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
- 2
- 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
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
