Acceptability, Optimization and Cost-effectiveness for Self-sampling Cervical Cancer Screening.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,614
- 试验地点
- 6
- 主要终点
- Self-sampling acceptability for cervical cancer screening
研究概览
简要总结
Main objectives:
1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method.
1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling.
Project methodology:
Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random:
- Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic.
- No prior trainning group): Same training without practicing self-sampling collection.
Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use.
Acceptability will be analyzed according to two definitions:
- proportion of women who returned the self-sampling device,
- proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire.
HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain.
Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche.
详细描述
Women aged 30-65 years regular user of cervical cancer screening, not pregnant and with no history of cervical disease are recruited at the cervical cancer screening clinics.
Women are recruited in two Spanish distant areas, Catalonia with participant clinics in Cerdanyola del Vallés, Barberà del Vallés, Ripollet, Badia del Vallés and Sabadell, and the Canary Islands, including the clinics of Arucas, Gáldar, Prudencio Guzmán, Telde, Vecindario, Maspalomas. In both areas the cervical cancer screening was free of charge, opportunistic with cytology as primary test.
Women who agreed to participate in the study signs an informed consent and are provided with a short questionnaire including sociodemographic and screening history information.
Women are randomised, as they came to the screening visit, in two groups:
- Training group: The trained provider shows the woman how to use the self-sampling device and asks her to collect her self-sample immediately after, at the health centre. Then, the provider gives her a new device to take a new sample at home and send it back to the health center in a month time.
- No prior training group: The health provider shows the woman how to use self-sampling device and gives the woman a device for her to take a sample at home in a month interval and send it back to the health center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).
排除标准
- •Women under 30 years of age.
- •Women over 65 years of age.
- •Pregnant women.
- •Women with hysterectomy.
- •Women between 30 and 65 years of age who underwent the last screening test more than four years ago.
- •Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology.
结局指标
主要结局
Self-sampling acceptability for cervical cancer screening
时间窗: 2 months
Acceptability will be compared by study arm and evaluated as 1) proportion of women that return the self-sampling device, 2) proportion of women that return the self-sampling device and respond to favour future screening with self-sampling. This will be evaluated according to the sociodemographic variables of the participants and the results of the acceptability questionnaire that each woman has filled out.
次要结局
- HPV test agreement between self-sampling and clinician-collected samples(2 months)
- The cost-effectiveness of cervical Self-Sampling on public health system in Spain(This is a mathematical and cost analisis. No participants are assessed (time frame 2 years))
研究者
Raquel Ibáñez
Principal investigator
Institut d'Investigació Biomèdica de Bellvitge