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

NCT ID: NCT05989464

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2025-02-01

Brief Summary

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.

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.

Conditions

HPV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Self-swab for genital HPV

Intervention Type: DIAGNOSTIC_TEST

Participants will insert a swab in the vagina to collect a sample for HPV testing.

Interventions

Self-swab for genital HPV

Participants will insert a swab in the vagina to collect a sample for HPV testing.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Ann Chang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Chang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

Kalihi Palama

Honolulu, Hawaii, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Riel

Role: CONTACT

jriel@hawaii.edu

(808) 203-6502

Paris Stowers, MD

Role: CONTACT

stowersp@hawaii.edu

Facility Contacts

Ann Chang, MD

Role: primary

annchang@hawaii.edu

808-222-9305

Other Identifiers

2022-00672

Identifier Type: -

Identifier Source: org_study_id