HPV Self-Sampling for Cervical Cancer
(Isbaar Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRebekah Pratt, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Minnesota

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rebekah Pratt, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for Somali women aged 30-65 who are due for cervical cancer screening. Participants must identify as Somali and be eligible for the screening, meaning they haven't had a hysterectomy that removed their cervix or a history of cervical cancer.

Inclusion Criteria

I am between 30 and 65 years old.

I am eligible for cervical cancer screening.

I am a Somali woman.

Exclusion Criteria

I cannot have cervical cancer screening due to a history of cervical cancer or because I've had a hysterectomy without an intact cervix.

Treatment Details

Interventions

COPAN 552c.80 FLOQSwab (Device)
COPAN 552c FLOQSwab (Device)
HPV Self-Sampling (Procedure)

Trial OverviewThe study is testing whether using HPV self-sampling kits (COPAN 552c.80 FLOQSwab) can increase the number of Somali women who participate in cervical cancer screenings when offered in primary care settings.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 II: ControlActive Control1 Intervention

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.