NCT01595542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,417

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

May 8, 2012

Last Update Submit

March 12, 2014

Conditions

Immunization ProgramSchool Health ServicesHPV Vaccines

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Returned Consent Forms Authorizing Vaccination

    4 months post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Parents served by experimental school sites received intervention packets including modified vaccine consent form

Behavioral: Modified Vaccine Consent Form

Control

NO INTERVENTION

Did not receive intervention materials

Interventions

Modified Vaccine Consent FormBEHAVIORAL

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All students enrolled at target schools

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Student Health Centers

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

  • Noel T Brewer, PhD

    University of North Carolina Chapel Hill, Department of Health Behavior and Health Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)