Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
研究概览
简要总结
One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.
详细描述
Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent for statistical data processing and consent to the processing of personal data
- •HPV test never performed or performed more than 3 years ago or patient does not know
排除标准
- •Refusal to participate
- •Pregnancy and puerperium
- •History of hysterectomy
- •HPV test performed <3 years ago with negative result
- •Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).
结局指标
主要结局
To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
时间窗: Through study completion, an average of 1 year
To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort.
Evaluation of the frequency of positivity of the HPV tests taken.
时间窗: Through study completion, an average of 1 year
Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort.
Evaluation of follow-up gynaecological care in women who tested positive.
时间窗: Through study completion, an average of 1 year
To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit.
次要结局
未报告次要终点