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HPV Self-Sampling for Cervical Cancer (Isbaar Trial)
N/A
Recruiting
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
Isbaar Trial 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.Check my eligibility
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.See study design
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.
Isbaar Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cervical cancer screening uptake rate
Isbaar 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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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,582,816 Total Patients Enrolled
Rebekah Pratt, MDPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 65 years old.I am eligible for cervical cancer screening.I am a Somali woman.I cannot have cervical cancer screening due to a history of cervical cancer or because I've had a hysterectomy without an intact cervix.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is younger than 50 years an accepted criterion for enrollment in this research endeavor?
"This trial is specifically looking for participants aged 30 to 65. Conversely, there are 226 studies accepting patients younger than 18 and 991 research initiatives recruiting individuals older than 65."
Answered by AI
Is this trial currently seeking to involve new participants?
"The information posted on clinicaltrials.gov reveals that, as of July 6th 2022, this trial is not enrolling participants. Initially shared on November 1st 2022, the study has been dormant for some time; yet there are still 1219 other trials looking for volunteers at present."
Answered by AI
Is there a specific group of individuals that would be ideal candidates for this trial?
"This research is enrolling 5,680 participants with papillomavirus infections aged between 30 and 65. Pivotally, the selection criteria necessitate that applicants be Somali female individuals able to undergo cervical cancer screening."
Answered by AI
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