Natural History of HPV Infections in Mid-Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples
研究概览
简要总结
The purpose of this study is to determine rates of oral and genital human papillomavirus (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.
详细描述
The investigators propose a longitudinal study of 500 women in order to determine rates and risk factors for HPV infections in 30-50 year old women. Participants will be followed for 6 months and will be asked to complete online questionnaires on their health, sexual behavior, HPV vaccinations, and cervical cancer screening. The investigators will ask participants to self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. Women will also be asked to provide 2 blood samples. All swab samples will be tested for type-specific HPV deoxyribonucleic acid (DNA) using a polymerase chain reaction (PCR)-based assay, blood samples will be tested for HPV antibodies.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •affiliated with the University of Washington (student, staff, faculty)
- •willing to self-collect vaginal samples at home for HPV testing
- •able to provide informed consent
排除标准
- •have had hysterectomy
- •serious medical condition which prevents completion of activities of daily living
结局指标
主要结局
Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples
时间窗: once a month for 6 months
次要结局
未报告次要终点
研究者
Rachel Winer
Assistant Professor
University of Washington