A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates

NCT ID: NCT01526551

Last Updated: 2015-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

935 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Schools

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.

Group Type EXPERIMENTAL

HPV Vaccine and HPV-related Health Education

Intervention Type OTHER

Increased education of HPV-related diseases and HPV vaccine

Reduction of barriers

Intervention Type OTHER

Eliminate structural and financial barriers to being vaccinated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HPV Vaccine and HPV-related Health Education

Increased education of HPV-related diseases and HPV vaccine

Intervention Type OTHER

Reduction of barriers

Eliminate structural and financial barriers to being vaccinated

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

School based delivery of HPV vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must have not completed three dose series of HPV vaccine
* Must be a student at Wayne County or Monticello High School in KY

Exclusion Criteria

* Completed three dose series
* Pregnant
* Contraindication to vaccine ingredients
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Lake Cumberland District Health Department

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine Weyman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lake Cumberland District Health Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Monticello High School

Monticello, Kentucky, United States

Site Status

Wayne County High School

Monticello, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LCDHD-12-HPV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Video to Promote HPV Vaccination
NCT02196454 COMPLETED NA
PREVENT HPV -Related Cancers Trial
NCT07217145 RECRUITING NA
AFIX to Improve HPV Vaccination
NCT02370459 COMPLETED NA