Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments

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.

Study Overview

• Status: Terminated
• Conditions: HPV
• Intervention / Treatment: Device: HPV Self-Sampling Kit (Evalyn Brush)

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy
• Cognitively Impaired
• Incarcerated
• Complete hysterectomy
• History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Sampling Kit; Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within two weeks of the well-woman visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Completed Self-Sampling Kits	The number of participants provided a kit vs. those who completed the sample collection	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.	Within two weeks of the well-woman visit

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Jennifer Moss, PhD, Penn State College of Medicine

Publications and helpful links

General 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.
• Shieh 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.
• U. 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Self-Sampling; Cervical Cancer; HPV; Cancer screening
• Other Study ID Numbers: 14033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes