Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

Human Papillomavirus Infection Clinical Trial

— PROMOTE  

Official title:

PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660331
• Other study ID #: RG1007825
• Secondary ID: NCI-2020-0852910
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Communication Intervention
Undergo communication strategy intervention
• Communication Skills Training
Undergo communication training sessions

Behavioral:
• Healthcare Activity
Participate in interview
• Healthcare Activity
Undergo environmental scan

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 2 months after consent
Primary	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	Up to 2 months after consent
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training
Primary	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.	Up to 6 months after baseline survey and communication training