HPV Self-Sampling in Somali Women

Cervical Cancer Clinical Trial

— Isbaar  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05453006
• Other study ID #: FMCH-2019-27849
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5680
• Est. completion date: May 31, 2025
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Infections
• Papillomavirus Infection
• Papillomavirus Infections
• Uterine Cervical Disease
• Uterine Cervical Diseases
• Uterine Cervical Neoplasms
• Uterine Diseases

Intervention

Device:
• COPAN 552c.80 FLOQSwab
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 intervention clinics.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical cancer screening uptake rate	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: 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, 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.	up to one-year (time-to-event) following intervention