The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions.
The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Valid Pap smear in last 1-3 months obtained at participating clinic
- •18 years or older
- •Self-report being able to read in English and/or Spanish
- •Willing to sign informed consent
排除标准
- •Used vaginal product (douche, spermicide, antifungal) in last 48 hours
- •Last menses started ≤ 4 days prior to enrollment visit
- •No uterus / history of hysterectomy
- •Self-report currently pregnant
- •Self-report currently breastfeeding
结局指标
主要结局
Sensitivity and Specificity
时间窗: 1-3 months between 2 specimen collections
We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints.
Kappa Coefficient
时间窗: 1-3 months between 2 specimen collections
Kappa comparing clinician-collected cytology result to self-lavage cytology result
次要结局
- Outcome: Acceptability of Device(cross-sectional - asked at time of Screener use)
研究者
Carolyn L. Westhoff
Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center
Columbia University