At-Home HPV Self-Sampling for Cervical Cancer Screening

Overseen By Leonard Kishel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pregnant, Incarcerated, Compromised immune, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a self-sampled HPV test can encourage more participation in cervical cancer screening. Participants will use a simple brush at home (the Evalyn Self-Sampling Brush) to collect their own sample, which they will send to a lab for testing. This method is compared to the usual approach, where a doctor collects the sample. The trial seeks participants eligible for cervical cancer screening who haven't done it recently and are not considered at high risk for cervical cancer. Those who speak English or Spanish and seek a more convenient screening option might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could make cervical cancer screening more accessible and convenient.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on cervical cancer screening methods, so it's unlikely that your medications will be affected, but you should confirm with the study team.

What prior data suggests that the Evalyn Self-Sampling Brush is safe for HPV testing?

Research has shown that the Evalyn Self-Sampling Brush is safe and easy to use. This tool allows individuals to collect their own samples for HPV testing. Designed to be painless and reliable, the brush can detect HPV for up to 32 weeks, even in varying temperatures.

Although specific safety data on this brush is limited, similar self-sampling tools for HPV testing have been well-received in other studies. This trial uses the brush to encourage more participation in screenings, emphasizing user comfort and safety.

In summary, while direct safety data is limited, the Evalyn Brush is expected to be safe based on its design and use in similar contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional cervical cancer screenings that require a visit to a healthcare provider for a Pap smear or HPV test, the Evalyn Self-Sampling Brush allows women to collect their own samples at home. This new method is exciting because it empowers women to take control of their health in a more convenient and private manner. By providing a simple self-sampling kit that includes everything needed to collect and send a sample to the lab, researchers hope this approach will increase screening rates and early detection of cervical cancer, ultimately improving outcomes for women.

What evidence suggests that the Evalyn Self-Sampling Brush is effective for increasing cervical cancer screening participation?

Research has shown that the Evalyn Self-Sampling Brush, used by participants in this trial, is a reliable tool for testing HPV, crucial for cervical cancer screening. Studies have found that self-sampling devices like the Evalyn Brush are safe and accurate, providing an alternative to tests conducted by doctors. This method remains stable, performing well even when samples are stored at varying temperatures for several weeks. Additionally, this approach can increase participation in cervical cancer screenings due to its convenience and at-home use. Overall, the Evalyn Brush effectively collects samples needed to detect HPV, aiding in the early detection of cervical cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Christina Scartozzi, DO

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who are overdue for cervical cancer screening, can communicate in English or Spanish, and are not at high risk for cervical cancer. It's not suitable for those who are pregnant, incarcerated, already have high-grade precancerous lesions, cannot communicate in the required languages, or have a compromised immune system.

Inclusion Criteria

I am overdue for my cervical cancer screening.

I can speak, read, and communicate well in English or Spanish.

I am not at high risk for cervical cancer.

Exclusion Criteria

I have been diagnosed with high-grade precancerous cervical changes.

Incarcerated

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Enrollment and Intervention

Participants are offered a choice between self-sampled HPV test or clinician-sampled test

12 months

1 visit (in-person) for initial recruitment

Follow-up

Participants' test results are processed and follow-up actions are taken based on results

3 months after study enrollment ends

What Are the Treatments Tested in This Trial?

Interventions

• Evalyn Self-Sampling Brush

Trial Overview The study tests if offering self-sampling HPV tests increases participation in cervical cancer screenings compared to the standard clinician-sampled test. It measures how acceptable the self-test is to patients and whether they complete it.

How Is the Trial Designed?

Group I: Requested self-sampled HPV test Experimental Treatment 1 Intervention

This group will receive the self-sampled HPV test. Included with the test are the test instructions, a lab requisition form, and a pre-paid mailer so that it can be sent back to the lab for testing. Results of the test will be shared with the participant.

Evalyn Self-Sampling Brush is already approved in United States for the following indications:

Approved in United States as Evalyn Brush for:

• Cervical cancer screening

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

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]

The Evalyn Brush self-sampling device for hrHPV detection showed a high agreement (85.8% to 86.6%) with physician-obtained samples, indicating it is an effective alternative for cervical cancer screening.

Women found the self-sampling experience highly acceptable, with 98% rating it as good to excellent and 95% preferring it over traditional physician sampling, suggesting it could increase participation in cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. van Baars, R., Bosgraaf, RP., ter Harmsel, BW., et al.[2022]

Over half of the 233 women surveyed reported discomfort with traditional clinic-based cervical cancer screenings, citing feelings of embarrassment and discomfort with male providers, particularly among Spanish speakers.

The majority of women who used the at-home HPV self-sampling kits found them to be less embarrassing, less stressful, and more convenient than traditional Pap tests, suggesting that these kits could effectively reduce barriers to screening for under-screened populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Parker, S., Deshmukh, AA., Chen, B., et al.[2023]

Cervicovaginal self-sampling using the Evalyn Brush for hr-HPV testing showed a 97.5% agreement with physician-collected samples, indicating it is a reliable method for detecting high-risk HPV.

The self-sampling method identified hr-HPV in 93.5% of patients with cervical intraepithelial neoplasia grade 3 or worse, demonstrating its effectiveness in identifying significant cervical disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. Chen, K., Ouyang, Y., Hillemanns, P., et al.[2017]

Self-collected cervicovaginal lavage for HPV testing showed high concordance (93%) with results from traditional cervical smears, indicating it could be a reliable alternative for cervical cancer screening.

While 88% of women found the self-sampling device acceptable, the concordance for cytology results was lower (54% with doctor and 41% with patient), suggesting that self-sampling is more effective for HPV testing than for cytology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. Nobbenhuis, MA., Helmerhorst, TJ., van den Brule, AJ., et al.[2022]

In a study involving 14,765 women using vaginal self-sampling for HPV testing, the detection rate of HPV was significantly higher (17.1%) compared to the cervical sampling group (4.5%), indicating that self-sampling may identify more HPV-positive cases.

Despite the higher HPV detection rate in the self-sampling group, the prevalence of severe dysplasia was similar in both groups (0.48% for self-sampling and 0.47% for cervical sampling), suggesting that self-sampling could effectively replace traditional cervical screening methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening: a randomised controlled trial. Hellsten, C., Ernstson, A., Bodelsson, G., et al.[2023]

Offering brush-based vaginal self-sampling for hrHPV testing significantly increased participation rates among non-attending women, with a response rate of 30.8% compared to only 6.5% in the control group.

The self-sampling method showed a high concordance rate of 68.8% with physician-taken samples, and among women with CIN2+/CIN3+, the concordance for hrHPV positivity was even higher at 95.5%, indicating that self-sampling is effective for detecting high-risk HPV and related cervical lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Gök, M., van Kemenade, FJ., Heideman, DA., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10821625/

Comparison of diagnostic accuracy and acceptability of self ... This study aims to compare different types of HPV self-sampling devices for cervical cancer screening to identify the most accurate and acceptable device(s).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07111819?aggFilters=status%3A

Study Details | Cervical Cancer Screening Via Self-sampling For the project purposes different types of self-sampling kits will be used - Evaline Brush, Copan self-sampling swab, the BGI company HPV self- ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834245

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...

4. nature.com nature.com/articles/s41416-025-03102-5

HPValidate—human papillomavirus testing with DNA and ... Five self-sampling workflows were studied within the routine English cervical screening programme; the cobas HPV DNA and APTIMA HPV mRNA assays ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405852118300089

Time and temperature dependent analytical stability of dry ... The Evalyn brush is analytically stable with respect to human genomic material and HPV detection for up to 32 weeks at temperatures ranging from 4 °C to 30 °C.

6. roversmedicaldevices.com roversmedicaldevices.com/cell-sampling-devices/evalyn-brush/

Evalyn® Brush The Evalyn® Brush is a single use (self-)sampler device that allows easy, painless, safe and reliable collection of vaginal/cervical specimens that can be used ...

7. 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 in the specimens listed below. Clinician-collected ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07111819

Cervical Cancer Screening Via Self-sampling For the project purposes different types of self-sampling kits will be used - Evaline Brush, Copan self-sampling swab, the BGI company HPV self-sampling kit.