Clinical trial NCT06926062: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Papillomavirus-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2025-04-13
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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

Primary outcomes:
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)
timeFrame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
measure: Perceived fit, relevance, or compatibility of human papillomavirus (HPV) vaccination or the communication strategy for a given practice site, provider, or patient (Appropriateness: Parents)
timeFrame: 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
measure: Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Pharmacy Staff)
timeFrame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
measure: Perceptions that HPV vaccinations or the communication strategy is agreeable, palatable, or satisfactory (Acceptability: Parents)
timeFrame: 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
measure: Extent to which the communication strategy was successfully implemented and used at pharmacies to support HPV vaccine delivery (Feasibility)
timeFrame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
measure: HPV vaccination delivery (Fidelity: Pharmacy Staff)
timeFrame: Up to completion of the 12 month trial period
measure: HPV vaccination delivery (Fidelity: Parents)
timeFrame: 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
measure: Self-efficacy
timeFrame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Secondary outcomes:
measure: Service penetration/effectiveness
timeFrame: Up to 12 months post intervention delivery
measure: Adoption
timeFrame: Up to 12 months post intervention delivery
measure: Reach
timeFrame: Up to 12 months post intervention delivery
measure: Outer context/setting
timeFrame: Up to 24 months
measure: Inner context/setting
timeFrame: Up to 24 months
measure: Implementation process domain
timeFrame: Up to 24 months
measure: Innovation factors/characteristics
timeFrame: Up to 24 months
measure: Individuals' domain
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Parth Shah, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: