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Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study (PROMOTE)

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication Intervention
Communication Skills Training
Healthcare Activity
Healthcare Activity
Survey Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Papillomavirus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 one or two 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 (PHARMACY STAFF): Floaters/per diem. Those who object to having their interview audio recorded

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aim I (interview)

Aim 2 (survey, training, communication intervention, and environmental scan)

Arm Description

Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.

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.

Outcomes

Primary Outcome Measures

Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies
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
Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies
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
Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
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.
Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
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.
Acceptability of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
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.
Appropriateness of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
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.
Feasibility of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
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.
Self-efficacy of providing HPV vaccination
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.
Adoption of HPV vaccination
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.
Adoption of other adolescent vaccines
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
August 28, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04660331
Brief Title
Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study
Acronym
PROMOTE
Official Title
PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial investigates how a communication strategy works in increasing human papillomavirus (HPV) vaccines in community pharmacies among adolescents. Although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. The purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about HPV vaccination in order to increase HPV vaccination rates.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aim I (interview)
Arm Type
Experimental
Arm Description
Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.
Arm Title
Aim 2 (survey, training, communication intervention, and environmental scan)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Communication Intervention
Intervention Description
Undergo communication strategy intervention
Intervention Type
Other
Intervention Name(s)
Communication Skills Training
Intervention Description
Undergo communication training sessions
Intervention Type
Behavioral
Intervention Name(s)
Healthcare Activity
Other Intervention Name(s)
Health Care Activity, Healthcare
Intervention Description
Participate in interview
Intervention Type
Behavioral
Intervention Name(s)
Healthcare Activity
Other Intervention Name(s)
Health Care Activity, Healthcare
Intervention Description
Undergo environmental scan
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Primary Outcome Measure Information:
Title
Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies
Description
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
Time Frame
Up to 2 months after consent
Title
Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies
Description
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
Time Frame
Up to 2 months after consent
Title
Behavioral barriers to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Behavioral facilitators to human papillomavirus (HPV) vaccination in pharmacies: Pharmacy staff
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Acceptability of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Appropriateness of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Feasibility of providing HPV vaccination to children and of the proposed communication strategy to support HPV vaccination
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Self-efficacy of providing HPV vaccination
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Adoption of HPV vaccination
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training
Title
Adoption of other adolescent vaccines
Description
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.
Time Frame
Up to 6 months after baseline survey and communication training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parth Shah
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

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