Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,367
- 试验地点
- 1
- 主要终点
- Difference-in-difference Comparison
研究概览
简要总结
This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Identify as a Somali woman
- •between ages of 30-65
- •eligible for cervical cancer screening
排除标准
- •Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
研究组 & 干预措施
Intervention
At the three intervention clinics, clinic providers or staff will offer women the option to perform HPV self-sampling as an alternative to cervical cancer screening by a clinician.
干预措施: COPAN 552c.80 FLOQSwab (Device)
Control
Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics.
结局指标
主要结局
Difference-in-difference Comparison
时间窗: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
Difference-in-difference Cox proportional hazards regression to compare screening completion changes 12-months pre- /post-implementation in intervention versus control clinics, adjusting for age, screening history, and CDC social vulnerability index (SVI).
Pre-implementation Period Cervical Cancer Screening Completion
时间窗: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.
For the pre-implementation period (prior to intervention clinics offering the option to perform HPV self-sampling), the operational definition of screening completion is receiving Pap and/or HPV testing by a clinician.
Post-implementation Period Cervical Cancer Screening Completion.
时间窗: Up to one-year (time-to-event) to initiate screening in the post implementation period.
For the post-implementation period, the operational definition of screening completion accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening completion as: 1. receiving Pap and/or HPV testing by a clinician; 2. self-sampling HPV-negative or HPV16/18+; or 3. self-sampling positive for other high-risk HPV types (i.e., "HPV+ other") or unsatisfactory and returning for a follow-up Pap test to complete the screening episode. For women with "HPV+ other" or unsatisfactory test results on self-sampling, a follow-up Pap test is required; if the Pap test is not completed within 3 months, the woman will not be considered screened.
次要结局
未报告次要终点