Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT07171658
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
Sponsor:
Jessica Di Vincenzo Sormani
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAICS
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. 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: