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AzTrials

Women's Health: Cervical NeoplasmPAPMOBILENCT06656611

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)

A study testing HPV self sampling in people with Women's Health: Cervical Neoplasm, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Women's Health: Cervical Neoplasm
What is being tested?
HPV self sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteFrance
Study dates
1 Dec 2024to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - 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,
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

KARINE AMAT contact

0140256352

karine.amat@fondation-imea.org

Aïda BENALYCHERIF contact

0140256365

aida.benalycherif@fondation-imea.org

France1 site

  • Hopital Avicenne

    Bobigny, 93000

Other trials in France

About this study

Official 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)

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

Being tested
HPV self sampling
Keywords
HPV, cervical cancer, outreach intervention, vaginal self sampling
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV self samplingOther

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

Study groups in NCT06656611
Study groupRoleWhat they receive
prospective cervical cancer screening interventionOtherEvaluation of a cervical cancer screening outreach intervention using point-of-care High-Risk HPV (HPV-HR) tests on self-collected vaginal swabs
Receives: Other: HPV self sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 0

Secondary outcomes (15)

  1. Declined to participate: number and why

    Measured: Day 0

  2. Description of the barriers to cervical cancer screening in the target population

    Measured: Day 0

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

    Measured: Day 0

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

    Measured: Day 0

  5. Description of HPV types in the participant population

    Measured: Day 0

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

    Measured: 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)

    Measured: Day 0

  8. Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs

    Measured: 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)

    Measured: Day 0

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

    Measured: 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…)

    Measured: Day 0

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

    Measured: Day 0

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

    Measured: Day 0

  14. Staff satisfaction by self-questionnary

    Measured: Day 0

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656611
Sponsor's protocol ID
IMEA 072
Acronym
PAPMOBILE
Status last verified
Aug 2024
First submitted
25 Jul 2024
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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

  • 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.

    PubMed 34039341

  • 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.

    PubMed 37182529

  • 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.

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing HPV self sampling in people with Women's Health: Cervical Neoplasm, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact KARINE AMAT (0140256352, karine.amat@fondation-imea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656611, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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