: From day 0 to the last call (about month 2)
From day 0 to the last call (about month 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

National Cancer Institute, France
Hospital Avicenne
IPLESP INSERM U1136
IAME INSERM U1137

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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