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

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

NCT ID: NCT05989464

Condition: HPV

Conditions: Official terms:
Papilloma

Conditions: Keywords:
hpv
self swab
cervical cancer

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Self-swab for genital HPV
Description: Participants will insert a swab in the vagina to collect a sample for HPV testing.
Arm group label: Human Papilloma Virus (HPV) Self swab

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: Female

Gender based: Yes

Minimum age: 25 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Kalihi Palama

Address:
City: Honolulu
Zip: 17460
Country: United States

Status: Recruiting

Contact:
Last name: Ann Chang, MD

Phone: 808-222-9305
Email: annchang@hawaii.edu

Start date: August 8, 2023

Completion date: February 1, 2025

Lead sponsor:
Agency: University of Hawaii
Agency class: Other

Source: University of Hawaii

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05989464