Skip to main content
OpenTrials
Completed

NCT Number: NCT04660331

Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention

Other

Undergo communication strategy intervention

communication skills training

Other

Undergo communication training sessions

Healthcare Activity

Behavioral

Participate in interview

Other names: Health Care Activity, Healthcare

Survey Administration

Other

Complete survey

Primary outcomes

  1. 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

    The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.

  2. 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

    The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was appropriate to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.

  3. 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

    The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was feasible to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.

  4. Self-efficacy of Providing HPV Vaccination

    Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)

    The survey was developed by study researchers and included validated measures from a 31-item medication therapy management (MTM) efficacy scale (Martin B, et al. 2010) and a statewide survey of healthcare providers (McRee AL, et.al. 2014). It was used to capture change of participants' perceptions pre/post training. For this outcome there were five answers to each survey question reflecting how confident the respondent is in performing tasks related to providing HPV vaccinations to children, and each answer is given a score from 1 to 5, with 1 being not at all confident/strongly disagree and 5 being completely confident/strongly agree. Higher numerical scores on the 5-point scale reflect higher levels of self-efficacy or confidence in personal ability to complete vaccination process actions. We calculated the average scale based on numeric scores.

  5. Adoption of HPV Vaccination

    Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)

    Will conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, measured as the total sum (count) of HPV vaccinations administered by all eligible Aim 2 pharmacists.

  6. Adoption of Other Adolescent Vaccines

    Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)

    Will conduct audits of the pharmacy electronic records to assess adoption of other adolescent vaccination, measured as the total sum (count) of adolescent vaccinations administered by all eligible Aim 2 pharmacists.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: PROMOTE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2020
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.