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

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06926062
Status
Not Yet Recruiting

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Conditions

  • Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Best Practice — OTHER
    Provide vaccinations per usual care
  • Educational Intervention — OTHER
    Review messages on safety and side effects
  • Educational Intervention — OTHER
    Review messages on vaccine effectiveness
  • Educational Intervention — OTHER
    Review messages on sexual activity
  • Educational Intervention — OTHER
    Review messages on HPV vaccine for boys
  • Educational Intervention — OTHER
    Review message on age to start vaccine
  • Educational Intervention — OTHER
    Review messages on school entry requirements
  • Interview — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Complete a survey
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Training and Education — BEHAVIORAL
    Receive interpersonal communication training
  • Training and Education — BEHAVIORAL
    Receive the vaccination workflow training
  • Vaccination — PROCEDURE
    Provide vaccinations using the interpersonal communication strategy
  • Vaccination — PROCEDURE
    Provide vaccinations using the vaccination workflow training strategy
  • Vaccination — PROCEDURE
    Provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jul 2025
Primary completion
Sep 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
1,900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Objective 1, Topic I (safety and side effects survey)
    Parents review 4 messages on safety and side effects and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Other: Objective 1, Topic II (vaccine effectiveness survey)
    Parents review 4 messages on vaccine effectiveness and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Other: Objective 1, Topic III (sexual activity survey)
    Parents review 4 messages on sexual activity and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Other: Objective 1, Topic IV (HPV vaccine for boys survey)
    Parents review 4 messages on HPV vaccine for boys and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Other: Objective 1, Topic V (age to start vaccine survey)
    Parents review 4 messages on age to start vaccine and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Other: Objective 1, Topic VI (school entry requirements survey)
    Parents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study.
  • Active Comparator: Objective 2, Group I (control)
    Pharmacy staff provide vaccinations per usual care.
  • Experimental: Objective 2, Group II (strategy A)
    Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy.
  • Experimental: Objective 2, Group III (strategy B)
    Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy.
  • Experimental: Objective 2, 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Penn State UniversityUniversity ParkPennsylvania16802
William A. Calo, PhD, JD, MPH
717-531-3535
William A. Calo, PhD, JD, MPH (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Jennifer Bacci, PharmD, MPH, BCACP
206-221-3372
Jennifer Bacci, PharmD, MPH, BCACP (PRINCIPAL_INVESTIGATOR)

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