Training Methods for Improving HPV Vaccination Rates

Not yet recruiting at 1 trial location

Overseen By Kate Watabayashi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Non-English speaking, Completed HPV series

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve HPV vaccination rates in pharmacies by testing different training methods for pharmacy staff. It compares regular care to specialized communication and workflow training, which focus on better recommending and facilitating the HPV vaccine. The goal is to make vaccinations more accessible and increase awareness, as low HPV vaccination rates can lead to preventable cancers later in life. Parents or guardians in the U.S. with children aged 9-17, especially if their child hasn't completed the HPV vaccine series, might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to public health by enhancing vaccination strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these training methods are safe for improving HPV vaccination rates?

Studies have shown that the HPV vaccine is safe and well-tolerated. In one survey, all participants agreed on its safety. Reports from past research show no serious side effects linked to the vaccine. Most people experience only mild side effects, such as pain at the injection site or a slight fever. Importantly, the HPV vaccine has been used for years to successfully prevent certain cancers, indicating its high safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to improve HPV vaccination rates. Unlike standard approaches that mainly focus on vaccine delivery, this trial examines how educational messages and different training strategies for pharmacy staff can influence parental decision-making and vaccination uptake. By surveying parents on various topics like vaccine safety, effectiveness, and school entry requirements, and providing specialized training for pharmacy staff, the trial aims to refine interventions that could lead to higher vaccination rates. The potential to enhance communication and workflow in pharmacies could make HPV vaccination more accessible and accepted, ultimately helping to prevent HPV-related diseases more effectively.

What evidence suggests that these training methods could improve HPV vaccination rates?

Research has shown that better communication about the HPV vaccine can lead to higher vaccination rates. In this trial, pharmacy staff will train in various communication and workflow strategies to improve these rates. Some participants will receive interpersonal communication training, while others will focus on vaccination workflow training. Another group will receive both types of training. Studies indicate that when healthcare providers communicate effectively, they can address patients' concerns and questions, reducing missed vaccination opportunities. Additionally, streamlining the vaccination process has significantly increased rates, from 12.5% to as high as 65.5% in some cases. Combining effective communication with improved processes is likely to further boost vaccination rates, as each method targets different aspects of the vaccination experience. ^{1 4 6 7 8}

Who Is on the Research Team?

Parth Shah, PharmD, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for pharmacy staff who will be trained to better communicate about and recommend HPV vaccinations. It aims to improve the vaccination process in pharmacies, making it more efficient and proactive.

Inclusion Criteria

Pharmacy staff at participating pharmacies (n ≤ 100)

I am over 18, live in the US, and have a child aged 9-17.

I am an adult with a child aged 9-17 who received an HPV vaccine at a participating pharmacy.

Exclusion Criteria

Parents whose index children have completed the HPV vaccine series

Parents whose index children have completed the HPV vaccine series

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents are randomized to receive messages on 1 of 6 topics and complete surveys. Pharmacy staff receive training and implement vaccination strategies.

12 months

Multiple visits for training and implementation

Follow-up

Participants are monitored for the effectiveness of communication strategies and vaccination delivery.

8 weeks

Surveys conducted post-vaccination

Long-term Follow-up

Assessment of reach, adoption, and implementation process over an extended period.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• HPV Vaccine

Trial Overview The study tests if training pharmacy staff in interpersonal communication or vaccination workflow, separately or together, can enhance how they talk about and suggest HPV shots compared to usual care. The goal is to boost HPV vaccine rates.

How Is the Trial Designed?

Group I: Objective 2, Group IV (strategies A and B) Experimental Treatment 4 Interventions

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 II: Objective 2, Group III (strategy B) Experimental Treatment 4 Interventions

Pharmacy staff receive the vaccination workflow training and provide vaccinations using the vaccination workflow training strategy.

Group III: Objective 2, Group II (strategy A) Experimental Treatment 4 Interventions

Pharmacy staff receive interpersonal communication training over 120 minutes and provide vaccinations using the interpersonal communication strategy.

Group IV: Objective 1, Topic VI (school entry requirements survey) Experimental Treatment 2 Interventions

Parents review 4 messages on school entry requirements and complete a survey over 15-20 minutes in support of intervention refinement on study.

Group V: Objective 1, Topic V (age to start vaccine survey) Experimental Treatment 2 Interventions

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 VI: Objective 1, Topic IV (HPV vaccine for boys survey) Experimental Treatment 2 Interventions

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 VII: Objective 1, Topic III (sexual activity survey) Experimental Treatment 2 Interventions

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

Group VIII: Objective 1, Topic II (vaccine effectiveness survey) Experimental Treatment 2 Interventions

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

Group IX: Objective 1, Topic I (safety and side effects survey) Experimental Treatment 2 Interventions

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 X: Objective 2, Group I (control) Active Control 3 Interventions

Pharmacy staff provide vaccinations per usual care.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

HPV vaccines are highly effective in preventing the transmission of HPV and related cancers, with a strong safety profile demonstrated in both prelicensure and postlicensure studies, making them recommended for everyone aged 9 to 26.

While current HPV vaccines provide limited therapeutic benefits, ongoing research into new DNA vaccines shows promise in treating existing HPV infections and precancerous lesions, highlighting the need for continued efforts to combat vaccination hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccines. Conageski, C.[2023]

The implementation of a strategic toolkit at Johns Hopkins University significantly increased HPV vaccination rates among college students from 12.2% to 20.8%, demonstrating an effective intervention in a population of 2,479 students.

The toolkit included educational presentations, visual messaging, and prompts in electronic medical records, which not only improved overall vaccination rates but also showed notable increases in vaccination rates among male students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to improve human papillomavirus (HPV) vaccination rates among college students. Kessler, R., Auwaerter, P.[2023]

This trial will evaluate two ECHO-delivered interventions aimed at increasing HPV vaccination rates among adolescents aged 11-14 in 36 primary care clinics, focusing on the effectiveness of provider training and parent recall notices.

The study aims to demonstrate that these interventions can improve HPV vaccination uptake, ultimately helping to prevent HPV-related cancers by addressing communication needs for both healthcare providers and parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Calo, WA., Shah, PD., Fogel, BN., et al.[2023]

A study involving 22,486 girls aged 11 to 17 showed that a combined intervention targeting both clinicians and families significantly increased HPV vaccination rates by 9, 8, and 13 percentage points for doses 1, 2, and 3, respectively.

The clinician-focused approach was particularly effective for starting the HPV vaccination series, while the family-focused approach helped in completing the series, highlighting the importance of a dual strategy for optimal vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. Fiks, AG., Grundmeier, RW., Mayne, S., et al.[2022]

In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.

The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

Prophylactic HPV vaccination has proven to be highly effective and well-tolerated over 20 years of clinical trials, significantly reducing the incidence of genital warts, HPV-related diseases, and precancerous lesions in various populations.

Ongoing clinical trials are exploring important questions about the vaccine's efficacy with fewer doses, its use in different age groups and health conditions, and its potential to prevent other cancers, indicating a continued commitment to optimizing HPV vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future vaccine clinical research with the licensed 2-, 4-, and 9-valent VLP HPV vaccines: What's ongoing, what's needed? Kuter, BJ., Garland, SM., Giuliano, AR., et al.[2021]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

A randomized controlled trial involving 256 young women showed that an educational video significantly increased HPV vaccine acceptability to 51.7%, compared to 33.3% for an educational handout and 28.2% for a control group (P<.01).

Both educational interventions improved HPV vaccine knowledge, with participants in the video arm scoring higher on knowledge assessments and reporting the video as more helpful in making vaccination decisions (86.2% vs 70.2%, P<.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Cory, L., Cha, B., Ellenberg, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06926062

Interpersonal Communication Training and Vaccination ... This clinical trial compares usual care to interpersonal communication training and vaccination workflow training, alone or in combination, for improving ...

2. clin.larvol.com clin.larvol.com/trial-detail/NCT06926062

Interpersonal Communication Training and Vaccination ... Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery ...

3. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2780244

Effect of Training Pediatric Clinicians in Human ... Online communication training reduced missed opportunities for HPV vaccination, particularly by improving receipt of the first HPV vaccine dose.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006565

Review Effective strategies in human papillomavirus (HPV) ... One study found whole-school engagement was 3.6 times more likely to increase HPV vaccination initiation and 3.8 times more likely to increase ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10308645/

A systematic review of interventions to promote HPV ... The purpose of the study is to systematically review the literature on interventions that promote HPV vaccination from 2015 to 2020.

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825001830

Protocol Web-Based Human Papillomavirus Education and ... This study aims to compare HPV educational and professional skills intervention effectiveness on improving provider recommendations and patient communication ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/31/NCT04660331/Prot_SAP_001.pdf

Official Title: PROMOTE Pilot Study Pharmacy multimodal ... for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination. The study will involve the enrollment of ...

8. ctv.veeva.com ctv.veeva.com/study/interpersonal-communication-training-and-vaccination-workflow-training-alone-and-in-combination-to-i

Interpersonal Communication Training and Vaccination ... This clinical trial compares usual care to interpersonal communication training and vaccination workflow training, alone or in combination, ...