HPV Self-Sampling in Somali Women (Isbaar Project)

University of Minnesota (UMN)

Status: Completed

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

Treatments: Device: COPAN 552c.80 FLOQSwab

Study type: Interventional

Funder types: Other

Identifiers

NCT05453006

FMCH-2019-27849

Details and patient eligibility

About

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.

Enrollment: 3,367 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,367 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Device: COPAN 552c.80 FLOQSwab

Control

No Intervention group

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.