HPV VaccinationNCT06247124
OPERATION WIPE OUT: Multi-Channel Communication Campaign to Promote HPV Vaccination in Chambers County, Alabama
A study testing multi-channel communication campaign to promote HPV vaccination in people with HPV Vaccination, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination
- What is being tested?
- multi-channel communication campaign to promote HPV vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school students enrolled in the Health Science Program at the Chambers County School District, Alabama
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Chambers County School District
Lafayette, Alabama, 36862
About this study
The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level obtained Alabama Department of Public Health Vaccination Registry (ImmPRINT). Additionally, treatment fidelity and scalability assessments will be conducted to inform sustainability efforts.
Read the detailed description
The human papillomavirus (HPV) is the most common sexually transmitted infection in the U.S., and it has been well established that high-risk HPV infection is causally related to cervical, vaginal, vulvar, anal, and oropharyngeal cancer. This discovery led to the development of a safe and effective preventive vaccine that is available in U.S. through most health insurances or federally-funded programs. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. While the plan is comprehensive and outlines specific evidence-based strategies to promote HPV vaccination along with cervical cancer screening/follow-up, the evidence on multi-channel communication interventions (besides provider-focused interventions) to promote HPV vaccination uptake at the population level is scarce, and the results are mixed. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). Key components will include: (a) capacity building of high school students providing them with knowledge, skills, and support to develop and implement the campaign; (b) engagement of parents, teachers, school nurses, and school administrators); and (c) school-based vaccination. The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level. Alabama has a robust vaccination registry managed by Alabama Department of Public Health (ImmPRINT). Additionally, treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) will be conducted to inform sustainability efforts.
- Conditions
- HPV Vaccination
- Being tested
- multi-channel communication campaign to promote HPV vaccination
- Keywords
- HPV vaccination, Schools, High school students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-channel communication campaign to promote HPV vaccinationBehavioural
High school students will develop, implement, and evaluate a multi-channel communication campaign to promote HPV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccination | Other | Multi-channel campaign to promote HPV vaccination Receives: Behavioral: multi-channel communication campaign to promote HPV vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccination Uptake at the School Level
HPV vaccination uptake at the school level
Measured: One year
Secondary outcomes (1)
Knowledge and confidence among the high school students
Pre- and post-training level of knowledge and confidence among the high
Measured: 6monhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Nov 2023
- Primary completion20 Jun 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccinationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- high school students are enrolled as research participants to develop a multi-channel campaign to promote HPV vaccination
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Isabel Scarinci, University of Alabama at Birmingham
- Investigators
- Isabel Scarinci, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247124
- Sponsor's protocol ID
- IRB3000011735
- Other IDs
- P30CA013148
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are only have 60 minors enrolled in the research. Thus, there is a need to keep confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPERATION WIPE OUT: Multi-Channel Communication Campaign to Promote HPV Vaccination in Chambers County, Alabama
- ClinicalTrials.gov ID
- NCT06247124
- Acronym / sponsor ID
- IRB3000011735
- Conditions
- HPV Vaccination
- Keywords
- HPV vaccination, Schools, High school students
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Feb 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.
The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level obtained Alabama Department of Public Health Vaccination Registry (ImmPRINT). Additionally, treatment fidelity and scalability assessments will be conducted to inform sustainability efforts.
Detailed description
The human papillomavirus (HPV) is the most common sexually transmitted infection in the U.S., and it has been well established that high-risk HPV infection is causally related to cervical, vaginal, vulvar, anal, and oropharyngeal cancer. This discovery led to the development of a safe and effective preventive vaccine that is available in U.S. through most health insurances or federally-funded programs. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. While the plan is comprehensive and outlines specific evidence-based strategies to promote HPV vaccination along with cervical cancer screening/follow-up, the evidence on multi-channel communication interventions (besides provider-focused interventions) to promote HPV vaccination uptake at the population level is scarce, and the results are mixed. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). Key components will include: (a) capacity building of high school students providing them with knowledge, skills, and support to develop and implement the campaign; (b) engagement of parents, teachers, school nurses, and school administrators); and (c) school-based vaccination. The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level. Alabama has a robust vaccination registry managed by Alabama Department of Public Health (ImmPRINT). Additionally, treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) will be conducted to inform sustainability efforts.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- high school students are enrolled as research participants to develop a multi-channel campaign to promote HPV vaccination
| Arm | Type | Receives |
|---|---|---|
| HPV vaccination | Other | Behavioral: multi-channel communication campaign to promote HPV vaccinationMulti-channel campaign to promote HPV vaccination |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school students enrolled in the Health Science Program at the Chambers County School District, Alabama
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| multi-channel communication campaign to promote HPV vaccinationHigh school students will develop, implement, and evaluate a multi-channel communication campaign to promote HPV vaccination. | Behavioural | HPV vaccination |
Primary outcome
HPV Vaccination Uptake at the School Level
Time frame: One year
HPV vaccination uptake at the school level
1 secondary outcome
Knowledge and confidence among the high school students
Time frame: 6monhs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. There are only have 60 minors enrolled in the research. Thus, there is a need to keep confidentiality
Related trials for HPV Vaccination
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Active, not recruitingPhase 4
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
HPV Infection
Active, not recruiting
Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care
Human Papillomavirus Infection
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
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.
Isabel Scarinci, 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?
A study testing multi-channel communication campaign to promote HPV vaccination in people with HPV Vaccination, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
HPV Vaccination Uptake at the School Level (time frame: One year). 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 8 Oct 2026.