Clinical trial NCT04660331: Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study
Official title: PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
timeFrame: Up to 6 months after baseline survey and communication training
measure: Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
timeFrame: Up to 6 months after baseline survey and communication training
measure: Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
timeFrame: Up to 6 months after baseline survey and communication training
measure: Self-efficacy of Providing HPV Vaccination
timeFrame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
measure: Adoption of HPV Vaccination
timeFrame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
measure: Adoption of Other Adolescent Vaccines
timeFrame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Parth Shah
role: PRINCIPAL_INVESTIGATOR
References: