Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial

Official title

Implementing a Proactive Approach to Communicate and Teach About HPV Vaccination in Pharmacies: IMPACT HPV Study

Overview

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.

Detailed description

OUTLINE:

OBJECTIVE 1: Parents are randomized to receive messages on 1 of 6 topics.

TOPIC I (SAFETY AND SIDE EFFECTS): Parents review 4 messages on safety and side effects and complete a survey over 15-20 minutes in support of intervention refinement on study.

TOPIC II (VACCINE EFFECTIVENESS): Parents review 4 messages on vaccine effectiveness and complete a survey over 15-20 minutes in support of intervention refinement on study.

TOPIC III (SEXUAL ACTIVITY): Parents review 4 messages on sexual activity and complete a survey over 15-20 minutes in support of intervention refinement on study.

TOPIC IV (HPV VACCINE FOR BOYS): Parents review 4 messages on HPV vaccine for boys and complete a survey over 15-20 minutes in support of intervention refinement on study.

TOPIC V (AGE TO START VACCINE): Parents review 4 messages on age to start vaccine and complete a survey over 15-20 minutes in support of intervention refinement on study.

TOPIC VI (SCHOOL ENTRY REQUIREMENTS): Parents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study.

OBJECTIVE 2: Pharmacies are assigned to a strata of 4 pharmacies with similar characteristics and pharmacies within each strata are randomized to 1 of 4 groups.

GROUP I (CONTROL): Pharmacy staff provide vaccinations per usual care.

GROUP II (STRATEGY A): Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy.

GROUP III (STRATEGY B): Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy.

GROUP IV (STRATEGIES A AND B): Pharmacy staff receive interpersonal communication training as well as vaccination workflow training and provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy.

Interventions

• Other Best Practice
  Provide vaccinations per usual care
• Other Educational Intervention
  Review messages on safety and side effects
• Other Educational Intervention
  Review messages on vaccine effectiveness
• Other Educational Intervention
  Review messages on sexual activity
• Other Educational Intervention
  Review messages on HPV vaccine for boys
• Other Educational Intervention
  Review message on age to start vaccine
• Other Educational Intervention
  Review messages on school entry requirements
• Other Interview
  Ancillary studies
• Other Questionnaire Administration
  Complete a survey
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• 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) [Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery]
• Perceived fit, relevance, or compatibility of human papillomavirus (HPV) vaccination or the communication strategy for a given practice site, provider, or patient (Appropriateness: Parents) [Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date]
• Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Pharmacy Staff) [Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery]
• Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Parents) [Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date]
• Extent to which the communication strategy was successfully implemented and used at pharmacies to support HPV vaccine delivery (Feasibility) [Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery]
• HPV vaccination delivery (Fidelity: Pharmacy Staff) [Time frame: Up to completion of the 12 month trial period]
• HPV vaccination delivery (Fidelity: Parents) [Time frame: The outcome will be measured at one time point, at a time frame from the date of vaccine administration to up to 8 weeks after that vaccine administration date]
• Self-efficacy [Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery]

Secondary outcome measures (8)

• Service penetration/effectiveness [Time frame: Up to 12 months post intervention delivery]
• Adoption [Time frame: Up to 12 months post intervention delivery]
• Reach [Time frame: Up to 12 months post intervention delivery]
• Outer context/setting [Time frame: Up to 24 months]
• Inner context/setting [Time frame: Up to 24 months]
• Implementation process domain [Time frame: Up to 24 months]
• Innovation factors/characteristics [Time frame: Up to 24 months]
• Individuals' domain [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• Penn State University — University Park
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT06926062 · RG1125096 · NCI-2025-01610 · 20694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗