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临床试验/NCT05453006
NCT05453006已完成不适用

Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention

University of Minnesota2 个研究点 分布在 1 个国家目标入组 3,367 人开始时间: 2023年2月20日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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