564 Participants Needed

Intervention Strategies for Increasing HPV Vaccination Rates

(HPV MISTICS Trial)

LF
Overseen ByLindsay Fuzzell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the HPV vaccine treatment?

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, with over 90% efficacy in clinical studies. It also offers protection against additional cancer-causing HPV types, potentially preventing up to 93% of cervical cancer cases and a significant proportion of other HPV-related cancers.12345

Is the HPV vaccine safe for humans?

The HPV vaccines, including Gardasil 9, have been studied extensively for safety. Research shows that while some adverse events (unwanted effects) have been reported, the vaccines are generally considered safe for routine use in both males and females.678910

How does this treatment increase HPV vaccination rates?

This treatment is unique because it focuses on strategies like starting HPV vaccination at age 9 during well-child visits, using reminders, education, and scheduling future appointments to ensure vaccine completion. It also involves integrating the HPV vaccine with other adolescent vaccines and using strong provider recommendations to improve vaccination rates.1112131415

What is the purpose of this trial?

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.

Research Team

ST

Susan T Vadaparampil, PhD, MPH

Principal Investigator

Moffitt Cancer Center

SC

Shannon Christy, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Wave 2: Second Community Health CentersExperimental Treatment3 Interventions
Second group of community health centers to receive intervention
Group II: Wave 1: Initial Community Health CentersExperimental Treatment3 Interventions
Initial group of community health centers to receive intervention

Find a Clinic Near You

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+

Findings from Research

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

References

Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus. [2020]
Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]
Comparative efficacy of human papillomavirus vaccines: systematic review and network meta-analysis. [2023]
Spotlight on the 9-valent HPV vaccine. [2018]
Association between parent attitudes and receipt of human papillomavirus vaccine in adolescents. [2021]
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]
Safety of HPV vaccines in the age of nonavalent vaccination. [2018]
9.Czech Republicpubmed.ncbi.nlm.nih.gov
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]
Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Louisiana Physicians Are Increasing HPV Vaccination Rates. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Human Papillomavirus Vaccines. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
A retrospective and prospective look at strategies to increase adolescent HPV vaccine uptake in the United States. [2023]
14.United Statespubmed.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. [2023]
15.United Statespubmed.ncbi.nlm.nih.gov
Improving Human Papillomavirus Vaccine Use in an Integrated Health System: Impact of a Provider and Staff Intervention. [2022]
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