Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Proportion of HPVss-positive women "well managed"
研究概览
简要总结
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.
详细描述
France has already implemented a cervical screening programme based on HPV test for the whole female population aged 30-65 years. Non-participant women can perform HPV test at their home. However, less than 20% of French women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less to cervical screening. A variety of personal, practitioner, test-related and logistical barriers negatively impact the screening participation of French women. Key barriers to participation could be addressed by overcoming disparities in HPV-related knowledge and perceptions about cervical cancer screening. This study aims to evaluate the impact of sending HPV self-sampling kit at women's home, associated with providing, through multiple mobile channels, a multi-language decision aid designed for women with lower education accessible via artificial intelligence-based ChatBot. This decision aid will help women review high quality evidence on cervical cancer disease and screening modalities.
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
- None
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
- 是
入选标准
- •eligible women will be:
- •aged 30-65
- •did not perform a pap smear in the last 4 years
- •are living in deprived clusters in the Occitanie region.
- •did not answer to a first "invitation" letter to perform a clinician-collected HPV testing
排除标准
- •ineligible women will be those:
- •outside the target age group
- •had a Pap smear in the past 3 years
- •had hysterectomy including cervix
- •are pregnant
- •already scheduled a screening appointment or had just attended a HPV screening
- •had a cervical abnormality that was under exploration and/or treatment.
- •participated to the study pilot
结局指标
主要结局
Proportion of HPVss-positive women "well managed"
时间窗: 1 year after postal mail
Percent of recruited women well managed (Percent of women screened and completing full pathway of HPV screening and treatment over 12 months). "Well managed" is defined as: completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND * for HPV negative women, woman advised of negative result * for HPV positive women, completed assessment.
Cost and cost-efficacy
时间窗: Month 36 - Month 48
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions are identified and valued. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between the intervention groups with the mean difference in effects, and expressed as both euros and US dollars per percentage change in screening participation.
HPV self-sampling "return" rate
时间窗: 1 year after postal mail
Percent of women recalled who "return" HPVss over 12 months "Return" means: 1) the receipt of the vaginal self-sample at the laboratory; 2) the performance of clinician-collected HPV testing for those who prefer to be screened by a health professional; and 3) Information about a recent screening or a cervical screening exclusion reason.
次要结局
未报告次要终点
研究者
Farida Selmouni
Principal Investigator
International Agency for Research on Cancer