At-Home HPV Self-Sampling for Cervical Cancer Screening
Recruiting in Palo Alto (17 mi)
Overseen byChristina Scartozzi, DO
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Pregnant, Incarcerated, Compromised immune, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
14678Eligibility 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
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Requested self-sampled HPV testExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Health St. Joseph'sReading, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
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]Primary screening using high-risk human papillomavirus (hrHPV) detection has been suggested as a way of improving cervical cancer prevention. Women currently not attending screening (nonresponders) are more likely to participate when given the opportunity of self-sampling for hrHPV testing. The Evalyn Brush is a new cervicovaginal self-sampling device, developed specifically to meet women's demands, which is user-friendly and easy to use. The aims of this study were to investigate agreement of hrHPV detection by two PCR methods between the Evalyn Brush and physician-obtained samples and to study women's acceptance of this self-sampling device. Each of 134 women visiting the gynecology outpatient clinic collected a self-obtained sample (self-sample) and completed a questionnaire. The brush was stored dry. After self-sampling, a trained physician obtained a conventional cervical cytology specimen in ThinPrep medium. HrHPV detection was performed using the SPF(10)-DEIA-LiPA(25) and GP5+/6+-LQ-test. The overall agreement for hrHPV detection using SPF(10)-DEIA-LiPA(25) between the self-sample and the physician-taken sample was 85.8% (kappa value, 0.715; 95% confidence interval [CI], 0.597 to 0.843; P = 1.000). The overall agreement for hrHPV detection using GP5+/6+-LQ between the self-sample and the physician-taken sample was 86.6% (kappa value, 0.725; 95% CI, 0.607 to 0.843; P = 0.815). Ninety-eight percent of the women rated their experience as good to excellent. Moreover, 95% of women preferred self-sampling to physician sampling. Self-sampling using the dry Evalyn Brush system is as good as a physician-taken sample for hrHPV detection and is highly acceptable to women. To validate this self-sampling device for clinical use, a large screening cohort should be studied.
Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. [2017]To evaluate the analytical and clinical effectiveness of cervicovaginal self-sampling with a dry sampling device (Evalyn Brush) for high-risk human papillomavirus (hr-HPV) testing and detection of cervical disease.
Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. [2022]We evaluated the effect of offering brush-based vaginal self-sampling for high-risk human papillomavirus (hrHPV) testing to non-attendees of the cervical screening program on response rate, compliance to follow-up and cervical intraepithelial neoplasia grade 2 or 3 (CIN2+/CIN3+) yield. In addition, concordance of hrHPV test results between physician-taken cervical scrapes and vaginal self-samples was determined. A total of 26,409 nonattending women were randomly assigned to receive a vaginal brush device for hrHPV testing by Hybrid Capture-2 method (i.e., self-sampling group, n = 26,145) or a reinvitation for regular cytology-based screening (i.e., recall control group, n = 264). hrHPV-positive self-sampling responders were invited for a physician-taken scrape for cytology and blinded hrHPV testing. If cytology was abnormal, women were referred for colposcopy. Response rate in the self-sampling group was significantly increased compared to the recall control group (30.8% versus 6.5%; p
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]Self-sampling to test for high risk human papilloma virus (HPV) is becoming an increasingly important component of cervical cancer screening. The aim of this observational study is to examine how women treated for high-grade cervical intraepithelial neoplasia (CIN) view HPV self-sampling.
Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. [2017]Self-sampling for HPV as part of primary screening is a well-tolerated method for women not attending organized Pap smear screening and could increase coverage of cervical cancer screening.
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]Home-based self-sampling for human papillomavirus (HPV) testing may be an alternative for women not attending clinic-based cervical cancer screening.
Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. [2022]Self sampling is considered an adjuvant tool to facilitate the participation of women in cervical cancer screening programmes. This study aimed to evaluate whether cervicovaginal lavage could be an alternative for the cervical smear in cytology and human papillomavirus (HPV) testing and to assess the acceptance of the self sampling device by women.
Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening: a randomised controlled trial. [2023]HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer.