Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- performing a HPV test within 3 months since the recall letter
研究概览
简要总结
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.
Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.
详细描述
In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands).
With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer.
The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall
排除标准
- •does not meet inclusion criteria
结局指标
主要结局
performing a HPV test within 3 months since the recall letter
时间窗: up to december 2012 (up to 3 months)
次要结局
- How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)(up to december 2012 (up to 3 months))
研究者
Emma Altobelli
Responsable U.O. Epidemiology and Social Marketing
Azienda Sanitaria Locale 4, Teramo