Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening

Self-Collected Swabs for Primary Primary Human Papilloma Virus (HPV) Screening

In this study, the investigators will assess whether implementing a self-swab protocol for primary Human Papilloma Virus (HPV) testing is an effective method to increase cervical cancer screening in a sample of unscreened women in Hawaii. The findings of this study may support adoption of HPV self swab protocols both at Kalihi Palama Health Center (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.

Study Overview

• Status: Recruiting
• Conditions: HPV
• Intervention / Treatment: Diagnostic test: Self-swab for genital HPV

Detailed Description

Cervical cancer is the fourth most common cancer worldwide. In the United States, the majority of cervical cancer diagnoses are made in individuals who have not been adequately screened. Cervical cancer prevention relies on adequate screening using one of three methods: pap smear cytology, Human Papilloma Virus (HPV) testing alone, or a combination of these two tests. These screening tests are performed by clinicians comfortable performing a pelvic exam, most commonly a women's health provider. Currently, less than 60% of individuals with an indication for cervical cancer screening in the Kalihi Palama Health Center (KPHC) are up-to-date on their cervical cancer screening test. Even patients who regularly see their primary care provider (PCP) can face major barriers to attending an appointment with a women's health provider. These barriers include practical issues such as inability to take time off, cost concerns, and lack of transportation. Emotional barriers include embarrassment, lack of privacy, and discomfort associated with the test.

Self-collected swabs for HPV testing is a proven strategy for populations with low screening rates. Prior studies have demonstrated increased screening rates for transgender men, African American women in the Mississippi Delta, and Women From Appalachian Ohio. Studies also reported patient evaluations of the self-sampling to be comfortable, convenient, and user-friendly; and one study found a majority preference of self-sampling over practitioner-sampling for the next screening.

Self-collected samples have also demonstrated good concordance with practitioner-collected cervical samples, as seen in multiple studies. The multiple benefits of self-swabbing without compromising screening accuracy enables the HPV self swab protocol to be an effective alternative for under screened populations. In fact, multiple countries have adopted national guidelines for self-sampled HPV screening for either under screened populations or as primary screening for all women, and more countries are piloting self-sampling to date.

In this study, the investigators will assess whether implementing a self-swab protocol for primary HPV testing is an effective method to increase cervical cancer screening in a sample of unscreened women in Hawaii. The findings of this study may support adoption of HSS protocols both at (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Jonathan Riel; Phone Number: (808) 203-6502; Email: jriel@hawaii.edu
• Study Contact Backup: Name: Paris Stowers, MD; Email: stowersp@hawaii.edu

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 17460
      • Recruiting
      • Kalihi Palama
      • Contact: Ann Chang, MD; Phone Number: 808-222-9305; Email: annchang@hawaii.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be identified by their primary care clinician at the Kalihi Palama Health Center.

Description

Inclusion Criteria:

• Age of 25 years or older
• Have a cervix
• Have an indication for cervical cancer screening per Accreditation Council for Continuing Medical Education (ASCCP) guidelines
• Have been previously referred to women's health in the past 5 years or subjects have declined a women's health referral.
• Subjects must not have been seen in women's health clinic since referral was placed

Exclusion Criteria:

• Subjects unable to consent in one of the following languages: English, Chuukese, or Marshallese
• Subjects with known history of cervical cancer
• Subjects that are currently pregnant or within 3 months of giving birth

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Human Papilloma Virus (HPV) Self swab; Enrolled participants will be instructed to perform a self swab for genital Human Papilloma Virus (HPV) infection. Additionally, a short survey will be administered to collect demographic information, evaluate knowledge of HPV/cervical cancer, and assess acceptability of HPV self swab.	Diagnostic test: Self-swab for genital HPV; Participants will insert a swab in the vagina to collect a sample for HPV testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of swabs with result	Percentage of swabs with result	Within 1 week of swab collection
Percentage of participants with abnormal result	Percentage of participants with abnormal result	Within 1 week of swab collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self reported ease of collecting the swab	Self reported ease of collecting the swab	Immediately after swab is collected
Willingness to collect this swab again in the future	Participants will be asked via written questionnaire: "Would you be willing to self collect this swab again in the future?"	Immediately after swab is collected
Self reported level of worry concerning collecting self swab	Self reported level of worry concerning collecting self swab	Immediately after swab is collected
Knowledge of HPV	Participants will be asked a true or false question concerning the prevalence of HPV in the United States on a written questionnaire.	Immediately after swab is collected
Knowledge of cervical cancer	Participants will be asked a true or false question concerning the prevalence of cervical cancer in the United States on a written questionnaire.	Immediately after swab is collected

Collaborators and Investigators

• Sponsor: University of Hawaii
• Investigators: Principal Investigator: Ann Chang, MD, University of Hawaii

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cervical cancer; hpv; self swab
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: 2022-00672

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
• product manufactured in and exported from the U.S.: No