HPVNCT04591977
Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments
A study testing HPV Self-Sampling Kit (Evalyn Brush) in people with HPV, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV
- What is being tested?
- HPV Self-Sampling Kit (Evalyn Brush)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-65 Years
- Penn State Health, Family and Community Medicine, patient attending a well-woman visit
- Able to collect the sample within two weeks of visit
- Female
- Intact cervix
- Speaks, reads, or writes in English
Who cannot join
- Pregnancy
- Cognitively Impaired
- Incarcerated
- Complete hysterectomy
- History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: HPV Self-sampling Among Women at Penn State Hershey Well Women Appointments
This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test and Pap smear results. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative to clinician sampling.
Read the detailed description
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018. Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal. Guidelines recommend cytology and/or human papillomavirus (HPV) testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal.
To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical screening. However, there are concerns about the comparability and acceptability of self-sampling kits. The impact of the proposed project is to compare HPV self-screening results with Pap smear results and clinician-collected HPV tests to ultimately improve the uptake of HPV screening. This study will be conducted in a normal risk population.
Subjects who have an upcoming well-woman appointment will be identified from Penn State Health, Department of Family and Community Medicine, clinic schedules. Clinicians who are a part of the study team will identify these patients two weeks prior to their appointment and send their information to a study coordinator, who will then call these patients to provide more information and assess their interest in participating. Patients who schedule within the two week period or were not contacted by a study team member for any reason will be given a card with general information about the study at their well-woman visit so that these women can contact a study team member if they are interested. A total of 197 participants will be recruited into this study.
Interested participants will be screened for eligibility over the phone and sent a self-sampling kit through the mail with a Summary Explanation of Research form, instructions, and pre-paid mailer to return the kit. Participants may collect their sample two weeks before or after their well-woman visit. A study team member will contact the participants at different time points within the 28 day window to determine whether the sample was collected and to administer the follow-up survey.
- Conditions
- HPV
- Being tested
- HPV Self-Sampling Kit (Evalyn Brush)
- Keywords
- HPV, Cervical Cancer, Self-Sampling, Cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Self-Sampling Kit (Evalyn Brush)Device
The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.
| Study group | Role | What they receive |
|---|---|---|
| Self-Sampling Kit | Experimental | Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. Receives: Device: HPV Self-Sampling Kit (Evalyn Brush) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples
Number of participants whose results of the self-sampling kit were in concordance with the clinician-sampled HPV test and clinician-sampled Pap smear results.
Measured: Within two weeks of the well-woman visit
Secondary outcomes (2)
Number of Completed Self-Sampling Kits
The number of participants provided a kit vs. those who completed the sample collection
Measured: 28 days (two weeks before or after the well-woman visit)
Number of Participants Who Reported Problems With Using Self-Sampling Kits
The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.
Measured: Within two weeks of the well-woman visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Jan 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Why it stopped: low recruitment, preliminary analysis indicates that primary endpoint has been met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who enroll in the study will be asked to complete an HPV self-sampling test in addition to attending their well-woman visit and receiving a clinician-sampled Pap Smear/HPV test. Participants will collect the sample at home and mail it back to the Penn State Health clinical laboratory, where the results will be compared to those obtained from the Pap Smear/HPV test at their clinic appointment. Participants will also complete a follow up survey over the phone after their sample is collected.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Moss, PhD, Milton S. Hershey Medical Center
- Investigators
- Jennifer Moss, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591977
- Sponsor's protocol ID
- 14033
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2020
- Last updated
- 6 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949Shieh Y, Eklund M, Sawaya GF, Black WC, Kramer BS, Esserman LJ. Population-based screening for cancer: hope and hype. Nat Rev Clin Oncol. 2016 Sep;13(9):550-65. doi: 10.1038/nrclinonc.2016.50. Epub 2016 Apr 13.
PubMed 27071351U. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2. Accessed 2018.
Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72. doi: 10.3322/caac.21139. Epub 2012 Mar 14.
PubMed 22422631Wong A, Morgis R, Entenman J, Ramirez SI, Hays AL, Wright TS, Scartozzi CM, Ruffin MT, Moss JL. Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients. Womens Health Rep (New Rochelle). 2024 Mar 13;5(1):259-266. doi: 10.1089/whr.2024.0004. eCollection 2024.
PubMed 38516651
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-sampling Among Women at Penn State Hershey Well Women Appointments
- ClinicalTrials.gov ID
- NCT04591977
- Acronym / sponsor ID
- 14033
- Conditions
- HPV
- Keywords
- HPV, Cervical Cancer, Self-Sampling, Cancer screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment, preliminary analysis indicates that primary endpoint has been met
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 6 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test and Pap smear results. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative to clinician sampling.
Detailed description
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018. Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal. Guidelines recommend cytology and/or human papillomavirus (HPV) testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal.
To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical screening. However, there are concerns about the comparability and acceptability of self-sampling kits. The impact of the proposed project is to compare HPV self-screening results with Pap smear results and clinician-collected HPV tests to ultimately improve the uptake of HPV screening. This study will be conducted in a normal risk population.
Subjects who have an upcoming well-woman appointment will be identified from Penn State Health, Department of Family and Community Medicine, clinic schedules. Clinicians who are a part of the study team will identify these patients two weeks prior to their appointment and send their information to a study coordinator, who will then call these patients to provide more information and assess their interest in participating. Patients who schedule within the two week period or were not contacted by a study team member for any reason will be given a card with general information about the study at their well-woman visit so that these women can contact a study team member if they are interested. A total of 197 participants will be recruited into this study.
Interested participants will be screened for eligibility over the phone and sent a self-sampling kit through the mail with a Summary Explanation of Research form, instructions, and pre-paid mailer to return the kit. Participants may collect their sample two weeks before or after their well-woman visit. A study team member will contact the participants at different time points within the 28 day window to determine whether the sample was collected and to administer the follow-up survey.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who enroll in the study will be asked to complete an HPV self-sampling test in addition to attending their well-woman visit and receiving a clinician-sampled Pap Smear/HPV test. Participants will collect the sample at home and mail it back to the Penn State Health clinical laboratory, where the results will be compared to those obtained from the Pap Smear/HPV test at their clinic appointment. Participants will also complete a follow up survey over the phone after their sample is collected.
| Arm | Type | Receives |
|---|---|---|
| Self-Sampling Kit | Experimental | Device: HPV Self-Sampling Kit (Evalyn Brush)Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 30-65 Years
- Penn State Health, Family and Community Medicine, patient attending a well-woman visit
- Able to collect the sample within two weeks of visit
- Female
- Intact cervix
Key exclusion criteria (5 listed)
- Pregnancy
- Cognitively Impaired
- Incarcerated
- Complete hysterectomy
- History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Self-Sampling Kit (Evalyn Brush)The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home. | Device | Self-Sampling Kit |
Primary outcome
Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples
Time frame: Within two weeks of the well-woman visit
Number of participants whose results of the self-sampling kit were in concordance with the clinician-sampled HPV test and clinician-sampled Pap smear results.
2 secondary outcomes
Number of Completed Self-Sampling Kits
Time frame: 28 days (two weeks before or after the well-woman visit)
Number of Participants Who Reported Problems With Using Self-Sampling Kits
Time frame: Within two weeks of the well-woman visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
- Background: PubMed 27071351Shieh Y, Eklund M, Sawaya GF, Black WC, Kramer BS, Esserman LJ. Population-based screening for cancer: hope and hype. Nat Rev Clin Oncol. 2016 Sep;13(9):550-65. doi: 10.1038/nrclinonc.2016.50. Epub 2016 Apr 13.
- BackgroundU. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2. Accessed 2018.
- Background: PubMed 22422631Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72. doi: 10.3322/caac.21139. Epub 2012 Mar 14.
- Derived from this study: PubMed 38516651Wong A, Morgis R, Entenman J, Ramirez SI, Hays AL, Wright TS, Scartozzi CM, Ruffin MT, Moss JL. Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients. Womens Health Rep (New Rochelle). 2024 Mar 13;5(1):259-266. doi: 10.1089/whr.2024.0004. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Moss, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Self-Sampling Kit (Evalyn Brush) in people with HPV, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples (time frame: Within two weeks of the well-woman visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591977, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.