Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

NCT07171658 | Recruiting DMC

• 1 other identifier: 32HW-0_228666
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland. This randomized trial will compare three arms:

1. 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. 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. 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.

Conditions

Cervical Cancer Screening

Keywords

cervical cancer screening; underscreened women; HPV self-sampling; Integrated approach

Outcome Measures

Primary Outcomes (1)

• Participation to Cervical Cancer Screening (CCS)

  Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %

  12 months

Secondary Outcomes (7)

• Correlation of socio-demographic characteristics with screening participation

  12 months

• Choice of primary screening methods (HPV testing vs cytology)

  12 months

• Prevalence of positive primary screening (HPS test) and triage results (cytology)

  12 months

• Follow-up rates for participants screened positive

  12 months

• Acceptability of screening strategies

  12 months

Study Arms (2)

Intervention Group 1: Sensitization to Cervical Cancer (CC) screening

EXPERIMENTAL

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Behavioral: Sensitization to Cervical Cancer (CC) screening

Intervention Group 2: Home-based HPV self-sampling

EXPERIMENTAL

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Behavioral: Home-based HPV self-sampling

Interventions

Home-based HPV self-sampling BEHAVIORAL

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Intervention Group 2: Home-based HPV self-sampling

Sensitization to Cervical Cancer (CC) screening BEHAVIORAL

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 1: Sensitization to Cervical Cancer (CC) screening

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)
• 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)

You may not qualify if:

• Prior cervical cancer diagnosis,
• Hysterectomy
• Non consent to participate to the study
• Incapable of judgment or under tutelage
• Pregnancy

Sponsors & Collaborators

• Jessica Di Vincenzo Sormani: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Jessica Di Vincenzo Sormani, PhD

  Haute École de Santé de Genève (HEdS-GE)

  STUDY DIRECTOR

Central Study Contacts

Jessica Di Vincenzo-Sormani, PhD

CONTACT

+41 22 558 58 78; jessica.di-vincenzo-sormani@hesge.ch

Patrick Petignat, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor assistant (tenure track)

Model Details: The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 12, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CH (1)