Adolescent Vaccination in Pharmacies

NCT01960088 | Completed

• 1 other identifier: 13-2889
• Study Type: observational
• Target: 1,509
• Locations: 1 country
• Sites: 2

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.

Conditions

Evaluating Attitudes Toward HPV Vaccinations in Pharmacies; Evaluating the Provision of HPV Vaccines in a Pharmacy

Keywords

Adolescent vaccines; HPV vaccine; Pharmacies

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Adolescents and their parents

Pharmacy demonstration project: HPV vaccine delivery

Drug: HPV vaccine

Interventions

HPV vaccine DRUG

Also known as: Gardasil

Adolescents and their parents

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• ● None
• PHARMACY DEMONSTRATION PROJECT (convenience sample)
• Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated
• Child is with the parent
• ● 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Central Pharmacy

Durham, North Carolina, 27704, United States

Location

Triangle Pharmacy

Durham, North Carolina, 27713, United States

Location

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Interventions

Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Noel T Brewer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

US (2)