Adolescent Vaccination in Pharmacies (AVIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960088
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : April 24, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment
Evaluating Attitudes Toward HPV Vaccinations in Pharmacies Evaluating the Provision of HPV Vaccines in a Pharmacy Drug: HPV vaccine

Study Type : Observational
Actual Enrollment : 1509 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Building Evidence to Expand Adolescent Vaccination in Pharmacies
Study Start Date : July 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Group/Cohort Intervention/treatment
Adolescents and their parents
Pharmacy demonstration project: HPV vaccine delivery
Drug: HPV vaccine
Other Name: Gardasil

Primary Outcome Measures :
  1. Parents' willingness to get their adolescent children HPV vaccine in pharmacy [ Time Frame: At time of study ]
    Outcome is for the national survey of parents.

  2. Parents' satisfaction with HPV vaccine vaccine administration in the pharmacy [ Time Frame: At time of vaccine administration ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

NATIONAL SURVEY (probability sample)

Inclusion Criteria:

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

Exclusion Criteria:

● None


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960088

United States, North Carolina
Central Pharmacy
Durham, North Carolina, United States, 27704
Triangle Pharmacy
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Principal Investigator: Noel T Brewer, PhD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01960088     History of Changes
Other Study ID Numbers: 13-2889
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs