Eligibility and Participation Characteristics of a Pilot Study of Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation
研究概览
简要总结
Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number
排除标准
- •Adults assigned as female at birth age 0-17
- •Adults assigned as female at birth age > 65
- •Adults assigned as male at birth
- •Adults assigned as female at birth without a Mayo Clinic medical record number
研究组 & 干预措施
Observational aim 1 & aim 3
Patients may choose to undergo HPV vaginal swab self-collection on study in the research clinic or at home. Patients may choose to complete an interview on study. In addition, patients have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Observational aim 2
Patients are contacted by the study Clinical Research Coordinator (CRC) by phone on study and informed of HPV vaccination eligibility, asked interest in being vaccinated, and informed of sites for HPV vaccination. Patients are then contacted again by the CRC to determine if HPV vaccination occurred.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation
时间窗: Baseline
Will be assessed by the percentage of women between 25-65 eligible for cervical cancer screening who participate or who opt not to participate in self-collection.
HPV vaccination following ED presentation
时间窗: One month
Will be assessed by the percentage of women between 18-26 eligible for HPV vaccination for cervical cancer prevention who participate in HPV vaccination. Participants will be contacted one month after initial contact to determine if the HPV vaccination was administered.
Interviews of women who decline self-collection
时间窗: Baseline
Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.
Interviews of women who consent to self-collection but do not complete the self-collection
时间窗: Up to 6 weeks
Phone or video-based interviews will be conducted with participants who agree to participate but do not complete self-collection after 4 weeks to determine reasons for non-participation.
Interviews of women who complete the self-collection
时间窗: Up to 6 weeks
Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.
次要结局
未报告次要终点