HPV Self-Sampling in Somali Women (Isbaar Project)

NCT ID: NCT05453006

Last Updated: 2025-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2025-05-19

Brief Summary

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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

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Conditions

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Cervical Cancer Papillomavirus Infection Uterine Diseases Uterine Cervical Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

COPAN 552c.80 FLOQSwab

Intervention Type DEVICE

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 non-intervention clinics.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 non-intervention clinics.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebekah Pratt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Rachel Winer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FMCH-2019-27849

Identifier Type: -

Identifier Source: org_study_id

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