HPV Self-Sampling in Somali Women (Isbaar Project)

Not Applicable

Completed

• Conditions: Uterine Diseases; Uterine Cervical Disease; Cervical Cancer; Papillomavirus Infection

• Registration Number: NCT05453006
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-12
• Study Start: 2023-02-20
• Primary Completion: 2024-05-19
• Study Completion: 2025-05-19
• Results First Submitted: 2025-05-19
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Results First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3367

Inclusion Criteria

• Identify as a Somali woman
• between ages of 30-65
• eligible for cervical cancer screening

Exclusion Criteria

• Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference-in-difference Comparison	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	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.	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States