Evaluating Attitudes Toward HPV Vaccinations in PharmaciesAVIPNCT01960088
Adolescent Vaccination in Pharmacies
An observational study of Evaluating Attitudes Toward HPV Vaccinations in Pharmacies and Evaluating the Provision of HPV Vaccines in a Pharmacy, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluating Attitudes Toward HPV Vaccinations in Pharmacies, Evaluating the Provision of HPV Vaccines in a Pharmacy
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines
- How many people
- 1,509 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Being a member of the GfK Knowledge Panel
- Having a child age 11-18.
- Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated
- Child is with the parent
Who cannot join
- ● None
- PHARMACY DEMONSTRATION PROJECT (convenience sample)
- ● 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Pharmacy
Durham, North Carolina, 27704
Triangle Pharmacy
Durham, North Carolina, 27713
About this study
Official title: 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.
- Conditions
- Evaluating Attitudes Toward HPV Vaccinations in Pharmacies, Evaluating the Provision of HPV Vaccines in a Pharmacy
- Being tested
- HPV vaccine
- Keywords
- Adolescent vaccines, HPV vaccine, Pharmacies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineDrug
Also called Gardasil
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and their parents | Pharmacy demonstration project: HPV vaccine delivery Receives: Drug: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' willingness to get their adolescent children HPV vaccine in pharmacy
Outcome is for the national survey of parents.
Measured: At time of study
Parents' satisfaction with HPV vaccine vaccine administration in the pharmacy
Outcome is for demonstration study in a community pharmacy.
Measured: At time of vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJul 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating Attitudes Toward HPV Vaccinations in PharmaciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960088
- Sponsor's protocol ID
- 13-2889
- Acronym
- AVIP
- Status last verified
- Apr 2018
- First submitted
- 8 Oct 2013
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Evidence to Expand Adolescent Vaccination in Pharmacies
- ClinicalTrials.gov ID
- NCT01960088
- Acronym / sponsor ID
- AVIP / 13-2889
- Conditions
- Evaluating Attitudes Toward HPV Vaccinations in Pharmacies, Evaluating the Provision of HPV Vaccines in a Pharmacy
- Keywords
- Adolescent vaccines, HPV vaccine, Pharmacies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,509 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents and their parents | – | Drug: HPV vaccinePharmacy demonstration project: HPV vaccine delivery |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- Being a member of the GfK Knowledge Panel
- Having a child age 11-18.
- Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated
- Child is with the parent
Key exclusion criteria (3 listed)
- ● None
- PHARMACY DEMONSTRATION PROJECT (convenience sample)
- ● 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccineAlso: Gardasil | Drug | Adolescents and their parents |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel T Brewer, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluating Attitudes Toward HPV Vaccinations in Pharmacies and Evaluating the Provision of HPV Vaccines in a Pharmacy, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' willingness to get their adolescent children HPV vaccine in pharmacy (time frame: At time of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.