HPV Vaccination App for Increasing HPV Vaccine Uptake

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Staras, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Florida

No Placebo Group

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).

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

Adolescents/Parents that can read and speak English

Exclusion Criteria

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

Adolescents/Parents that can NOT read and speak English

I am willing to consent to participate in the study.

Treatment Details

Interventions

• HPV Vaccine (Cancer Vaccine)
• Protect Me 4 Application Alone (Behavioral Intervention)
• Protect Me 4 Application + External Quality Improvement Support (Behavioral Intervention)

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 Canada, Switzerland for the following indications:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Florida Gainesville, FL

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE