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A School Health Center Intervention to Increase Adolescent Vaccination

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ClinicalTrials.gov Identifier: NCT01595542
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immunization Program School Health Services HPV Vaccines Behavioral: Modified Vaccine Consent Form Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3417 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A School Health Center Intervention to Increase Adolescent Vaccination
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: School Health
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All students enrolled at target schools

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595542


Locations
United States, North Carolina
Student Health Centers
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
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

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01595542     History of Changes
Other Study ID Numbers: 11-1041
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs