Human Papillomavirus-Related CarcinomaNCT06926062
Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial
A study testing Best Practice, Educational Intervention and Interview in people with Human Papillomavirus-Related Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma
- What is being tested?
- Best Practice, Educational Intervention and Interview
- Type of treatment
- Vaccines, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jennifer Bacci, PharmD, MPH, BCACP, 206-221-3372, jbacci@uw.edu
Jennifer Bacci, PharmD, MPH, BCACP
- Not yet recruiting
Penn State University
University Park, Pennsylvania, 16802
William A. Calo, PhD, JD, MPH, 717-531-3535, wcalo@pennstatehealth.psu.edu
William A. Calo, PhD, JD, MPH
About this study
Official title: Implementing a Proactive Approach to Communicate and Teach About HPV Vaccination in Pharmacies: IMPACT HPV Study
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.
Read the 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.
- Conditions
- Human Papillomavirus-Related Carcinoma
- Being tested
- Best Practice, Educational Intervention, Interview, Questionnaire Administration, Training and Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Provide vaccinations per usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review messages on safety and side effects
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review messages on vaccine effectiveness
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review messages on sexual activity
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review messages on HPV vaccine for boys
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review message on age to start vaccine
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Review messages on school entry requirements
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Complete a survey
Questionnaire AdministrationOther
Ancillary studies
Training and EducationBehavioural
Receive interpersonal communication training
Training and EducationBehavioural
Receive the vaccination workflow training
VaccinationProcedure or surgery
Provide vaccinations using the interpersonal communication strategy
VaccinationProcedure or surgery
Provide vaccinations using the vaccination workflow training strategy
VaccinationProcedure or surgery
Provide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 1, Topic II (vaccine effectiveness survey) | Other | Parents review 4 messages on vaccine effectiveness and complete a survey over 15-20 minutes in support of intervention refinement on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 1, Topic III (sexual activity survey) | Other | Parents review 4 messages on sexual activity and complete a survey over 15-20 minutes in support of intervention refinement on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 1, Topic IV (HPV vaccine for boys survey) | Other | Parents review 4 messages on HPV vaccine for boys and complete a survey over 15-20 minutes in support of intervention refinement on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 1, Topic V (age to start vaccine survey) | Other | Parents review 4 messages on age to start vaccine and complete a survey over 15-20 minutes in support of intervention refinement on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 1, Topic VI (school entry requirements survey) | Other | Parents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Objective 2, Group I (control) | Active comparator | Pharmacy staff provide vaccinations per usual care. Receives: Other: Best Practice; Other: Interview; Other: Questionnaire Administration |
| Objective 2, Group II (strategy A) | Experimental | Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy. Receives: Other: Interview; Other: Questionnaire Administration; Behavioral: Training and Education; Procedure: Vaccination |
| Objective 2, Group III (strategy B) | Experimental | Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy. Receives: Other: Interview; Other: Questionnaire Administration; Behavioral: Training and Education; Procedure: Vaccination |
| Objective 2, Group IV (strategies A and B) | Experimental | 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. Receives: Other: Interview; Other: Questionnaire Administration; Behavioral: Training and Education; Procedure: Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 2 months post-training delivery, and 12 months post-training delivery
Secondary outcomes (8)
Service penetration/effectiveness
Will be defined by pre and post changes in overall adolescent vaccine doses delivered across trial arms. Will present unadjusted and adjusted odds ratios accounting for multiple comparisons.
Measured: Up to 12 months post intervention delivery
Adoption
Will be defined by pre and post changes in each pharmacy's HPV and other vaccination rates across trial arms.
Measured: Up to 12 months post intervention delivery
Reach
Will be defined as the total number and proportion of patients who received HPV vaccination by intervention arm, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster.
Measured: Up to 12 months post intervention delivery
Outer context/setting
Parents will be asked to identify differences between the vaccination experience at the pharmacy compared to their child's doctor's office. Example measures: "How would you rate your pharmacy's vaccination service compared to vaccination services at your child's doctor's office?"
Measured: Up to 24 months
Inner context/setting
In qualitative interviews, pharmacy staff will be asked about internal factors that impacted the delivery and uptake of the intervention, Example measure: "How would you rate the implementation process planning with the study team?" (Pharmacy staff; construct: Planning)
Measured: Up to 24 months
Implementation process domain
In a qualitative interview, pharmacy staff will be asked to rate the implementation process planning with the study team.
Measured: Up to 24 months
Innovation factors/characteristics
Pharmacy staff will be asked to compare the intervention to usual practice. Example measures: "Using the communication strategy is a better approach for delivering HPV vaccination than what I usually do."
Measured: Up to 24 months
Individuals' domain
Assessed via qualitative interviews with pharmacy staff. Example measures: "How confident are you with counseling patients on HPV vaccine?" (pharmacy staff; construct: Self-efficacy
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Parth Shah, PharmD, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926062
- Sponsor's protocol ID
- RG1125096
- Other IDs
- NCI-2025-01610, 20694
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Proactive Approach to Communicate and Teach About HPV Vaccination in Pharmacies: IMPACT HPV Study
- ClinicalTrials.gov ID
- NCT06926062
- Acronym / sponsor ID
- RG1125096
- Conditions
- Human Papillomavirus-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Objective 1, Topic I (safety and side effects survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on safety and side effects and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 1, Topic II (vaccine effectiveness survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on vaccine effectiveness and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 1, Topic III (sexual activity survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on sexual activity and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 1, Topic IV (HPV vaccine for boys survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on HPV vaccine for boys and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 1, Topic V (age to start vaccine survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on age to start vaccine and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 1, Topic VI (school entry requirements survey) | Other | Other: Educational Intervention, Other: Questionnaire AdministrationParents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study. |
| Objective 2, Group I (control) | Active comparator | Other: Best Practice, Other: Interview, Other: Questionnaire AdministrationPharmacy staff provide vaccinations per usual care. |
| Objective 2, Group II (strategy A) | Experimental | Other: Interview, Other: Questionnaire Administration, Behavioral: Training and Education, Procedure: VaccinationPharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy. |
| Objective 2, Group III (strategy B) | Experimental | Other: Interview, Other: Questionnaire Administration, Behavioral: Training and Education, Procedure: VaccinationPharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy. |
| Objective 2, Group IV (strategies A and B) | Experimental | Other: Interview, Other: Questionnaire Administration, Behavioral: Training and Education, Procedure: VaccinationPharmacy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyProvide vaccinations per usual care | Other | Objective 2, Group I (control) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview messages on safety and side effects | Other | Objective 1, Topic I (safety and side effects survey) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview messages on vaccine effectiveness | Other | Objective 1, Topic II (vaccine effectiveness survey) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview messages on sexual activity | Other | Objective 1, Topic III (sexual activity survey) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview messages on HPV vaccine for boys | Other | Objective 1, Topic IV (HPV vaccine for boys survey) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview message on age to start vaccine | Other | Objective 1, Topic V (age to start vaccine survey) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReview messages on school entry requirements | Other | Objective 1, Topic VI (school entry requirements survey) |
| InterviewAncillary studies | Other | Objective 2, Group I (control), Objective 2, Group II (strategy A), Objective 2, Group III (strategy B), Objective 2, Group IV (strategies A and B) |
| Questionnaire AdministrationComplete a survey | Other | Objective 1, Topic I (safety and side effects survey), Objective 1, Topic II (vaccine effectiveness survey), Objective 1, Topic III (sexual activity survey), Objective 1, Topic IV (HPV vaccine for boys survey), Objective 1, Topic V (age to start vaccine survey), Objective 1, Topic VI (school entry requirements survey) |
| Questionnaire AdministrationAncillary studies | Other | Objective 2, Group I (control), Objective 2, Group II (strategy A), Objective 2, Group III (strategy B), Objective 2, Group IV (strategies A and B) |
| Training and EducationReceive interpersonal communication training | Behavioural | Objective 2, Group II (strategy A), Objective 2, Group IV (strategies A and B) |
| Training and EducationReceive the vaccination workflow training | Behavioural | Objective 2, Group III (strategy B), Objective 2, Group IV (strategies A and B) |
| VaccinationProvide vaccinations using the interpersonal communication strategy | Procedure or surgery | Objective 2, Group II (strategy A) |
| VaccinationProvide vaccinations using the vaccination workflow training strategy | Procedure or surgery | Objective 2, Group III (strategy B) |
| VaccinationProvide vaccinations using both the interpersonal communication strategy and the vaccination workflow training strategy | Procedure or surgery | Objective 2, Group IV (strategies A and B) |
Primary outcome
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
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.
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
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.
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
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.
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
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.
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
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.
HPV vaccination delivery (Fidelity: Pharmacy Staff)
Time frame: Up to completion of the 12 month trial period
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.
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
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.
Self-efficacy
Time frame: At baseline, 2 months post-training delivery, and 12 months post-training delivery
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.
8 secondary outcomes
Service penetration/effectiveness
Time frame: Up to 12 months post intervention delivery
Adoption
Time frame: Up to 12 months post intervention delivery
Reach
Time frame: Up to 12 months post intervention delivery
Outer context/setting
Time frame: Up to 24 months
Inner context/setting
Time frame: Up to 24 months
Implementation process domain
Time frame: Up to 24 months
Innovation factors/characteristics
Time frame: Up to 24 months
Individuals' domain
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Human Papillomavirus-Related Carcinoma
Active, not recruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
RecruitingPhase 2
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingObservational study
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Oropharyngeal Cancer, HPV-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parth Shah, PharmD, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Interview in people with Human Papillomavirus-Related Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan Glascock (206-667-7438, mglascoc@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.