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

NCT ID: NCT07104240

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2028-03-06

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

Receive vaccination information

Health Promotion and Education

Intervention Type: OTHER

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

Internet-Based Intervention

Intervention Type: OTHER

Receive access to TweenVax application

Arm II (practice and provider)

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

Group Type: EXPERIMENTAL

Health Promotion and Education

Intervention Type: OTHER

Receive components and trainings for the practice and provider levels

Arm III (control)

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

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Offer standard of care adolescent vaccination promotion practices

Interventions

Best Practice

Offer standard of care adolescent vaccination promotion practices

Intervention Type: OTHER

Educational Intervention

Receive vaccination information

Intervention Type: OTHER

Health Promotion and Education

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

Intervention Type: OTHER

Health Promotion and Education

Receive components and trainings for the practice and provider levels

Intervention Type: OTHER

Internet-Based Intervention

Receive access to TweenVax application

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

Eligibility 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

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Robert Bednarczyk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Bednarczyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert Bednarczyk, PhD

Role: CONTACT

rbednar@emory.edu

404-727-9713

Facility Contacts

Kyra Hester

Role: primary

kaheste@emory.edu

404-727-3956

Other Identifiers

NCI-2025-03575

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00009250

Identifier Type: OTHER

Identifier Source: secondary_id

RSPH6573-25

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R37CA234119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009250

Identifier Type: -

Identifier Source: org_study_id