Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
NCT ID: NCT07171658
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4500 participants
INTERVENTIONAL
2025-10-07
2027-12-31
Brief Summary
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This randomized trial will compare three arms:
1. Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
2. Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection
3. Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.
Detailed Description
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* To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design).
* To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms.
* To compare prevalence of positive primary screening and triage results between study arms.
* To compare follow-up rates for participants screened positive in both intervention arms.
* To evaluate acceptability of both screening strategies (sensitization vs. home-based).
* To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group 1: Sensitization to Cervical Cancer (CC) screening
Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
Sensitization to Cervical Cancer (CC) screening
Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
Intervention Group 2: Home-based HPV self-sampling
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
Home-based HPV self-sampling
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
Interventions
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Sensitization to Cervical Cancer (CC) screening
Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
Home-based HPV self-sampling
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
Eligibility Criteria
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Inclusion Criteria
* Aged 50 to 74 years old
* Not been screened for cervical cancer in the past three years
* Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)
Exclusion Criteria
* Hysterectomy
* Non consent to participate to the study
* Incapable of judgment or under tutelage
* Pregnancy
50 Years
74 Years
FEMALE
Yes
Sponsors
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University Hospital, Geneva
OTHER
Jessica Di Vincenzo Sormani
OTHER
Responsible Party
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Jessica Di Vincenzo Sormani
Professor assistant (tenure track)
Principal Investigators
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Jessica Di Vincenzo Sormani, PhD
Role: STUDY_DIRECTOR
Haute École de Santé de Genève (HEdS-GE)
Locations
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University Hospitals of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Patrick Petignat, MD
Role: CONTACT
Facility Contacts
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Patrick Petignat, MD
Role: primary
Other Identifiers
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32HW-0_228666
Identifier Type: -
Identifier Source: org_study_id