Training Methods for Improving HPV Vaccination Rates

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

1900 Participants Needed

Trial Summary

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 data supports the effectiveness of the HPV vaccine treatment?

Research shows that using strategies like provider communication, prompts, and feedback can improve HPV vaccination rates. Additionally, population health strategies such as reminder systems and school-based programs have been effective in increasing vaccine uptake. ^{1 2 3 4 5}

Is the HPV vaccine safe for humans?

The HPV vaccines, including Gardasil and Cervarix, have been shown to be safe in numerous studies conducted over more than 20 years. They are well tolerated and have an excellent safety profile, with ongoing research continuing to support their safety in various populations. ^{4 6 7 8 9}

How does the HPV vaccine treatment differ from other treatments for HPV-related conditions?

The HPV vaccine is unique because it is a preventive measure, not a treatment for existing HPV infections or related conditions. It works by preventing the transmission of the virus, which can lead to cancers, rather than treating the virus or its effects after infection. Unlike other treatments that might address symptoms or complications, the vaccine aims to stop the virus from causing harm in the first place. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Parth Shah, PharmD, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Learning Collaborative Model to Improve Human Papillomavirus Vaccination Rates in Primary Care. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies to improve human papillomavirus (HPV) vaccination rates among college students. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Provider Communication, Prompts, and Feedback to Improve HPV Vaccination Rates in Resident Clinics. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The most effective and promising population health strategies to advance human papillomavirus vaccination. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

7. United States 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? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

HPV vaccine acceptance, utilization and expected impacts in the U.S.: Where are we now? [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

HPV and HPV vaccine education intervention: effects on parents, healthcare staff, and school staff. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial. [2019]

12. United States 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccines. [2023]