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)

NCT06656611 | Not Yet Recruiting DMC

• 1 other identifier: IMEA 072
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Women's Health: Cervical Neoplasm

Keywords

HPV; cervical cancer; outreach intervention; vaginal self sampling

Outcome Measures

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

  Day 0

Secondary Outcomes (15)

• Declined to participate: number and why

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

• Description of HPV types in the participant population

  Day 0

Study Arms (1)

prospective cervical cancer screening intervention

OTHER

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

Interventions

HPV self sampling OTHER

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

prospective cervical cancer screening intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• 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
• The Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hopital Avicenne

Bobigny, 93000, France

Location

Related Publications (6)

• Rahib D. Place de l'auto-prélèvement " à domicile " dans les stratégies de dépistage du VIH et des autres infections sexuellement transmissibles chez les hommes ayant des relations sexuelles avec des hommes en France. 2022; Available at: https://theses.fr/api/v1/document/2022SORUS219

  BACKGROUND

• Reques L, Rolland C, Lallemand A, Lahmidi N, Aranda-Fernandez E, Lazzarino A, Bottero J, Hamers F, Bergeron C, Haguenoer K, Launoy G, Luhmann N. Comparison of cervical cancer screening by self-sampling papillomavirus test versus pap-smear in underprivileged women in France. BMC Womens Health. 2021 May 26;21(1):221. doi: 10.1186/s12905-021-01356-8.

  PMID: 34039341 BACKGROUND

• Pretsch PK, Spees LP, Brewer NT, Hudgens MG, Sanusi B, Rohner E, Miller E, Jackson SL, Barclay L, Carter A, Wheeler SB, Smith JS. Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial. Lancet Public Health. 2023 Jun;8(6):e411-e421. doi: 10.1016/S2468-2667(23)00076-2. Epub 2023 May 11.

  PMID: 37182529 BACKGROUND

• CNR HPV. Trousses de détection des HPV ayant bénéficié d'une validation clinique pour le dépistage du cancer du col de l'utérus. 2023; Available at: https://cnr-hpv.fr/wp-content/uploads/2023/03/Liste-des-trousses-de-detection-et-de-genotypage-des-HPV-validees-par-les-fabricants-de-milieux-v11.pdf.

  BACKGROUND

• Institut National du Cancer, CNR HPV, France. Référentiel national - Dépistage du cancer du col de l'utérus - cadre et modalités de recours aux autoprélèvements vaginaux. 2022; Available at: https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Referentiel-national-Depistage-du-cancer-du-col-de-l-uterus-cadre-et-modalites-de-recours-aux-autoprelevements-vaginaux.

  BACKGROUND

• Dourgnon P, Jusot F, Sermet C, Silva J. La santé perçue des immigrés en France. 2008; Available at: https://www.irdes.fr/Publications/Qes/Qes133.pdf.

  BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

KARINE AMAT

CONTACT

0140256352; karine.amat@fondation-imea.org

Aïda BENALYCHERIF

CONTACT

0140256365; aida.benalycherif@fondation-imea.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: October 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-08

Locations

FR (1)