Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A School Health Center Intervention to Increase Adolescent Vaccination

This study has been completed.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill Identifier:
First received: May 8, 2012
Last updated: March 12, 2014
Last verified: March 2014

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 Intervention
Immunization Program
School Health Services
HPV Vaccines
Behavioral: Modified Vaccine Consent Form

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A School Health Center Intervention to Increase Adolescent Vaccination

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from Baseline In The Number of Adolescent Vaccines [ Time Frame: 4 months post intervention ] [ Designated as safety issue: No ]
    Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012.

Secondary Outcome Measures:
  • Number of Returned Consent Forms Authorizing Vaccination [ Time Frame: 4 months post intervention ] [ Designated as safety issue: No ]
    Number of signed and returned consent forms for adolescent vaccines HPV, Tdap, meningococcal conjugate and influenza in the intervention arm.

Enrollment: 3417
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All students enrolled at target schools

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01595542

United States, North Carolina
Student Health Centers
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Noel T Brewer, PhD University of North Carolina Chapel Hill, Department of Health Behavior and Health Education
  More Information

Additional Information:
No publications provided

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01595542     History of Changes
Other Study ID Numbers: 11-1041
Study First Received: May 8, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board processed this record on March 02, 2015