Women's Health: Cervical Neoplasm
Conditions
Keywords
HPV, cervical cancer, outreach intervention, vaginal self sampling
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
Interventions
OTHERHPV self sampling
Selected women will perform a vaginal self-sampling using a swab
Sponsors
Hospital Avicenne
National Cancer Institute, France
INSERM UMR S 1136
Institut National de la Santé Et de la Recherche Médicale, France
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Declined to participate: number and why | 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) |
| 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 |
Countries
France
Contacts
Primary ContactKARINE AMAT
Backup ContactAïda BENALYCHERIF
Outcome results
None listed