Human Papillomavirus InfectionPhase 4NCT04474821
HPV Educational Intervention to Increase Acceptance and Completion of Free HPV Vaccination Among Underserved Adults
A Phase 4 study testing Educational Intervention and Survey Administration in people with Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase IV trial examines the impact of an education program on the human papilloma virus (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination program in underserved adult patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
- What is being tested?
- Educational Intervention and Survey Administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 22 Dec 2025
- Phase
- Phase 4
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female adults patients seen at Volunteers in Medicine ages 18-45 years of age who read and understand English or Spanish
Who cannot join
- Children (under 18 years of age)
- Individuals who had previously received any dose of HPV vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)
This phase IV trial examines the impact of an education program on the human papilloma virus (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination program in underserved adult patients. Participating in the HPV educational program may increase the HPV vaccination rates among low income uninsured adult patients and ultimately prevent HPV related cancers.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the acceptability and completion rates of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.
II. Determine if an education program on HPV vaccination increases the acceptability of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.
III. Determine the baseline prevalence of HPV vaccination completion rates among VIM patients age 18-45.
IV. Determine if there are differences in acceptance and completion rates of HPV vaccination, among VIM patients of different sex, age (18-26 versus [vs] 27-45), ethnicity or race, following an education program on HPV as part of this protocol participation.
VI. Assessing possible barriers for vaccine series completion. VII. Determine if follow up intervention increases completion rate of free HPV vaccine series within 9 months.
OUTLINE:
Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.
- Being tested
- Educational Intervention, Survey Administration
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials on HPV
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (HPV educational program) | Experimental | Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine. Receives: Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and completion rates of free HPV vaccination
Measured: Up to 2 years
Secondary outcomes (1)
Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start19 Oct 2020
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Colon-Otero, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474821
- Sponsor's protocol ID
- 18-010455
- Other IDs
- NCI-2020-04723, 18-010455
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)
- ClinicalTrials.gov ID
- NCT04474821
- Acronym / sponsor ID
- 18-010455
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 17 Jul 2020 (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.
This phase IV trial examines the impact of an education program on the human papilloma virus (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination program in underserved adult patients. Participating in the HPV educational program may increase the HPV vaccination rates among low income uninsured adult patients and ultimately prevent HPV related cancers.
Detailed description
PRIMARY OBJECTIVES:
- Determine the acceptability and completion rates of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.
II. Determine if an education program on HPV vaccination increases the acceptability of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.
III. Determine the baseline prevalence of HPV vaccination completion rates among VIM patients age 18-45.
IV. Determine if there are differences in acceptance and completion rates of HPV vaccination, among VIM patients of different sex, age (18-26 versus [vs] 27-45), ethnicity or race, following an education program on HPV as part of this protocol participation.
VI. Assessing possible barriers for vaccine series completion. VII. Determine if follow up intervention increases completion rate of free HPV vaccine series within 9 months.
OUTLINE:
Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (HPV educational program) | Experimental | Other: Educational Intervention, Other: Survey AdministrationPatients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female adults patients seen at Volunteers in Medicine ages 18-45 years of age who read and understand English or Spanish
Key exclusion criteria (2 listed)
- Children (under 18 years of age)
- Individuals who had previously received any dose of HPV vaccine
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials on HPV | Other | Prevention (HPV educational program) |
| Survey AdministrationAncillary studies | Other | Prevention (HPV educational program) |
Primary outcome
Acceptance and completion rates of free HPV vaccination
Time frame: Up to 2 years
1 secondary outcome
Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Gerardo Colon-Otero, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Educational Intervention and Survey Administration in people with Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, run by Mayo Clinic 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jan 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and completion rates of free HPV vaccination (time frame: Up to 2 years). 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 12 Jan 2026.