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Adolescent Vaccination in Pharmacies (AVIP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Noel Brewer, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01960088
First received: October 8, 2013
Last updated: May 11, 2014
Last verified: May 2014
  Purpose

The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines, including human papillomavirus (HPV) vaccine. In the first part of the study, we will characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in a national survey. In the second part of the study, we will provide HPV vaccines and other vaccines (Tdap, meningococcal, varicella, influenza) to 100 adolescents in a local community pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems and workflow needed to provide vaccines effectively and safely, characterize parents' and their adolescents' attitudes toward receiving vaccine services in a pharmacy, and characterize pharmacists' attitudes toward providing adolescent vaccine services in a pharmacy.


Condition Intervention
Evaluating Attitudes Toward HPV Vaccinations in Pharmacies
Evaluating the Provision of HPV Vaccines in a Pharmacy
Drug: HPV vaccine

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Building Evidence to Expand Adolescent Vaccination in Pharmacies

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

Primary Outcome Measures:
  • Parents' willingness to get their adolescent children HPV vaccine in pharmacy [ Time Frame: At time of study ] [ Designated as safety issue: No ]
    Outcome is for the national survey of parents.

  • Parents' satisfaction with HPV vaccine vaccine administration in the pharmacy [ Time Frame: At time of vaccine administration ] [ Designated as safety issue: No ]
    Outcome is for demonstration study in a community pharmacy.


Biospecimen Retention:   None Retained

N=1200 anticipated in national study N=100 anticipated in pharmacy demonstration project


Estimated Enrollment: 1300
Study Start Date: August 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescent (11-18 years old) and their parents
National study: there is no intervention Pharmacy demonstration project: HPV vaccine delivery
Drug: HPV vaccine
Other Name: Gardasil

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

National survey: Parents of adolescents ages 11-18. Pharmacy sample: Parents of adolescent boys and girls, ages 11-18 whose families reside in the Chapel Hill area, and their adolescents.

Criteria

NATIONAL SURVEY (probability sample)

Inclusion Criteria:

  • Being a member of the GfK Knowledge Panel
  • Having a child age 11-18.

Exclusion Criteria:

● None

PHARMACY DEMONSTRATION PROJECT (convenience sample)

Inclusion Criteria:

  • Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated
  • Child is with the parent

Exclusion Criteria:

● Being the parent of an adolescent who is immunocompromised, or has other chronic illness, has known anaphylactoid/hypersensitivity reactions to components of HPV vaccine used, or is pregnant or plan to be pregnant within a month of vaccination.

  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 ClinicalTrials.gov identifier: NCT01960088

Contacts
Contact: Megan E Hall, MPH 919.843.8962 meghall@email.unc.edu
Contact: Parth D Shah, PharmD 626.757.1504 pdshah@live.unc.edu

Locations
United States, North Carolina
UNC Gillings School of Global Public Health Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Megan E Hall, MPH    919-843-8962    meghall@email.unc.edu   
Contact: Parth D Shah, PharmD    626.757.1504    pdshah@live.unc.edu   
Principal Investigator: Noel T Brewer, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Noel T Brewer, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Noel Brewer, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01960088     History of Changes
Other Study ID Numbers: 13-2889
Study First Received: October 8, 2013
Last Updated: May 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Adolescent vaccines
HPV vaccine
Pharmacies

ClinicalTrials.gov processed this record on November 25, 2014