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

NCT04591977 | Terminated Results FDA Device

• 1 other identifier: 14033
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HPV

Keywords

HPV; Cervical Cancer; Self-Sampling; Cancer screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Completed Self-Sampling Kits

  28 days (two weeks before or after the well-woman visit)

• Number of Participants Who Reported Problems With Using Self-Sampling Kits

  Within two weeks of the well-woman visit

Study Arms (1)

Self-Sampling Kit

EXPERIMENTAL

Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening.

Device: HPV Self-Sampling Kit (Evalyn Brush)

Interventions

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.

Self-Sampling Kit

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

• 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.

  PMID: 29313949 BACKGROUND

• 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.

  PMID: 27071351 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22422631 BACKGROUND

• Wong 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.

  PMID: 38516651 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

small sample size due to slow participant accrual, exclusion of patients who do not seek care (population most likely to benefit from self-sampling)

Results Point of Contact

• Title: Jennifer L. Moss, PhD
• Organization: Pennsylvania State University College of Medicine

jmoss1@pennstatehealth.psu.edu

7175310003

Study Officials

• Jennifer Moss, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: January 7, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)