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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Protect Me 4, designed to help parents and healthcare providers improve discussions about the HPV vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant). The researchers aim to determine if this app can increase the number of children starting the HPV vaccine series, potentially preventing thousands of cancer cases each year. Participants will use the app alone, with additional support, or receive standard care. Parents of children aged 11-12, particularly those who speak and read English, are eligible to participate. As an unphased trial, this study provides a unique opportunity for parents to contribute to innovative research that could enhance public health communication and increase vaccine uptake.

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 the Protect Me 4 app is safe for increasing HPV vaccine uptake?

Research has shown that the HPV vaccine is very safe, with studies indicating that unwanted side effects are rare. For example, in Australia, after administering nine million doses of a specific HPV vaccine, there were only about 39.8 reports of side effects per 100,000 doses. This indicates that most people tolerate the vaccine well.

Deaths related to the HPV vaccine are extremely rare. Of all the vaccines administered, only 0.6% of reports involved deaths, a very small number. The CDC continues to recommend the vaccine for preteen girls and boys to help prevent certain types of cancer.

Specific safety data for the Protect Me 4 app and its support feature is not available. However, as the app serves as a tool to facilitate discussions about vaccines, it does not pose health risks like a medication might. The app aims to make conversations about the vaccine easier and more informed, potentially supporting safer vaccination practices by ensuring parents have all the necessary information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost HPV vaccination rates among young adolescents. Unlike traditional approaches that rely solely on healthcare providers for vaccination education and administration, this trial introduces the "Protect Me 4" app, designed to engage parents and improve vaccine uptake. By incorporating technology, the app provides tailored information and reminders, making it more convenient for parents to stay informed and proactive about their child's vaccination schedule. Additionally, when combined with external quality improvement support, the app may enhance the effectiveness of existing healthcare practices, offering a potentially powerful tool to increase vaccination rates and prevent HPV-related diseases.

What evidence suggests that this trial's treatments could be effective for increasing HPV vaccine uptake?

Research has shown that the HPV vaccine effectively prevents certain types of human papillomavirus infections, reducing them by about 90%, including genital warts. One study found that even one or more doses of the vaccine can prevent 54% of HPV-related diseases. This trial tests the Protect Me 4 app as a tool to help parents and health providers communicate more effectively about the vaccine, aiming to increase vaccination rates. Some participants will use the Protect Me 4 app alone, while others will use it with external quality improvement support. Similar tools have successfully helped more people start and complete their HPV vaccine series, which is important for preventing cancers caused by HPV. ^{2 6 7 8 9}

Who Is on the Research Team?

Stephanie Staras, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Adolescents/Parents/Providers willing to consent to participation

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459466/

A Review of Quality Improvement Methodologies This paper aims to review published quality improvement (QI) methodologies on interventions to improve HPV vaccine uptake among adolescents.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520301236

Interventions to increase uptake of Human Papillomavirus ... This systematic review assesses the effectiveness of interventions to increase HPV vaccine uptake, measured as vaccine series initiation and series completion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12533954/

“It really is HPV that's pulling us down”: Findings from a ... The human papillomavirus (HPV) vaccine could prevent 37000 HPV-related cancers annually in the U.S. yet uptake is suboptimal.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836046

Multilevel Intervention and Human Papillomavirus ... A combination of parent reminder/recall letters and health care professional audit/feedback was associated with improved HPV vaccine uptake among most children ...

5. scholarworks.uark.edu scholarworks.uark.edu/cgi/viewcontent.cgi?article=1034&context=nursstudent

Increasing Human Papillomavirus Vaccine Uptake in Primary ... The 4 Pillars™ Program has shown success in increasing vaccination rates of other vaccines and it is expected to improve the HPV vaccination rate as well.

6. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01CA297324&arg_ProgOfficeCode=110

Award Information | HHS TAGGS Supporting Informed Parental Decisions on HPV Vaccination through Safe and Personalized AI-Driven Conversations · Award Number: R01CA297324 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8437543/

Prioritizing and implementing HPV vaccination quality ... Human papillomavirus (HPV) vaccination could prevent most of the ~34,000 HPV-attributable cancers diagnosed annually in the US, but uptake remains suboptimal.

8. montefioreeinstein.org montefioreeinstein.org/news/2025/09/29/study-shows-hpv-vaccine-protects-vaccinated-and-unvaccinated-women

Study Shows HPV Vaccine Protects ... Programs & Services. Division of General Obstetrics & Gynecology; Division of Maternal-Fetal Medicine

9. nature.com nature.com/articles/s41598-025-03145-x

Barriers and strategies to enhance HPV vaccine uptake in ... This study explored the barriers of HPV vaccine uptake and identified strategies to improve vaccination rates among female adolescents infected ...