Adolescent Vaccination in Pharmacies (AVIP)

Building Evidence to Expand Adolescent Vaccination in Pharmacies

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.

Study Overview

• Status: Completed
• Conditions: Evaluating Attitudes Toward HPV Vaccinations in Pharmacies; Evaluating the Provision of HPV Vaccines in a Pharmacy
• Intervention / Treatment: Drug: HPV vaccine

• Study Type: Observational
• Enrollment (Actual): 1509

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Central Pharmacy
    • Durham, North Carolina, United States, 27713
      • Triangle Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents and their parents; Pharmacy demonstration project: HPV vaccine delivery	Drug: HPV vaccine; Other Names: Gardasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents' willingness to get their adolescent children HPV vaccine in pharmacy	Outcome is for the national survey of parents.	At time of study
Parents' satisfaction with HPV vaccine vaccine administration in the pharmacy	Outcome is for demonstration study in a community pharmacy.	At time of vaccine administration

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Noel T Brewer, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: HPV vaccine; Pharmacies; Adolescent vaccines
• Other Study ID Numbers: 13-2889