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NCT Number: NCT06656611

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV self sampling

Other

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

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

  5. Description of HPV types in the participant population

    Time frame: Day 0

  6. Comparison of HPV-HR negative and HPV-HR positive participants

    Time frame: Day 0

  7. 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

  8. Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs

    Time frame: Day 0

  9. 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

  10. Proportion of valid self-collected vaginal swabs (cellular density, valid HPV PCR)

    Time frame: Day 0

  11. 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

  12. Reliability of vaginal self-sampling in a nonclinical setting: proportion of valid samples, types of non-conformity

    Time frame: Day 0

  13. Participant satisfaction with point-of-care self-sampling and HPV testing; proportion willing to recommend the intervention to their acquaintance

    Time frame: Day 0

  14. Staff satisfaction by self-questionnary

    Time frame: Day 0

  15. Adverse events; setbacks and adjustments over the study period

    Time frame: From day 0 to the last call (about month 2)

Study contacts

Contact information is provided by the study sponsor or research team.

Aïda BENALYCHERIF

CONTACT

[email protected]

0140256365

KARINE AMAT

CONTACT

[email protected]

0140256352

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Hospital Avicenne
  • INSERM UMR S 1136
  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Cancer Institute, France

Registry information

Official study title

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)

Acronym: PAPMOBILE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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