Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test
研究概览
简要总结
This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.
详细描述
The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Somali female age 25-70 years
- •have lived in the U.S. 10 years or less
- •have not had a Pap test (by self report) in the last 3 years
排除标准
- •Women with a self reported past history of any of the following will not be eligible:
- •total hysterectomy
- •cervical cancer
- •active history of cervical dysplasia
结局指标
主要结局
Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test
时间窗: Within 3 months after Enrollment
The main outcome will be successful completion of cervical cancer screening by 3 months after enrollment. For the Home Vaginal Biospecimen Collection Group, completion is defined as return of the HPV DNA self-sampling kit by the patient, with a sample suitable for laboratory analysis. In the Clinic Pap Test Group, completion is defined by documentation of Pap test result.
次要结局
未报告次要终点