- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660331
Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study (PROMOTE)
PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
Study Overview
Status
Conditions
Detailed Description
OUTLINE:
AIM 1: Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.
AIM 2: Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60-minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes.
Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics.
Additionally, pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of HPV vaccination, and the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, acellular pertussis; meningococcal conjugate; influenza).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- AIM 1 (PARENTS/GUARDIANS): Individuals with children between the ages of 9-17 in their care who are English speakers, live in Washington state, and have access to a telephone or computer with internet access (up to 12 parents)
- AIM 1 (PHARMACY STAFF): Employed at a Western Washington Bartell Drugs pharmacy sites and have access to a telephone or computer with internet access
- AIM 2: Pharmacy staff employed at up to four independent pharmacies in western Washington state who speak English and have access to a computer with internet access
Exclusion Criteria:
- AIM 1 (PARENTS/GUARDIANS): Those who object to having their interview audio recorded
- AIM 1 and AIM 2 (PHARMACY STAFF): Floaters/per diem. Those who object to having their interview audio recorded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aim I (interview)
Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.
|
Participate in interview
Other Names:
Undergo environmental scan
Other Names:
|
Experimental: Aim 2 (survey, training, communication intervention, and environmental scan)
Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60- minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes. Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics. |
Complete survey
Participate in interview
Other Names:
Undergo environmental scan
Other Names:
Undergo communication strategy intervention
Undergo communication training sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies
Time Frame: Up to 2 months after consent
|
Assess experiences and perceptions among parents and pharmacy staff on the challenges of obtaining/delivering HPV vaccination in pharmacies.
Assessments will be done through semi-structured interviews informed by the Theoretical Domains Framework.
Qualitative data will be analyzed using framework-guided rapid analyses
|
Up to 2 months after consent
|
Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies
Time Frame: Up to 2 months after consent
|
Assess experiences and perceptions among parents and pharmacy staff on how pharmacies support, promote, and increase access and opportunities for HPV vaccination for children.
Assessments will be done through semi-structured interviews informed by the Theoretical Domains Framework.
Qualitative data will be analyzed using framework-guided rapid analyses
|
Up to 2 months after consent
|
Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
Time Frame: Up to 6 months after baseline survey and communication training
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Obtain feedback from pharmacy staff on how the communication strategy being tested addresses barriers to obtaining/delivering HPV vaccination in pharmacies.
Assessments will be done through pre and post intervention surveys.
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Up to 6 months after baseline survey and communication training
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Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
Time Frame: Up to 6 months after baseline survey and communication training
|
Obtain feedback from pharmacy staff on how the communication strategy being tested can help improve obtaining/delivering HPV vaccination in pharmacies.
Assessments will be done through pre and post intervention surveys.
|
Up to 6 months after baseline survey and communication training
|
Acceptability of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Time Frame: Up to 6 months after baseline survey and communication training
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Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the acceptability of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.
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Up to 6 months after baseline survey and communication training
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Appropriateness of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Time Frame: Up to 6 months after baseline survey and communication training
|
Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the appropriateness of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.
|
Up to 6 months after baseline survey and communication training
|
Feasibility of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Time Frame: Up to 6 months after baseline survey and communication training
|
Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the feasibility of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.
|
Up to 6 months after baseline survey and communication training
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Self-efficacy of providing HPV vaccination
Time Frame: Up to 6 months after baseline survey and communication training
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Will use adapted, validated pre/post survey measures to assess pharmacy staff's report of the self-efficacy (i.e., confidence in their ability) to provide HPV vaccination.
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Up to 6 months after baseline survey and communication training
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Adoption of HPV vaccination
Time Frame: Up to 6 months after baseline survey and communication training
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Will conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, measured as the average HPV vaccination rate per pharmacist at each pharmacy.
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Up to 6 months after baseline survey and communication training
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Adoption of other adolescent vaccines
Time Frame: Up to 6 months after baseline survey and communication training
|
Will assess the impact of the communication strategy on adoption of other adolescent vaccines using pre-post data analysis methods like Wilcoxon signed-rank test or other nonparametric tests appropriate for small sample statistics.
|
Up to 6 months after baseline survey and communication training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Parth Shah, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1007825
- P30CA015704 (U.S. NIH Grant/Contract)
- 10600 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2020-08529 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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