This clinical trial compares usual care to interpersonal communication training and vaccination workflow training, alone or in combination, for improving communication about and recommendations for human papillomavirus (HPV) and other vaccinations in pharmacies. Low HPV vaccination in the United States has placed unvaccinated children at risk of developing cancers as adults that could have been prevented. Pharmacies can be convenient for vaccination because they are open longer hours, have shorter wait times, can see patients without appointments and may cost less. However, many people are not aware that vaccination is available in pharmacies and some pharmacies lack the commitment from staff to vaccinate or may not have protocols in place for vaccination. Proactive communication approaches to recommending HPV vaccination have been shown to be effective in medical offices but have not been tested in the pharmacy setting. Interpersonal communication training incorporates the 5 A's (assess, advice, agree, assist and arrange) behavioral counseling framework to strongly recommend HPV and other vaccines and effectively answer any questions or concerns about vaccination. Vaccination workflow training establishes vaccination decision support strategies that pharmacies use to improve vaccination workflows. Interpersonal communication training and vaccination workflow training alone or in combination may improve communication and recommendations for HPV vaccination and increase HPV vaccination in pharmacies.
OBJECTIVE 1: Adults aged 18 years or older who live in the 50 United States (U.S.) states and Washington District of Columbia (D.C.) and are parents or guardians of children ages 9-17 are eligible to take the national survey (n ≤ 1,600, with anticipated enrollment of n = ~1,500)
OBJECTIVE 2: Pharmacy staff at participating pharmacies (n ≤ 100)
OBJECTIVE 2: Adults aged 18 years or older whose children ages 9-17 received an HPV vaccine at one of the participating pharmacies in study year 2 (n ≤ 200)
OBJECTIVE 1: Non-English speaking as the survey is only available for this project in English
OBJECTIVE 1: Parents whose index children have completed the HPV vaccine series
OBJECTIVE 2: Non-English speaking as the study funding only provided resources for surveys and interview materials to be available in English
OBJECTIVE 2: Parents whose index children have completed the HPV vaccine series
Factorial
Best Practice
Other interventionProvide vaccinations per usual care
Educational Intervention
Other interventionReview messages on safety and side effects
Educational Intervention
Other interventionReview messages on vaccine effectiveness
Educational Intervention
Other interventionReview messages on sexual activity
Educational Intervention
Other interventionReview messages on HPV vaccine for boys
Educational Intervention
Other interventionReview message on age to start vaccine
Educational Intervention
Other interventionReview messages on school entry requirements
Interview
Other interventionAncillary studies
Questionnaire Administration
Other interventionComplete a survey
Questionnaire Administration
Other interventionAncillary studies
Training and Education
BehavioralReceive interpersonal communication training
Training and Education
BehavioralReceive the vaccination workflow training
Vaccination
Procedure/SurgeryProvide vaccinations using the interpersonal communication strategy
Vaccination
Procedure/SurgeryProvide vaccinations using the vaccination workflow training strategy
Vaccination
Procedure/SurgeryProvide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy
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Treatment groupsSee each treatment group below.
Perceived fit, relevance, or compatibility of human papillomavirus (HPV) vaccination or the communication strategy for a given practice site, provider, or patient (Appropriateness: Pharmacy Staff)
Assessed via survey. 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. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
Perceived fit, relevance, or compatibility of human papillomavirus (HPV) vaccination or the communication strategy for a given practice site, provider, or patient (Appropriateness: Parents)
Appropriateness outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate appropriateness are sourced from evidence-based assessments of Intervention Appropriateness Measure (IAM) from Weiner et al. (2017). 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 appropriate in supporting HPV vaccination delivery to children ages 9-17.
Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Pharmacy Staff)
Assessed via survey. 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. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Parents)
Acceptability outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate acceptability are sourced from evidence-based assessments of Acceptability of Intervention Measure (AIM) from Weiner et al. (2017). 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.
Service penetration/effectiveness
Will be defined by pre and post changes in overall adolescent vaccine doses delivered across trial arms. Will present unadjusted and adjusted odds ratios accounting for multiple comparisons.
Adoption
Will be defined by pre and post changes in each pharmacy's HPV and other vaccination rates across trial arms.
Reach
Will be defined as the total number and proportion of patients who received HPV vaccination by intervention arm, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster.
Outer context/setting
Parents will be asked to identify differences between the vaccination experience at the pharmacy compared to their child's doctor's office. Example measures: "How would you rate your pharmacy's vaccination service compared to vaccination services at your child's doctor's office?"
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Fred Hutchinson Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
