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N/A N=4,173 Randomized Prevention

4 Pillars Toolkit for Adolescent Vaccination

Adolescent HPV Vaccine · Adolescent Influenza Vaccine

Enrolled (actual)
4,173
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age — 13.7; 10.1; 7.8; 5.7 percent change in vaccination rates — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
4 Pillars Toolkit (Behavioral)
Age
Pediatric · 11+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age
13.7; 10.1; 7.8; 5.7 <0.001 sig
PRIMARY
Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age
14.8; 15.8; 11.6; 10.8 0.001 sig

Summary

The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).

Eligibility Criteria

Inclusion Criteria

  • For clinical sites: inclusion criterion includes
  • an appropriate adolescent population: e.g., adolescents aged 11 to 17 years
  • currently using an EMR
  • having and keeping immunization data within a EMR or registry.

Exclusion Criteria

  • For clinical sites: the exclusion criteria is consistent SOP use for the vaccines being studied or known much higher than average immunization rates.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02165722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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