Patient Compliance to Self-collection for Detection of HPV-DNA in Cervical Cancer Prevention: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compliance to self-collection for detection of HPV-DNA measured by the percentage of subjects that returned the vaginal self-collected sample or attended to the medical appointment according to allocation.
研究概览
简要总结
A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.
详细描述
Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.
The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 25-59 years-old
- •Not pregnant
- •Had held their last Pap smear for over a year
- •Could read.
排除标准
- •Women with previous hysterectomy
- •History of cervical cancer or its precursors
- •Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases)
- •Those who underwent self-collection of their specimen during menstrual period
研究组 & 干预措施
Self-collection
Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII).
干预措施: Self-collection (Procedure)
Gynecologist collection
Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
干预措施: Gynecologist collection (Procedure)
结局指标
主要结局
Compliance to self-collection for detection of HPV-DNA measured by the percentage of subjects that returned the vaginal self-collected sample or attended to the medical appointment according to allocation.
时间窗: One week after inclusion
Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel
次要结局
未报告次要终点