HPV Vaccination App for Increasing HPV Vaccine Uptake

Overseen By Marta Hansen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Age, Consent, Language, others

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

Compensation: Varies

Number of Visits: Unknown

1296 Participants Needed

Trial Summary

What is the purpose of this trial?

Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines. The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose).

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 HPV vaccines, like Gardasil 9, are highly effective in preventing infections and diseases caused by certain types of HPV, including cervical cancer and genital warts. Clinical trials have demonstrated nearly 100% efficacy in preventing persistent infections and precancerous lesions in vaccinated individuals. ^{1 2 3 4 5}

Is the HPV vaccine generally safe for humans?

The HPV vaccines, including Gardasil 9, have been studied for safety, and while some adverse events (unwanted effects) have been reported, they are generally considered safe based on data from various safety monitoring systems. ^{6 7 8 9 10}

How is the HPV Vaccination App treatment different from other HPV vaccine treatments?

The HPV Vaccination App treatment is unique because it combines the use of the Gardasil 9 vaccine with a digital application, Protect Me 4, which may include external quality improvement support to increase vaccine uptake. This approach is novel as it integrates technology to enhance vaccination rates, unlike traditional methods that rely solely on vaccine administration. ^{1 2 7 11 12}

Research Team

Stephanie Staras, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for parents of adolescents aged 11-12, and healthcare providers working with this age group. Participants must be able to read and speak English and give consent to join the study.

Inclusion Criteria

I am the parent of an 11-12 year old child.

Adolescents/Parents/Providers willing to consent to participation

I work with teenagers who are the right age for this study.

Exclusion Criteria

I am not within the age range specified for adolescents in this study.

I am willing to consent to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Period

Initial data collection and baseline assessment of vaccination rates

3 months

Data collection from Medicaid and CHIP claims and Florida Immunization Registry

Implementation

Intervention clinics receive Protect Me 4 app and external quality improvement support

3 months

Regular monitoring and support visits

Maintenance

Intervention clinics continue using Protect Me 4 app without external support

3 months

Ongoing data collection and monitoring

Follow-up

Participants are monitored for effectiveness of the intervention after the main trial phases

3 months

Treatment Details

Interventions

• HPV Vaccine
• Protect Me 4 Application Alone
• Protect Me 4 Application + External Quality Improvement Support

Trial Overview The trial is testing an app called Protect Me 4, designed to improve conversations about HPV vaccines between parents/providers and increase vaccine uptake. It will compare the use of the app with and without additional quality support.

Participant Groups

Group I: Health Care Provider at Control Clinic Active Control 1 Intervention

Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.

Group II: Health Care Provider Active Control 2 Interventions

Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.

Group III: Adolescents at Intervention clinics Active Control 1 Intervention

Adolescents between 11-12 years of age. Adolescent vaccination data is used in the study, adolescents will assent to participate. The parents, however, use the HIT system.

Group IV: Adolescents at Control Clinic Active Control 1 Intervention

Parents of 11-12 year old children who visit participating control clinics during study period.

Group V: Parents Active Control 2 Interventions

Parents of 11-12 year old children who visit participating interventional clinics during study period.

HPV Vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in European Union as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Canada as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Switzerland as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

Prophylactic HPV vaccines, particularly the quadrivalent vaccine targeting types 6, 11, 16, and 18, have shown very high efficacy in preventing HPV infections and associated diseases, including high-grade cervical lesions and genital warts, in diverse populations including young women and men.

The vaccines have a favorable safety profile and are being introduced globally to reduce HPV-related morbidity and mortality, with the ultimate goal of implementing cervical cancer control programs, especially in less-developed countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV prophylactic vaccination: The first years and what to expect from now. Villa, LL.[2022]

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]

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 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]

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]

In a study of 316 females who reported suspected severe adverse reactions to the HPV vaccine, it was found that these individuals had significantly higher health care-seeking behavior in the two years prior to vaccination compared to a control group of over 163,000 individuals.

The cases showed increased consultations for various health issues, including psychological support and musculoskeletal problems, suggesting that pre-existing health conditions may influence perceptions of vaccine safety and should be considered when evaluating vaccine safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study. Mølbak, K., Hansen, ND., Valentiner-Branth, P.[2019]

The introduction of the quadrivalent vaccine Gardasil and the bivalent vaccine Cervarix has significantly advanced the prevention of HPV-related diseases, including various cancers and benign conditions like genital warts.

A new multivalent vaccine, Gardasil 9, has been approved and shows promise in providing broader protection against nine HPV subtypes, with ongoing efforts to improve vaccine accessibility and reduce production costs, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. Fruscalzo, A., Londero, AP., Bertozzi, S., et al.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Prophylactic HPV vaccines: reducing the burden of HPV-related diseases. [2007]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine(Gardasil®) in the prevention of premalignant genital lesions, genital cancer, and genital warts in women. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

HPV prophylactic vaccination: The first years and what to expect from now. [2022]

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

Cervical cancer vaccination indications, efficacy, and side effects. [2015]

5. Cyprus pubmed.ncbi.nlm.nih.gov

Primary prevention of cervical cancer: prophylactic human papillomavirus vaccines. [2012]

6. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. [2018]

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

Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study. [2019]

11. Australia pubmed.ncbi.nlm.nih.gov

Low rates of free human papillomavirus vaccine uptake among young women. [2018]

12. Italy pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. [2016]