Recruiting

TweenVax

Sponsor:

Emory University

Code:

NCT07104240

Conditions

Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

Interventions

Best Practice

Educational Intervention

Health Promotion and Education

Health Promotion and Education

Internet-Based Intervention

Study Details

Brief summary:

This clinical trial compares the effect of a vaccine promotional intervention, TweenVax, to standard of care vaccination promotion practices on rates of human papillomavirus (HPV) vaccination in adolescents. HPV vaccination has been identified as a priority for cancer prevention and control by the Cancer Moonshot Blue Ribbon Panel, which estimated that increasing HPV vaccination rates can prevent 400,000 HPV-related cancers in the next 5-10 years. The goal is for HPV vaccinations to be completed by the age of 13. It has been estimated that only about 16% of adolescents were fully up to date with HPV vaccines by age 13. Strong and consistent provider recommendations have been shown to play an important role in the uptake of vaccines. In addition, education and information received by parents may improve the strength of recommendations by providers. The TweenVax intervention includes practice, provider, parent and patient level education to teach best practices, help with vaccine messaging, and give correct and easy to understand information to parents. Providing practice, provider and parent level access to TweenVax may be more effective than current vaccine promotion practices in improving HPV vaccination rates in adolescents.

Conditions

Human Papillomavirus-Related Carcinoma

Study ID

NCT07104240

Start date

May 2, 2025

Status verified date

Aug, 2026

Completion date

Mar 6, 2028

Anticipated

Primary completion date

Mar 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • PRACTICE-LEVEL: Must be community based primary care providers (pediatrics or family practice)
  • PRACTICE-LEVEL: Are willing to be part of the study
  • PRACTICE-LEVEL: Have sufficient patient population to support 51 adolescents aged 9-12 years over approximately a 9-month period
  • PRACTICE-LEVEL: Utilize an electronic medical records system and/or report to the state Immunization Information System (IIS)
  • CHILD/ADOLESCENT: Aged 9-12 years
  • CHILD/ADOLESCENT: Seeking care from an enrolled practice during the study period
  • CHILD/ADOLESCENT: Have not received any doses of HPV vaccine by the time of their first visit during the study period

Study Design

Enrollment

1836 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm I (TweenVax, practice, provider, parent, patient level)

Practices receive all TweenVax components and trainings related to the practice, provider and staff, parent and adolescent-level intervention. Parents receive access to the TweenVax application and receive TweenVax vaccination information using the provided tablet during clinical encounters on study.

experimental: Arm II (practice and provider)

Practices receive components and trainings related to the practice and provider-level intervention on study.

active comparator: Arm III (control)

Practices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study.

Interventions

Best Practice

Offer standard of care adolescent vaccination promotion practices

Educational Intervention

Receive vaccination information

Health Promotion and Education

Receive all TweenVax components and trainings for the practice, providers and staff, parents and adolescents

Health Promotion and Education

Receive components and trainings for the practice and provider levels

Internet-Based Intervention

Receive access to TweenVax application

Primary outcome measure

  • Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age [ Time Frame: Up to 1 year follow-up ]

Central Contacts and Locations

Central contacts

Robert Bednarczyk, PhD

404-727-9713rbednar@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Robert Bednarczyk, PhD

More Information

Sponsor

Emory University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-03.