HPV Self-Sampling for Cervical Cancer

(Isbaar Trial)

Overseen By Christina Bliss Barsness

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: History of cervical cancer, hysterectomy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if HPV self-sampling kits in primary care can increase cervical cancer screening among Somali women aged 30-65 who are due for screening. Participants will either use the self-sampling kit (COPAN 552c.80 FLOQSwab) or receive the usual screening by a doctor. The study targets Somali women eligible for cervical cancer screening who haven't had a hysterectomy without an intact cervix. As an unphased trial, this study offers a chance to contribute to research that could enhance screening access and convenience for Somali women.

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 prior data suggests that HPV self-sampling is safe for cervical cancer screening?

Studies have shown that COPAN FLOQSwabs for HPV self-sampling are safe and comfortable for users. Research indicates that these swabs are gentle and preserve the sample well, making them a reliable choice for self-collection.

Previous studies suggest that self-sampling for HPV testing can increase participation in cervical cancer screening by eliminating the need for a clinical exam, which some find uncomfortable. The FDA has approved self-collection for HPV testing in healthcare settings, confirming it meets safety standards.

Overall, evidence shows that HPV self-sampling, particularly with COPAN FLOQSwabs, is generally safe and easy to use. There are no significant reports of negative effects, making it an appealing option for cervical cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HPV self-sampling for cervical cancer because it offers a new way for women to screen themselves at home, using COPAN FLOQSwabs, instead of needing to visit a clinic for a Pap smear. This method empowers women by providing a more private, convenient, and potentially less intimidating option. It could also increase screening rates, especially in communities with limited access to healthcare facilities, helping catch cervical cancer earlier.

What evidence suggests that HPV self-sampling is effective for cervical cancer screening?

Research has shown that HPV self-sampling, which participants in this trial may perform, can increase cervical cancer screening rates among women. Studies found that sending self-collection kits to previously unscreened women more than doubles their participation. This method is affordable and well-received by patients, making it a practical choice. Additionally, HPV self-sampling is cost-effective, offering good value for the results it provides. Overall, these findings suggest that HPV self-sampling could significantly boost screening among underserved groups. ^{6 7 8 9 10}

Who Is on the Research Team?

Rebekah Pratt, PhD

Principal Investigator

University of Minnesota

Rachel Winer, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. Sanner, K., Wikström, I., Gustavsson, I., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

An educational intervention significantly improved women's knowledge about HPV and cervical cancer among 302 participants, indicating that tailored information can enhance understanding of health issues.

Despite the increase in knowledge, the intervention did not significantly affect women's confidence or acceptability of the Self-HPV method, suggesting that further research is needed to explore long-term impacts on screening behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon. Sossauer, G., Zbinden, M., Tebeu, PM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524653/

Cost-effectiveness of human papillomavirus (HPV) self ... Our findings show that employing HPV self-collection was both affordable and effective in increasing cervical cancer screening uptake among underscreened, ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839517

Cost-Effectiveness of HPV Self-Testing Options for Cervical ... This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...

3. mdanderson.org mdanderson.org/newsroom/mailed-self-collection-hpv-tests-boost-cervical-cancer-screening.h00-159777234.html

Mailed self-collection HPV tests boost cervical cancer ... Mail-in self-collection tests for human papillomavirus (HPV) more than doubled cervical cancer screening participation among never- and under-screened US women.

4. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(23)00076-2/fulltext

Effect of HPV self-collection kits on cervical cancer ... Mailed HPV self-collected samples have the potential for even greater effects if the US Food and Drug Administration approve them for primary ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524000903

Self-sampling for HPV testing in cervical cancer screening The results showed that self-sampling has a good patient acceptance. •. The home-based procedure showed good cost-effectiveness. Abstract.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190028S009B.pdf

Summary of Safety and Effectiveness Data (SSED) This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39,. 45, 51, 52, 56, 58, 59, 66, and 68. cobas HPV is indicated for use for routine cervical ...

7. copangroup.com copangroup.com/product-ranges/self-floqswabs/

Self FLOQSwabs® Vaginal Discover Self-FLOQSwabs by Copan, designed for reliable self-collection and accurate diagnostics, ensuring patient comfort and sample integrity.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213294524001066

Validating Human Papillomavirus Self-Collection Testing ... Vaginal samples were self-collected using a COPAN FLOQswab 552c.80 swab, while clinicians collected routine cervical specimens. All samples underwent ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190028S009C.pdf

cobas® HPV - accessdata.fda.gov Sample handling instructions for self-collected sample using Copan FLOQSwabs® #552C.RM for testing with the cobas®. 4800 HPV Test or cobas® HPV. Self ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10535381/

Preliminary Results of Feasibility and Acceptability of Self- ... Vaginal self-sampling was collected using dry FLOQSwabs® 552C.80 (Copan Italia, SpA, Brescia, Italy), a flocked swab that consists of a molded ...