Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Uptake of cervical cancer screening from self-sampling in the ED
概览
简要总结
This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.
详细描述
This is a single-arm pilot trial with a prospectively enrolled sample. The participants who complete the screening survey and are determined to be adherent (n ~ 600) will be notified that they appear to be adherent with current screening guidelines, and their participation ends at this point. These participants will be considered screen failures for study purposes. Women and transgender/non-binary individuals with a cervix, aged 30-65, will be recruited from a high-volume urban ED. Follow-up will occur at 150 days to determine CC screening activity, perceived and concrete barriers to care, and participant experiences with the intervention. Electronic Health Record (EHR) review will be conducted to corroborate participants' reports of screening activities and assess completion of clinic-based testing and clinical endpoints.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cisgender women and transgender/non-binary individuals with a cervix,
- •Age 30 - 65 years, and demonstrating decisional capacity to consent to participate with no known
排除标准
- •Exclusion Criteria:
- •Past hysterectomy with cervical removal
- •Known infection with HIV (as screening recommendations for people with HIV differ from the general population)
- •Inability to consent (e.g., lacking decisional capacity, intoxicated, or in distress)
- •Current pregnancy or in the three months after giving birth
- •Use of vaginal ovules, creams or washes, vaginal contraceptives or condoms within past 3 days
- •Sexual intercourse or transvaginal ultrasound scans or gynecological examinations within past 2 days
研究组 & 干预措施
Intervention Arm
Participants will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by study staff on how to self-sample using a defined instructional script written at an elementary reading level, (2) provided with a packaged swab, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms. Once self sampling has been completed, the study staff will then transfer the swab to a vial of transport media and forward the specimens to the laboratory for analysis. Participants recruited to the intervention arm that subsequently decline to or are unable to self-sample in the ED will remain in the study and will receive referral for clinic-based screening.
干预措施: Cervical Cancer Screening (Diagnostic Test)
结局指标
主要结局
Uptake of cervical cancer screening from self-sampling in the ED
时间窗: In about 150 days of enrollment
Number of subjects referred for additional screening who follow through with next steps in the screening process.
次要结局
未报告次要终点
研究者
Beau Abar
Professor
University of Rochester