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| Name | Class |
|---|---|
| Hospital Avicenne | OTHER |
| National Cancer Institute, France | OTHER_GOV |
| INSERM UMR S 1136 | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV self sampling | Other | Selected women will perform a vaginal self-sampling using a swab |
|
| Measure | Description | 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 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KARINE AMAT | Contact | 0140256352 | karine.amat@fondation-imea.org | |
| Aïda BENALYCHERIF | Contact | 0140256365 | aida.benalycherif@fondation-imea.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Avicenne | Bobigny | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 34039341 | 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. | |
| 37182529 |
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| OTHER_GOV |
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| 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 |
| Comparison of HPV-HR negative and HPV-HR positive participants | 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) | Day 0 |
| Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs | 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) | Day 0 |
| Proportion of valid self-collected vaginal swabs (cellular density, valid HPV PCR) | 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…) | Day 0 |
| Reliability of vaginal self-sampling in a nonclinical setting: proportion of valid samples, types of non-conformity | Day 0 |
| Participant satisfaction with point-of-care self-sampling and HPV testing; proportion willing to recommend the intervention to their acquaintance | Day 0 |
| Staff satisfaction by self-questionnary | Day 0 |
| Adverse events; setbacks and adjustments over the study period | From day 0 to the last call (about month 2) |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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