Human Papilloma VirusNCT06229353
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
An observational study of Human Papilloma Virus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Gardasil 9
- Type of treatment
- Vaccines
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to 30 Jul 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Pre-existing ED-patients in the waiting room who fit the eligibility criteria, as per the chart review which will indicate the participant's age, and if the participant is in good functional capacity, as determined by the ED-attending clinician, and if the participant has no known infection with HPV high risk strain types 6, 11, 16 and 18. Participants running fever or in pain at the time of the initial ED visit and still interested in receiving HPV vaccination, will be offered to come back for HPV vaccination when in good health at a later date.
Who may be able to join
- aged 18-45 years old
- in good functional capacity, as determined by the ED-attending clinician
- no known infection with HPV high risk strain types 6, 11, 16 and 18.
Who cannot join
- will not receive vaccine if participants lack mental clarity and if running a fever or in some pain.
- Patients aged <18 or > 45 years of age.
- Female patients with abnormal HPV results (including those with the high-risk HPV strain types 6, 11, 16, and 18) as determined by a previous PAP smear test or HPV test.
- Female patients who are known to be pregnant.
- Male patients with known cases of HPV-associated infections will also be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0022
About this study
To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).
- Conditions
- Human Papilloma Virus
- Being tested
- Gardasil 9
- Keywords
- Gardasil 9, HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil 9Biological
Also called Human Papillomavirus Vaccine, HPV vaccine
Prevent HPV-associated diseases and cancers
| Study group | Role | What they receive |
|---|---|---|
| Under-immunized Emergency Department adult patients | Adults attending the Emergency Department who are aged 18-45, without previous HPV vaccination history and without previously known infection from HPV high-risk strain, and in good functional capacity.
Eligible participants will receive Gardasil 9 (HPV) vaccination if interested. Receives: Biological: Gardasil 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study participants who receive HPV vaccination at baseline
HPV vaccination will be administered at the time of the study participant's initial visit (baseline)
Measured: Baseline
Number of study participants who receive HPV vaccination at 2 months
Number of study participants receiving dose 2 of the HPV vaccination series 2 months after initial study visit
Measured: 2 months
Number of study participants who receive HPV vaccinations at 6 months
Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Aug 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Why it stopped: Slow pace of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Andrzej Kulczycki, University of Alabama at Birmingham
- Investigators
- Andrzej Kulczycki, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229353
- Sponsor's protocol ID
- IRB-300012035
- Other IDs
- MISP# 101971
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Study data and results will be owned by the University of Alabama at Birmingham (UAB). UAB agrees that all Study data and results generated during the course of the Study may be used fully by Merck for any legitimate business purpose without any additional payments being made to UAB or the PI. Merck agrees not to publish the research data and results generated during the Study until the PI's publication or presentation of the Study results in accordance with Article 9, or 18 months following study completion or termination of this Agreement, whichever occurs first. Merck may disclose the research data and results to health authorities if such disclosure is prior to publication. Merck shall use reasonable efforts to disclose such research data and results confidentially. UAB agrees not to provide any commercial third party with access to or with the right to use the unpublished data or results for any purpose without Merck's permission which shall not be unreasonably withheld.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
- ClinicalTrials.gov ID
- NCT06229353
- Acronym / sponsor ID
- IRB-300012035
- Conditions
- Human Papilloma Virus
- Keywords
- Gardasil 9, HPV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow pace of recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Jan 2024 (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.
To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Under-immunized Emergency Department adult patients | – | Biological: Gardasil 9Adults attending the Emergency Department who are aged 18-45, without previous HPV vaccination history and without previously known infection from HPV high-risk strain, and in good functional capacity. Eligible participants will receive Gardasil 9 (HPV) vaccination if interested. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pre-existing ED-patients in the waiting room who fit the eligibility criteria, as per the chart review which will indicate the participant's age, and if the participant is in good functional capacity, as determined by the ED-attending clinician, and if the participant has no known infection with HPV high risk strain types 6, 11, 16 and 18. Participants running fever or in pain at the time of the initial ED visit and still interested in receiving HPV vaccination, will be offered to come back for HPV vaccination when in good health at a later date.
Key inclusion criteria (3 listed)
- aged 18-45 years old
- in good functional capacity, as determined by the ED-attending clinician
- no known infection with HPV high risk strain types 6, 11, 16 and 18.
Key exclusion criteria (5 listed)
- will not receive vaccine if participants lack mental clarity and if running a fever or in some pain.
- Patients aged <18 or > 45 years of age.
- Female patients with abnormal HPV results (including those with the high-risk HPV strain types 6, 11, 16, and 18) as determined by a previous PAP smear test or HPV test.
- Female patients who are known to be pregnant.
- Male patients with known cases of HPV-associated infections will also be excluded from the study
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 |
|---|---|---|
| Gardasil 9Also: Human Papillomavirus Vaccine, HPV vaccinePrevent HPV-associated diseases and cancers | Biological | Under-immunized Emergency Department adult patients |
Primary outcome
Number of study participants who receive HPV vaccination at baseline
Time frame: Baseline
HPV vaccination will be administered at the time of the study participant's initial visit (baseline)
Number of study participants who receive HPV vaccination at 2 months
Time frame: 2 months
Number of study participants receiving dose 2 of the HPV vaccination series 2 months after initial study visit
Number of study participants who receive HPV vaccinations at 6 months
Time frame: 6 months
Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit
Results and safety
The study was stopped early (reason given: Slow pace of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. All Study data and results will be owned by the University of Alabama at Birmingham (UAB). UAB agrees that all Study data and results generated during the course of the Study may be used fully by Merck for any legitimate business purpose without any additional payments being made to UAB or the PI. Merck agrees not to publish the research data and results generated during the Study until the PI's publication or presentation of the Study results in accordance with Article 9, or 18 months following study completion or termination of this Agreement, whichever occurs first. Merck may disclose the research data and results to health authorities if such disclosure is prior to publication. Merck shall use reasonable efforts to disclose such research data and results confidentially. UAB agrees not to provide any commercial third party with access to or with the right to use the unpublished data or results for any purpose without Merck's permission which shall not be unreasonably withheld.
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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.
Andrzej Kulczycki, PhD principal investigator
University of Alabama at Birmingham
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 Human Papilloma Virus, run by University of Alabama at Birmingham 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Apr 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.
Are results available for this study?
The study was stopped early (reason given: Slow pace of recruitment). Results are not available in the source record.
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?
Number of study participants who receive HPV vaccination at baseline (time frame: Baseline). The study lists 3 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 20 Apr 2026.