Clinical trial NCT05989464: Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening
Official title: Self-Collected Swabs for Primary Primary Human Papilloma Virus (HPV) Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV
Keywords: hpv
self swab
cervical cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 84
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be identified by their primary care clinician at the Kalihi Palama Health Center.

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.

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

Primary outcomes:
measure: Percentage of swabs with result
timeFrame: Within 1 week of swab collection
measure: Percentage of participants with abnormal result
timeFrame: Within 1 week of swab collection
Secondary outcomes:
measure: Self reported ease of collecting the swab
timeFrame: Immediately after swab is collected
measure: Willingness to collect this swab again in the future
timeFrame: Immediately after swab is collected
measure: Self reported level of worry concerning collecting self swab
timeFrame: Immediately after swab is collected
measure: Knowledge of HPV
timeFrame: Immediately after swab is collected
measure: Knowledge of cervical cancer
timeFrame: Immediately after swab is collected
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kalihi Palama
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Ann Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: