Recruiting

Interpersonal Training & Workflow

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT06926062

Conditions

Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Educational Intervention

Educational Intervention

Educational Intervention

Educational Intervention

Study Details

Brief summary:

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.

Conditions

Human Papillomavirus-Related Carcinoma

Study ID

NCT06926062

Start date

Sep 1, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1900 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Morgan Glascock

206-667-7438mglascoc@fredhutch.org

Kate Watabayashi

206-667-5624kwatabay@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Jennifer Bacci, PharmD, MPH, BCACP

206-221-3372jbacci@uw.edu

Principal Investigator:

Jennifer Bacci, PharmD, MPH, BCACP

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-07-30.