HPV Self-Sampling in Somali Women (Isbaar Project)

Primary outcomes

1. Difference-in-difference Comparison

   Time frame: 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).

2. Pre-implementation Period Cervical Cancer Screening Completion

   Time frame: 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.

3. Post-implementation Period Cervical Cancer Screening Completion.

   Time frame: 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:

   • receiving Pap and/or HPV testing by a clinician;
   • self-sampling HPV-negative or HPV16/18+; or
   • 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.