NCT07171658

Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

Improving Cervical Cancer Screening Coverage Among Underscreened Women Aged 50 to 74 in Switzerland Using HPV Self-sampling Strategies: A Randomized Study - Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,500 (estimated)
• Sponsor: Jessica Di Vincenzo Sormani · Academic / Other
• Sex: Female
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

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. 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

Secondary objectives are: * 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

• Cervical Cancer Screening

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Home-based HPV self-sampling	Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Timeline

• Start date: 2025-10-07
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-09-12
• Last updated: 2025-12-22

Locations

1 site across 1 country: Switzerland