NCT07171658招募中不适用
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
Jessica Di Vincenzo Sormani2 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2025年10月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,500
- 试验地点
- 2
- 主要终点
- Participation to Cervical Cancer Screening (CCS)
研究概览
简要总结
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:
- 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.
- 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
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Prior cervical cancer diagnosis,
- •Hysterectomy
- •Non consent to participate to the study
- •Incapable of judgment or under tutelage
- •Pregnancy
结局指标
主要结局
Participation to Cervical Cancer Screening (CCS)
时间窗: 12 months
Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %
次要结局
- Reasons for non-compliance(12 months)
- 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)
- Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors(12 months)
研究者
Jessica Di Vincenzo Sormani
Professor assistant (tenure track)
School of Health Sciences Geneva
研究点 (2)
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