Intervention Strategies for Increasing HPV Vaccination Rates

(HPV MISTICS Trial)

Overseen By Lindsay Fuzzell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: None

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

Compensation: Varies

Number of Visits: Unknown

564 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost HPV vaccination rates in children aged 11-17 at community health centers in Florida. It examines various strategies involving parents, healthcare providers, and the health centers to determine the most effective approach. Parents with children who have not started or completed the HPV vaccine series and have recently received care at one of these centers may be eligible to participate. As an unphased trial, this study provides a unique opportunity to contribute to public health by identifying effective methods to increase vaccination rates.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these intervention strategies are safe for increasing HPV vaccination rates?

Research has shown that the HPV vaccine, Gardasil 9, has undergone thorough safety studies. In large studies with over 15,000 participants, the vaccine proved safe and effective. Since 2014, the FDA has approved Gardasil 9 to prevent various cancers caused by the human papillomavirus (HPV), such as cervical and throat cancers.

Over more than 15 years of safety monitoring, the vaccine has remained well-tolerated. Serious side effects are rare, and most people experience only mild reactions like soreness at the injection site. These findings suggest that the HPV vaccine is safe for its intended age groups.

This evidence reassures the vaccine's safety and supports its use in public health efforts to increase vaccination rates among younger people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HPV MISTICS intervention because it takes a comprehensive approach to boost HPV vaccination rates, targeting not just patients but also parents and healthcare providers. Unlike standard methods that might focus solely on patient awareness, this strategy involves three levels: empowering vaccine champions, educating parents, and training providers. This multi-faceted approach could lead to a more significant increase in vaccination rates by addressing barriers at multiple points in the healthcare process. By engaging community health centers in waves, the trial aims to assess the effectiveness of this holistic intervention across different settings, potentially offering a scalable model for improving vaccination uptake nationwide.

What evidence suggests that this trial's interventions could be effective in increasing HPV vaccination rates?

Research shows that HPV vaccines effectively prevent cancers caused by the human papillomavirus. Over 98% of individuals who complete the vaccine series develop a strong immune response, protecting against the HPV types responsible for most cervical cancers. Studies have found that the 9-valent HPV vaccine, such as Gardasil 9, protects against HPV-related cancers with over 90% effectiveness. Long-term research confirms the vaccine's safety and lasting protection. This trial tests intervention strategies to increase vaccination rates by involving parents, healthcare providers, and health centers. Participants will join either the initial group of community health centers or the second group, each receiving the intervention at different times. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan T Vadaparampil, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Shannon Christy, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking parents of 11-17 year olds, healthcare providers, and staff at certain health centers in Florida. It's focused on those who have not started or completed the HPV vaccine series. Participants must be over 18 and interact with parents of adolescents who are eligible for the HPV vaccine.

Inclusion Criteria

I am over 18, work in a qualified health center, and can read, write, and speak English.

I am over 18, work in a qualified health center, interact with parents of teens, and can use English.

I am a parent of a child aged 11-17 who hasn't started or completed the HPV vaccine and we've visited a qualified health center recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of parent-, provider-, and health center-level strategies to promote HPV vaccination

5 years

Follow-up

Participants are monitored for HPV vaccine initiation and completion rates, and implementation outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• HPV MISTICS- HPV Vaccine Champion Level
• HPV MISTICS - Parent Level
• HPV MISTICS -Provider Level

Trial Overview The 'HPV MISTICS' study tests strategies to increase HPV vaccination rates among teens at community health centers. It involves different approaches targeting healthcare champions, parents, and providers to see which methods work best in promoting vaccinations.

How Is the Trial Designed?

Group I: Wave 2: Second Community Health Centers Experimental Treatment 3 Interventions

Second group of community health centers to receive intervention

Group II: Wave 1: Initial Community Health Centers Experimental Treatment 3 Interventions

Initial group of community health centers to receive intervention

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Health Choice Network

Collaborator

Trials

6

Recruited

5,820,000+

Published Research Related to This Trial

Physicians identified key strategies to improve HPV vaccination rates, including reminders, education, and scheduling future appointments at the time of the first dose, which can be easily implemented with minimal resources.

Coupling the HPV vaccine with other adolescent vaccines and emphasizing its role in preventing cancer and genital warts were also effective methods used by providers with above-average vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Louisiana Physicians Are Increasing HPV Vaccination Rates. Williams, DL., Wheeler, CS., Lawrence, M., et al.[2018]

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]

Over ten years since its introduction, various strategies have been implemented to improve and sustain HPV vaccination rates, involving public health policies, education programs, and clinical practices.

Future efforts to promote HPV vaccination should adopt a multi-level and integrated approach to effectively combat misinformation and enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective and prospective look at strategies to increase adolescent HPV vaccine uptake in the United States. Head, KJ., Biederman, E., Sturm, LA., et al.[2023]

The 'HPV Vax at 9' intervention significantly increased HPV vaccination rates among 9- and 10-year-olds, with initiation rates rising by over 30% at participating clinics during the first year.

By integrating HPV vaccination with routine well child visits and providing additional support tools, the completion rates for the vaccine series improved by up to 40%, demonstrating a sustainable approach to enhance vaccination efforts even during challenges like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-level quality improvement strategies to optimize HPV vaccination starting at the 9-year well child visit: Success stories from two private pediatric clinics. Zorn, S., Darville-Sanders, G., Vu, T., et al.[2023]

In a study of 58,881 healthy women across 11 trials, the nine-valent HPV vaccine (9vHPV) was found to be the most effective against persistent infection with HPV 16, achieving a 97% efficacy rate.

The bivalent HPV vaccine (2vHPV) showed the highest efficacy against HPV 18 at 98%, while the quadrivalent HPV vaccine (4vHPV) was most effective for preventing cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV 16 and 18, with efficacy rates of 99% and 97%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of human papillomavirus vaccines: systematic review and network meta-analysis. Lin, R., Jin, H., Fu, X.[2023]

There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.

This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

The 9-valent HPV vaccine (9vHPV) is highly immunogenic in females aged 12-26 who previously received the quadrivalent HPV vaccine (qHPV), with over 98% showing seropositivity for additional HPV types 31/33/45/52/58 after the third dose.

While injection-site adverse events were more common in the 9vHPV group (91.1%) compared to placebo (43.9%), systemic adverse events were similar between both groups, indicating that the 9vHPV vaccine is generally well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Garland, SM., Cheung, TH., McNeill, S., et al.[2016]

The nonavalent HPV vaccine (9vHPV) has shown over 90% efficacy in preventing cervical, vulvar, and vaginal precancers caused by HPV types 16, 18, and five additional cancer-causing types (31, 33, 45, 52, 58) in Phase III clinical studies.

9vHPV has the potential to prevent up to 93% of cervical cancer cases and has demonstrated lasting antibody responses for at least five years, indicating its long-term effectiveness in reducing the burden of HPV-related cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus. Toh, ZQ., Kosasih, J., Russell, FM., et al.[2020]

The 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

A study involving 221 parents of adolescents showed that reducing parents' uncertainties about the HPV vaccine significantly increased the likelihood of their children receiving the next vaccine dose, with a 1-point reduction in uncertainty correlating to 4.9 times higher odds of vaccination.

Concerns about the vaccine's safety were linked to lower completion rates of the HPV vaccine series, highlighting the need for educational efforts to address these safety concerns among parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between parent attitudes and receipt of human papillomavirus vaccine in adolescents. VanWormer, JJ., Bendixsen, CG., Vickers, ER., et al.[2021]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

A multifaceted intervention in a regional health care system significantly increased HPV vaccine coverage among 11- to 12-year-olds from 41% to 59%, outperforming control departments where coverage only rose from 32% to 45%.

The most notable increase in vaccination rates occurred after provider education and the implementation of patient reminder postcards, highlighting the effectiveness of targeted communication strategies in improving vaccine uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Human Papillomavirus Vaccine Use in an Integrated Health System: Impact of a Provider and Staff Intervention. McLean, HQ., VanWormer, JJ., Chow, BDW., et al.[2022]

The new nonavalent HPV vaccine (9vHPV) shows a very strong immune response with nearly 100% seroconversion rates and has a safety profile similar to the quadrivalent vaccine (qHPV), although it may cause more local reactions like swelling, especially when given with other vaccines.

The 9vHPV vaccine offers additional protection against HPV-related cancers, potentially preventing 8% to 18% more cases compared to previous vaccines, but its overall impact will depend on various factors such as duration of protection and population-specific HPV type distribution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on the 9-valent HPV vaccine. Lopalco, PL.[2018]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11180554/

HPV Multilevel Intervention Strategies Targeting Immunization ... This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9858349/

An Update on Human Papillomavirus Vaccination in the ... This article highlights the evidence that the human papillomavirus vaccine is a safe and a highly effective way to prevent cervical cancer.

3. withpower.com withpower.com/trial/phase-papilloma-11-2022-c9363

Intervention Strategies for Increasing HPV Vaccination Rates The 9-valent HPV vaccine (9vHPV), known as Gardasil 9, has shown high effectiveness in preventing cervical, vulvar, and vaginal precancers caused by HPV types, ...

4. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.

5. progressreport.cancer.gov progressreport.cancer.gov/prevention/hpv_immunization

HPV Vaccination - Cancer Trends Progress Report In 2023, 57.3% of adolescents aged 13-15 had received human papilloma virus vaccine as recommended (HPV).

6. cdc.gov cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was approved by FDA for use in 2014. · The safety of Gardasil 9 was studied in clinical ...

7. gardasil9.com gardasil9.com/patient-pd/what-is-gardasil-9/safety-and-side-effects/

GARDASIL 9 safety and side effects GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, ...

8. fda.gov fda.gov/media/90064/download

Package Insert - GARDASIL 9 Safety and immunogenicity were assessed in individuals who completed a three-dose vaccination series with GARDASIL 9 and had previously completed a three-dose ...

9. merckvaccines.com merckvaccines.com/gardasil9/

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, ... GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40662677/

Adverse events following 9-valent human papillomavirus ... GARDASIL 9, a 9-valent HPV vaccine approved in 2014, is widely administered for the prevention of HPV-related malignancies.