A New Approach to Cervical Cancer Prevention in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.
研究概览
简要总结
The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.
详细描述
The purpose of this study is to test the hypothesis that effective cervical cancer screening can be performed in a high percentage of women, using HPV DNA of self-collected vaginal samples, provided by women attending either chamas (community groups) or in their own homes. HPV DNA testing will be used to triage women for a secondary screen by visual inspection with acetic acid (VIA) in a local clinic. The investigators will determine if HPV DNA testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care. In addition, women will bring their children to be vaccinated against HPV in these community meetings, using the standard of care for the approved HPV vaccine available in Kenya.
The investigators will test this approach by completing the following Specific Aims:
Specific Aim 1: Determine the percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.
Specific Aim 2. Following HPV DNA screening using self-collected swabs, determine the percentage of these women who will attend the local clinic.
Specific Aim 3. Evaluate the statistical correlation between HPV DNA testing of self-collected vaginal swabs and VIA (as all women in this pilot study will undergo VIA).
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who live in Kenya who are between the ages of 30 and 55, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA
排除标准
- •current pregnancy, inability to consent due to mental or physical disability, or a medical illness that has rendered the patient unable to understand consent
结局指标
主要结局
Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.
时间窗: anytime after informed consent up to 2 years
Percentage of women who attend clinic after providing self-collected vaginal swabs
时间窗: any time after completion of self-collected vaginal swab (up to 2 years)
次要结局
- HPV DNA vaginal swab testing results(any time after after self-collected vaginal swab, up to 2 years)
- Visual inspection with acetic acid (VIA) testing results(any time after VIA is performed, up to 2 years)
研究者
Darron Brown MD, MPH
Professor of Medicine
Indiana University