5680 Participants Needed

HPV Self-Sampling for Cervical Cancer

(Isbaar Trial)

CB
Overseen ByChristina Bliss Barsness
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the HPV Self-Sampling treatment for cervical cancer?

Research shows that HPV self-sampling is a well-accepted and effective method for women who do not attend regular cervical cancer screenings, increasing participation and potentially improving early detection of high-risk HPV infections.12345

Is HPV self-sampling safe for humans?

The research does not provide specific safety data for HPV self-sampling, but it is generally well-accepted and used worldwide for cervical cancer screening, suggesting it is considered safe for human use.14567

How is the HPV Self-Sampling treatment for cervical cancer unique?

The HPV Self-Sampling treatment is unique because it allows women to collect their own samples at home using a swab, making it more convenient and potentially increasing participation in cervical cancer screening. This method is particularly beneficial in low-resource settings where access to healthcare facilities may be limited.148910

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

RP

Rebekah Pratt, PhD

Principal Investigator

University of Minnesota

RW

Rachel Winer, PhD

Principal Investigator

University of Washington

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are offered HPV self-sampling as an alternative to cervical cancer screening by a clinician

up to one year

Follow-up

Participants are monitored for cervical cancer screening uptake and follow-up Pap tests if necessary

up to one year

Treatment Details

Interventions

  • COPAN 552c.80 FLOQSwab
  • COPAN 552c FLOQSwab
  • HPV Self-Sampling
Trial Overview 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.
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

In a study of 479 women treated for high-grade cervical intraepithelial neoplasia (CIN), nearly 75% expressed willingness to perform HPV self-sampling before their next gynecologic follow-up, indicating strong acceptance of this method.
Confidence in performing HPV self-sampling was a key factor influencing willingness, although it was lower compared to traditional methods like Papanicolaou smears, highlighting the need for increased education and support around self-sampling techniques.
Is self-sampling to test for high-risk papillomavirus an acceptable option among women who have been treated for high-grade cervical intraepithelial neoplasia?Andersson, S., Belkić, K., Mints, M., et al.[2022]
A study involving 25 women (12 premenopausal and 13 postmenopausal) showed that daily self-sampling for high-risk HPV (HR-HPV) resulted in consistent detection of the virus, with 98% of samples showing stable results over the sampling period.
The findings indicate that a single self-sample is reliable for detecting ongoing HR-HPV infections, regardless of the menstrual cycle phase, suggesting that self-sampling could be an effective method for cervical cancer screening.
Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing.Sanner, K., Wikström, I., Gustavsson, I., et al.[2017]
Self-collection of cervical samples for hr-HPV detection showed a significant error rate, with 9.1% of samples at UZ Ghent and 17.6% at AML failing to provide an internal control signal, indicating potential issues with sample quality.
Despite the high error rates, the prevalence of hr-HPV in the valid samples was 18.8%, suggesting that self-collection could still be a viable method for screening, but adjustments in testing protocols may be needed to account for differences in sample collection methods.
Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed.Verberckmoes, B., De Vos, T., Maelegheer, K., et al.[2023]

References

Is self-sampling to test for high-risk papillomavirus an acceptable option among women who have been treated for high-grade cervical intraepithelial neoplasia? [2022]
Acceptance of Self-Sampling Among Long-Term Cervical Screening Non-Attenders with HPV-Positive Results: Promising Opportunity for Specific Cancer Education. [2023]
Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. [2017]
Comparison of Different Self-Sampling Devices for Molecular Detection of Human Papillomavirus (HPV) and Other Sexually Transmitted Infections (STIs): A Pilot Study. [2022]
To what extent will women accept HPV self-sampling for cervical cancer screening? A qualitative study conducted in Switzerland. [2020]
Evaluation of the feasibility of human papillomavirus sponge-type self-sampling device at Japanese colposcopy clinics. [2023]
Self-Sampling for Human Papillomavirus Testing: Acceptability in a U.S. Safety Net Health System. [2023]
Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]
Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Randomized Comparison of Two Vaginal Self-Sampling Methods for Human Papillomavirus Detection: Dry Swab versus FTA Cartridge. [2018]
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