Human PapillomavirusNCT01526551
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
A study testing HPV Vaccine and HPV-related Health Education and Reduction of barriers in people with Human Papillomavirus, run by Lake Cumberland District Health Department at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- HPV Vaccine and HPV-related Health Education and Reduction of barriers
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 935 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must have not completed three dose series of HPV vaccine
- Must be a student at Wayne County or Monticello High School in KY
Who cannot join
- Completed three dose series
- Pregnant
- Contraindication to vaccine ingredients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Monticello High School
Monticello, Kentucky, 42633
Wayne County High School
Monticello, Kentucky, 42633
About this study
Official title: A Study to Compare the Impact of a School Based HPV Vaccination Program on Vaccination Uptake and Completion Rates Among High School Students in Rural, Southeastern Kentucky
The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.
Read the detailed description
The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.
- Conditions
- Human Papillomavirus
- Being tested
- HPV Vaccine and HPV-related Health Education, Reduction of barriers
- Keywords
- Human Papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine and HPV-related Health EducationOther
Increased education of HPV-related diseases and HPV vaccine
Reduction of barriersOther
Also called School based delivery of HPV vaccine
Eliminate structural and financial barriers to being vaccinated
| Study group | Role | What they receive |
|---|---|---|
| Intervention Schools | Experimental | High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV Vaccine and HPV-related Health Education and Reduction of barriers to being vaccinated. Receives: Other: HPV Vaccine and HPV-related Health Education; Other: Reduction of barriers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program
Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program
Measured: August 2012-June 2013
Number of Students Who Completed HPV Vaccination as a Result of the School-based Program
Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program
Measured: August 2012 -- June 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human PapillomavirusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lake Cumberland District Health Department
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Christine Weyman, M.D., Principal investigator, Lake Cumberland District Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526551
- Sponsor's protocol ID
- LCDHD-12-HPV
- Status last verified
- Feb 2015
- First submitted
- 22 Dec 2011
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Impact of a School Based HPV Vaccination Program on Vaccination Uptake and Completion Rates Among High School Students in Rural, Southeastern Kentucky
- ClinicalTrials.gov ID
- NCT01526551
- Acronym / sponsor ID
- LCDHD-12-HPV
- Conditions
- Human Papillomavirus
- Keywords
- Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 935 participants (actual)
- Lead sponsor
- Lake Cumberland District Health DepartmentUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.
Detailed description
The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Schools | Experimental | Other: HPV Vaccine and HPV-related Health Education, Other: Reduction of barriersHigh school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV Vaccine and HPV-related Health Education and Reduction of barriers to being vaccinated. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Must have not completed three dose series of HPV vaccine
- Must be a student at Wayne County or Monticello High School in KY
Key exclusion criteria (3 listed)
- Completed three dose series
- Pregnant
- Contraindication to vaccine ingredients
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 |
|---|---|---|
| HPV Vaccine and HPV-related Health EducationIncreased education of HPV-related diseases and HPV vaccine | Other | Intervention Schools |
| Reduction of barriersAlso: School based delivery of HPV vaccineEliminate structural and financial barriers to being vaccinated | Other | Intervention Schools |
Primary outcome
Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program
Time frame: August 2012-June 2013
Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program
Number of Students Who Completed HPV Vaccination as a Result of the School-based Program
Time frame: August 2012 -- June 2013
Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christine Weyman, M.D. principal investigator
Lake Cumberland District Health Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Vaccine and HPV-related Health Education and Reduction of barriers in people with Human Papillomavirus, run by Lake Cumberland District Health Department at 2 sites 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 2 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: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 6 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program (time frame: August 2012-June 2013). 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 6 Mar 2015.