Adolescent Vaccination in Pharmacies (AVIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01960088
First received: October 8, 2013
Last updated: February 25, 2016
Last verified: February 2016
  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 200 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: 1704
Study Start Date: July 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents and their parents
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: Parth D Shah, PharmD 626.757.1504 pdshah@live.unc.edu

Locations
United States, North Carolina
Central Pharmacy Recruiting
Durham, North Carolina, United States, 27704
Contact: Parth D Shah, PharmD    626-757-1504    pdshah@live.unc.edu   
Principal Investigator: Noel T Brewer, PhD         
Triangle Pharmacy Recruiting
Durham, North Carolina, United States, 27713
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

Responsible Party: 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: February 25, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016