Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Participation
研究概览
简要总结
Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Greater participation has been demonstrated with the use of HPV self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. The aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.
详细描述
The investigators will perform a randomized clinical trial with three arms including: regular HPV with cytology triage, colpo/biopsy, and treatment if indicated; HPV self-collection without cytology triage but with colpo/biopsy and treatment if indicated, HPV self-collection with immediate treatment for women with positive test results. This study will be carried out in two different settings with differential access to diagnosis and treatment. Two methods will be used for inviting women and collecting samples: mail and door-to-door. Participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.
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
- 否
入选标准
- •Women 30-65 years old
- •No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- •Be linked to one of the health providing entities participating in the study
- •Women who sign the informed consent.
排除标准
- •Women 30-65 years old
- •No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- •Be linked to one of the health providing entities participating in the study
- •Women who sign the informed consent.
结局指标
主要结局
Participation
时间窗: 1 year
Number of women that undergo the screening test / total number of women invited.
Adherence
时间窗: 1 year
Number of women that undergo the screening test + women who completed the diagnosis and treatment process / total number of women invited + total number of women with a positive screening in follow-up protocols.
次要结局
- Quality of HPV samples(1 year)
- CIN2 + rate in the study population(1 year)
- CIN2 + rate in population with positive screening(1 year)