Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial
NCT ID: NCT06926062
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1900 participants
INTERVENTIONAL
2026-03-01
2027-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Educational Intervention
Review messages on safety and side effects
Questionnaire Administration
Complete a survey
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.
Educational Intervention
Review messages on vaccine effectiveness
Questionnaire Administration
Complete a survey
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.
Educational Intervention
Review messages on sexual activity
Questionnaire Administration
Complete a survey
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.
Educational Intervention
Review messages on HPV vaccine for boys
Questionnaire Administration
Complete a survey
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.
Educational Intervention
Review message on age to start vaccine
Questionnaire Administration
Complete a survey
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.
Educational Intervention
Review messages on school entry requirements
Questionnaire Administration
Complete a survey
Objective 2, Group I (control)
Pharmacy staff provide vaccinations per usual care.
Best Practice
Provide vaccinations per usual care
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Objective 2, Group II (strategy A)
Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy.
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Training and Education
Receive interpersonal communication training
Vaccination
Provide vaccinations using the interpersonal communication strategy
Objective 2, Group III (strategy B)
Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy.
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Training and Education
Receive the vaccination workflow training
Vaccination
Provide vaccinations using the vaccination workflow training strategy
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.
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Training and Education
Receive interpersonal communication training
Training and Education
Receive the vaccination workflow training
Vaccination
Provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy
Interventions
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Best Practice
Provide vaccinations per usual care
Educational Intervention
Review messages on safety and side effects
Educational Intervention
Review messages on vaccine effectiveness
Educational Intervention
Review messages on sexual activity
Educational Intervention
Review messages on HPV vaccine for boys
Educational Intervention
Review message on age to start vaccine
Educational Intervention
Review messages on school entry requirements
Interview
Ancillary studies
Questionnaire Administration
Complete a survey
Questionnaire Administration
Ancillary studies
Training and Education
Receive interpersonal communication training
Training and Education
Receive the vaccination workflow training
Vaccination
Provide vaccinations using the interpersonal communication strategy
Vaccination
Provide vaccinations using the vaccination workflow training strategy
Vaccination
Provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Parth Shah, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Penn State University
University Park, Pennsylvania, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-01610
Identifier Type: REGISTRY
Identifier Source: secondary_id
20694
Identifier Type: OTHER
Identifier Source: secondary_id
RG1125096
Identifier Type: -
Identifier Source: org_study_id
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