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

Emory University

Status: Enrolling

Conditions: Human Papillomavirus-Related Carcinoma

Treatments: Other: Best Practice; Other: Health Promotion and Education; Other: Educational Intervention; Other: Internet-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07104240

RSPH6573-25 (Other Identifier)

STUDY00009250 (Other Identifier)

P30CA138292 (U.S. NIH Grant/Contract)

NCI-2025-03575 (Registry Identifier)

R37CA234119 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,836 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,836 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Internet-Based Intervention

Other: Health Promotion and Education

Other: Educational Intervention

Other: Health Promotion and Education

Arm II (practice and provider)

Experimental group

Description:

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

Treatment:

Other: Health Promotion and Education

Other: Health Promotion and Education

Arm III (control)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice