HPVNCT05989464
Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening
An observational study of HPV, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV
- What is being tested?
- Self-swab for genital HPV
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible participants will be identified by their primary care clinician at the Kalihi Palama Health Center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Paris Stowers, MD contact
United States1 site, 1 recruiting
- Recruiting
Kalihi Palama
Honolulu, Hawaii, 17460
Ann Chang, MD, 808-222-9305, annchang@hawaii.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Self-swab for genital HPV
- Keywords
- hpv, self swab, cervical cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-swab for genital HPVDiagnostic test
Participants will insert a swab in the vagina to collect a sample for HPV testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Self-swab for genital HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of swabs with result
Percentage of swabs with result
Measured: Within 1 week of swab collection
Percentage of participants with abnormal result
Percentage of participants with abnormal result
Measured: Within 1 week of swab collection
Secondary outcomes (5)
Self reported ease of collecting the swab
Self reported ease of collecting the swab
Measured: 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?"
Measured: Immediately after swab is collected
Self reported level of worry concerning collecting self swab
Self reported level of worry concerning collecting self swab
Measured: 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.
Measured: 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.
Measured: Immediately after swab is collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Chang, University of Hawaii
- Investigators
- Ann Chang, MD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989464
- Sponsor's protocol ID
- 2022-00672
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Collected Swabs for Primary Primary Human Papilloma Virus (HPV) Screening
- ClinicalTrials.gov ID
- NCT05989464
- Acronym / sponsor ID
- 2022-00672
- Conditions
- HPV
- Keywords
- hpv, self swab, cervical cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Papilloma Virus (HPV) Self swab | – | Diagnostic Test: Self-swab for genital HPVEnrolled 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be identified by their primary care clinician at the Kalihi Palama Health Center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-swab for genital HPVParticipants will insert a swab in the vagina to collect a sample for HPV testing. | Diagnostic test | Human Papilloma Virus (HPV) Self swab |
Primary outcome
Percentage of swabs with result
Time frame: Within 1 week of swab collection
Percentage of swabs with result
Percentage of participants with abnormal result
Time frame: Within 1 week of swab collection
Percentage of participants with abnormal result
5 secondary outcomes
Self reported ease of collecting the swab
Time frame: Immediately after swab is collected
Willingness to collect this swab again in the future
Time frame: Immediately after swab is collected
Self reported level of worry concerning collecting self swab
Time frame: Immediately after swab is collected
Knowledge of HPV
Time frame: Immediately after swab is collected
Knowledge of cervical cancer
Time frame: Immediately after swab is collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paris Stowers, MD contact
Ann Chang, MD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Riel ((808) 203-6502, jriel@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of swabs with result (time frame: Within 1 week of swab collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.