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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
3,367
The study will implement HPV self-sampling as an option for cervical cancer screening alongside usual care for Somali women, and evaluate changes pre and post implementation, compared to Fairview non-intervention clinics.
University of Minnesota
Minneapolis, Minnesota, United States
Difference-in-difference Comparison
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).
Time frame: Up to one-year (time-to-event) to initiate screening in each of the pre and post implementation periods.
Pre-implementation Period Cervical Cancer Screening Completion
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.
Time frame: Up to one-year (time-to-event) to initiate screening in the pre-implementation period.
Post-implementation Period Cervical Cancer Screening Completion.
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.
Time frame: Up to one-year (time-to-event) to initiate screening in the post implementation period.
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