HPV Self-Sampling in Somali Women

Not Applicable

Active, not recruiting

• Conditions: Uterine Diseases; Uterine Cervical Disease; Cervical Cancer; Papillomavirus Infection
• Interventions: Device: COPAN 552c.80 FLOQSwab

• 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
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Study Completion: 2025-05-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 5680

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

Arm && Interventions

Group	Intervention	Description
Intervention	COPAN 552c.80 FLOQSwab	At the three intervention clinics, clinic providers or staff will offer women the option to perform HPV self-sampling as an alternative to cervical cancer screening by a clinician.

Primary Outcome Measures

Name	Time	Method
Cervical cancer screening uptake rate	up to one-year (time-to-event) following intervention	The operational definition of screening uptake accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening uptake 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, the screening uptake date will be the date of the follow-up Pap test; if the Pap test is not completed, the woman will not be considered screened.

Trial Locations

Locations (1)

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