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NCT01595542 Clinical Trial

A School Health Center Intervention to Increase Adolescent Vaccination

School Health Services Clinical Trial

Official title:
A School Health Center Intervention to Increase Adolescent Vaccination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01595542
Other study ID # 11-1041
Secondary ID
Status Completed
Phase N/A
First received May 8, 2012
Last updated March 12, 2014
Start date September 2011
Est. completion date February 2012

Study information
Verified date March 2014
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3417
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All students enrolled at target schools

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Modified Vaccine Consent Form
Packet of written immunization materials for parents and students which includes the following: Cover letter Vaccine promotional flyer Vaccine information sheets (one for adolescent vaccination and one for other vaccination) Improved consent form Note advertising a lottery for free movie tickets for returning the consent form Self-addressed stamped envelope

Locations
Country Name City State
United States Student Health Centers Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline In The Number of Adolescent Vaccines Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012. 4 months post intervention No
Secondary Number of Returned Consent Forms Authorizing Vaccination Number of signed and returned consent forms for adolescent vaccines HPV, Tdap, meningococcal conjugate and influenza in the intervention arm. 4 months post intervention No
See also
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Recruiting NCT04451161 - A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy N/A
Completed NCT03178331 - Who Benefit From School Doctors' Health Checks?

External Links