Back to resultsHPV Self-Sampling in Somali Women (Isbaar)
Primary Purpose
Cervical Cancer, Papillomavirus Infection, Uterine Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPAN 552c.80 FLOQSwab
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women, primary care, cancer screening
Eligibility Criteria
Inclusion Criteria:
- Identify as a Somali woman
- between ages of 30-65
- eligible for cervical cancer screening
Exclusion Criteria:
- Currently pregnant
- Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics.
Outcomes
Primary Outcome Measures
Cervical cancer screening uptake rate
Our 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 follows: a) receiving Pap and/or HPV testing by a clinician; b) completing a self-sampling kit that is negative for all HPV or is HPV16/18+; or c) completing a self-sampling kit that is negative for HPV16/18 but positive for other types (i.e., "HPV+ other") or unsatisfactory.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05453006
Brief Title
HPV Self-Sampling in Somali Women
Acronym
Isbaar
Official Title
Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Case-based HPV Self-sampling Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
May 19, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Papillomavirus Infection, Uterine Diseases, Uterine Cervical Disease
Keywords
DNA virus infections, virus diseases, infections, tumor virus infections, papilloma, uterine diseases, uterine cervical diseases, Somali women, primary care, cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics.
Intervention Type
Device
Intervention Name(s)
COPAN 552c.80 FLOQSwab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cervical cancer screening uptake rate
Description
Our 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 follows: a) receiving Pap and/or HPV testing by a clinician; b) completing a self-sampling kit that is negative for all HPV or is HPV16/18+; or c) completing a self-sampling kit that is negative for HPV16/18 but positive for other types (i.e., "HPV+ other") or unsatisfactory.
Time Frame
up to one-year (time-to-event) following intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Bliss Barsness
Phone
612-625-7179
Email
blis0015@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebekah Pratt, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Bliss Barsness
Phone
612-625-7179
Email
blis0015@umn.edu
12. IPD Sharing Statement
Learn more about this trial
HPV Self-Sampling in Somali Women
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