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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
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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:
Secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Intervention Group 2: Home-based HPV self-sampling | Experimental | Women will receive a free-of-charge vaginal self-sampling kit for HPV infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of socio-demographic characteristics with screening participation | Regression coefficients of screening in the past 12 months for: education level, occupation, relationship status, sexual orientation, mother tongue, country of origin, residential area, children, follow-up by general practitioner or gynecologist, age, number of years living in Switzerland, Body Mass Index (calculated based on weight and height). Measurement tool: self-reported from questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Di Vincenzo-Sormani, PhD | Contact | +41 22 558 58 78 | jessica.di-vincenzo-sormani@hesge.ch | |
| Patrick Petignat, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Di Vincenzo Sormani, PhD | Haute École de Santé de Genève (HEdS-GE) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Recruiting | Geneva | Canton of Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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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 .
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| Home-based HPV self-sampling | Behavioral | Women will receive a free-of-charge vaginal self-sampling kit for HPV infection. |
|
| 12 months |
| Choice of primary screening methods (HPV testing vs cytology) | Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm. | 12 months |
| Prevalence of positive primary screening (HPS test) and triage results (cytology) | Difference between study arms of the:
| 12 months |
| Follow-up rates for participants screened positive | Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage | 12 months |
| Acceptability of screening strategies | Difference between study arms of the: - Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied) | 12 months |
| Reasons for non-compliance | Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance | 12 months |
| Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors | Difference in the study arms: of the proportion (%) of participants having done all screenings, and participants having selected only one or two screenings, and participants having done none. | 12 months |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |