HPV Self-Sampling for Cervical Cancer (Isbaar Trial)

N/A

Waitlist Available

Led By Rebekah Pratt, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one-year (time-to-event) following intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether making it easier for Somali women to screen for cervical cancer will increase the number of women getting screened.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

There may not be significant side effects from using the COPAN FLOQSwab for HPV self-sampling; however, some individuals might experience mild discomfort or emotional distress during the self-collection process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one-year (time-to-event) following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one-year (time-to-event) following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one-year (time-to-event) following intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cervical cancer screening uptake rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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