NCT07104240

A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial

TweenVax: A Comprehensive Practice-, Provider-, and Parent/Patient-Level Intervention to Improve Adolescent HPV Vaccination

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,836 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 9 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To test the expanded and revised TweenVax intervention package based on pilot study findings and formative research evaluating best practices and deficiencies observed during adolescent healthcare encounters. OUTLINE: Pediatric practices are randomized to 1 of 3 arms. ARM I: 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. ARM II: Practices receive components and trainings related to the practice and provider-level intervention on study. ARM III: Practices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study. After completion of study intervention, practices are followed for up to 1 year.

Conditions

• Human Papillomavirus-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Offer standard of care adolescent vaccination promotion practices
OTHER	Educational Intervention	Receive vaccination information
OTHER	Health Promotion and Education	Receive all TweenVax components and trainings for the practice, providers and staff, parents and adolescents
OTHER	Health Promotion and Education	Receive components and trainings for the practice and provider levels
OTHER	Internet-Based Intervention	Receive access to TweenVax application

Timeline

• Start date: 2025-05-02
• Primary completion: 2027-03-06
• Completion: 2028-03-06
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States