A School Health Center Intervention to Increase Adolescent Vaccination

March 12, 2014 updated by: University of North Carolina, Chapel Hill
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Student Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All students enrolled at target schools

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Parents served by experimental school sites received intervention packets including modified vaccine consent form
Behavioral: Modified Vaccine Consent Form

Packet of written immunization materials for parents and students which includes the following:

  1. Cover letter
  2. Vaccine promotional flyer
  3. Vaccine information sheets (one for adolescent vaccination and one for other vaccination)
  4. Improved consent form
  5. Note advertising a lottery for free movie tickets for returning the consent form
  6. Self-addressed stamped envelope
No Intervention: Control
Did not receive intervention materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline In The Number of Adolescent Vaccines
Time Frame: 4 months post intervention
Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012.
4 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Returned Consent Forms Authorizing Vaccination
Time Frame: 4 months post intervention
Number of signed and returned consent forms for adolescent vaccines HPV, Tdap, meningococcal conjugate and influenza in the intervention arm.
4 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Noel T Brewer, PhD, University of North Carolina Chapel Hill, Department of Health Behavior and Health Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 11-1041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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