NCT06926062|Not Yet Recruiting

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

Implementing a Proactive Approach to Communicate and Teach About HPV Vaccination in Pharmacies: IMPACT HPV Study

Fred Hutchinson Cancer Center ClinicalTrials.gov

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3 other identifiers

RG1125096NCI-2025-0161020694

Study Type

interventional

Target

1,900

Locations

1 country

Sites

Timeline

RegisteredApr 2025

StartedJun 2026

CompletionOct 2027

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,900

participants targeted

Target at P75+ for not_applicable

Timeline

16mo left

Started Jun 2026

Geographic Reach

1 country

2 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

March 19, 2025

Completed

25 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed

1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 13, 2026

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

March 19, 2025

Last Update Submit

March 11, 2026

Conditions

Human Papillomavirus-Related Carcinoma

Outcome Measures

Primary Outcomes (8)

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)
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was appropriate to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
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)
Appropriateness outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate appropriateness are sourced from evidence-based assessments of Intervention Appropriateness Measure (IAM) from Weiner et al. (2017). There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was appropriate in supporting HPV vaccination delivery to children ages 9-17.
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)
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
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)
Acceptability outcomes will be assessed via survey to parents following their child's HPV vaccination. The four questions to evaluate acceptability are sourced from evidence-based assessments of Acceptability of Intervention Measure (AIM) from Weiner et al. (2017). There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17.
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)
Assessed via survey. The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was feasible to support HPV vaccination delivery to children ages 9-17. Study researchers will calculate the average scale based on numeric scores. For questions that are asked in a reverse fashion, study researchers will reverse the score accordingly.
At baseline, 2 months post-training delivery, and 12 months post-training delivery
HPV vaccination delivery (Fidelity: Pharmacy Staff)
Will conduct audits of the pharmacy electronic records to assess adherence to HPV vaccination protocols, by comparing the proportion of HPV vaccines given "on time" to children aged 9-10 and 11-12 versus "late" to children aged 13-17.
Up to completion of the 12 month trial period
HPV vaccination delivery (Fidelity: Parents)
HPV vaccine delivery fidelity will be assessed via survey to parents following their child's HPV vaccination. Parents will be asked to indicate which of seven, if any, supportive vaccination behaviors occurred during their visit in a "select all that apply" format. The seven experiences correspond to vaccination behaviors that have been shown in formative research to support HPV vaccine delivery and parents' perceptions of acceptability and appropriateness of HPV vaccination workflows using the 5As Behavioral Counseling Model (Sturgiss et al. 2017). The supportive behaviors include eligibility screening, recommendation, counseling, documentation and record retrieval support, PCP reporting, and scheduling for follow up. To summarize the overall fidelity to the workflow per respondent, study researchers will create a composite "fidelity score" by summing the number of behaviors each parent endorsed (range: 0-7). Higher scores will indicate greater adherence to the recommended workflow.
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
Assessed via survey. The survey was developed by study researchers and includes validated measures from a 31-item medication therapy management (MTM) efficacy scale (Martin B, et al. 2010) and a statewide survey of healthcare providers (McRee AL, et.al. 2014). It will be used to capture change of participants' perceptions pre/post training. For this outcome there are five answers to each survey question reflecting how confident the respondent is in performing tasks related to providing HPV vaccinations to children, and each answer is given a score from 1 to 5, with 1 being not at all confident/strongly disagree and 5 being completely confident/strongly agree. Higher numerical scores on the 5-point scale reflect higher levels of self-efficacy or confidence in personal ability to complete vaccination process actions. Study researchers will calculate the average scale based on numeric scores.
At baseline, 2 months post-training delivery, and 12 months post-training delivery

Secondary Outcomes (8)

Service penetration/effectiveness
Up to 12 months post intervention delivery
Adoption
Up to 12 months post intervention delivery
Reach
Up to 12 months post intervention delivery
Outer context/setting
Up to 24 months
Inner context/setting
Up to 24 months
+3 more secondary outcomes

Study Arms (10)

Objective 1, Topic I (safety and side effects survey)

OTHER

Parents review 4 messages on safety and side effects and complete a survey over 15-20 minutes in support of intervention refinement on study.