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

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the effectiveness of offering self-sampled human papillomavirus (HPV) tests in increasing participation in cervical cancer screening, compared to the standard of care clinician-sampled test. The primary study endpoints are (1) patients' acceptability of self-sampled HPV tests vs. clinician-sampled test, and (2) patients' completion of self-sampled HPV test. The secondary study endpoint to be measured is the increase in cervical cancer screenings of any type in the PSH St. Joseph's residency clinic patient population.

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 data supports the effectiveness of the treatment Evalyn Self-Sampling Brush for cervical cancer screening?

Research shows that the Evalyn Brush for self-sampling is as effective as samples taken by doctors for detecting high-risk HPV, which is linked to cervical cancer. Additionally, most women found the self-sampling method easy to use and preferred it over traditional methods. ^{1 2 3 4 5}

How is the Evalyn Self-Sampling Brush treatment different from other cervical cancer screening methods?

The Evalyn Self-Sampling Brush allows women to collect their own samples at home for HPV testing, making it more convenient and comfortable compared to traditional methods where a doctor collects the sample. This self-sampling method is as effective as physician-collected samples for detecting high-risk HPV and is highly preferred by women. ^{1 4 6 7 8}

Research Team

Christina Scartozzi, DO

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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

I am overdue for my cervical cancer screening.

I am not at high risk for cervical cancer.

Exclusion Criteria

Incarcerated

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

Pregnant

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. Australia 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. [2017]

3. United States 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. [2022]

4. United States 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? [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. [2017]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. [2022]

8. England 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. [2023]