School Located Adolescent Vaccination Study

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: School Located Vaccine Program

Treatments: Behavioral: School Located Vaccine (SLV) Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01719679

08-0204

Details and patient eligibility

About

The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. The likelihood of vaccination for diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a comprehensive school-based immunization program will be significantly higher than that of students enrolled in schools without a school-based immunization program.

Enrollment: 2,000 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
• students who appear to be in need of one or more immunizations of interest at the beginning of the school year
• students enrolled in school by October 1st registration deadline will be included in the analysis

Exclusion criteria

• students who appear to have had all immunizations of interest at the beginning of the school year
• students enrolled after the October 1 school registration deadline will be excluded from the analysis
• students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

School Located Vaccine (SLV) Program

Experimental group

Description:

A vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools

Treatment:

Behavioral: School Located Vaccine (SLV) Program

no School Located Vaccine (SLV) Program

No Intervention group

Description:

Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program.