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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-10-01

Brief Summary

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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

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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.

Conditions

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Human Papillomavirus-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review messages on safety and side effects

Questionnaire Administration

Intervention Type OTHER

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review messages on vaccine effectiveness

Questionnaire Administration

Intervention Type OTHER

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review messages on sexual activity

Questionnaire Administration

Intervention Type OTHER

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review messages on HPV vaccine for boys

Questionnaire Administration

Intervention Type OTHER

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review message on age to start vaccine

Questionnaire Administration

Intervention Type OTHER

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.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Review messages on school entry requirements

Questionnaire Administration

Intervention Type OTHER

Complete a survey

Objective 2, Group I (control)

Pharmacy staff provide vaccinations per usual care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Provide vaccinations per usual care

Interview

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Training and Education

Intervention Type BEHAVIORAL

Receive interpersonal communication training

Vaccination

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Training and Education

Intervention Type BEHAVIORAL

Receive the vaccination workflow training

Vaccination

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Training and Education

Intervention Type BEHAVIORAL

Receive interpersonal communication training

Training and Education

Intervention Type BEHAVIORAL

Receive the vaccination workflow training

Vaccination

Intervention Type PROCEDURE

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

Intervention Type OTHER

Educational Intervention

Review messages on safety and side effects

Intervention Type OTHER

Educational Intervention

Review messages on vaccine effectiveness

Intervention Type OTHER

Educational Intervention

Review messages on sexual activity

Intervention Type OTHER

Educational Intervention

Review messages on HPV vaccine for boys

Intervention Type OTHER

Educational Intervention

Review message on age to start vaccine

Intervention Type OTHER

Educational Intervention

Review messages on school entry requirements

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Complete a survey

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Training and Education

Receive interpersonal communication training

Intervention Type BEHAVIORAL

Training and Education

Receive the vaccination workflow training

Intervention Type BEHAVIORAL

Vaccination

Provide vaccinations using the interpersonal communication strategy

Intervention Type PROCEDURE

Vaccination

Provide vaccinations using the vaccination workflow training strategy

Intervention Type PROCEDURE

Vaccination

Provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy

Intervention Type PROCEDURE

Other Intervention Names

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standard of care standard therapy Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Morgan Glascock

Role: CONTACT

206-667-7438

Kate Watabayashi

Role: CONTACT

206-667-5624

Facility Contacts

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William A. Calo, PhD, JD, MPH

Role: primary

717-531-3535

Jennifer Bacci, PharmD, MPH, BCACP

Role: primary

206-221-3372

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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