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

NCT07104240 | Recruiting

• 5 other identifiers: STUDY00009250NCI-2025-03575RSPH6573-25P30CA138292R37CA234119
• Study Type: interventional
• Target: 1,836
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age

  Will do a direct comparison of rates in the intervention groups relative to the control group. However, if there is an imbalance in covariates between the arms, will then use multivariable regression, accounting for clinic-level clustering and key covariates. If needed, the initial regression model will be a log-binomial regression, to directly estimate relative risk; however, the final modeling choice will be dependent on the actual distribution of the data which may necessitate an alternative modeling method. Each intervention arm will be compared to the control arm independently, and analysis will be conducted separately for HPV vaccine series initiation and completion. Will model vaccination rates with associated 95% confidence intervals, and comparisons between intervention arms will be conducted by comparing confidence intervals.

  Up to 1 year follow-up

Secondary Outcomes (1)

• Rate of missed opportunities for vaccination

  Up to 1 year follow-up

Study Arms (3)

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

EXPERIMENTAL

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.

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

Arm II (practice and provider)

EXPERIMENTAL

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

Other: Health Promotion and Education

Arm III (control)

ACTIVE COMPARATOR

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

Other: Best Practice

Interventions

Best Practice OTHER

Offer standard of care adolescent vaccination promotion practices

Also known as: standard of care, standard therapy

Arm III (control)

Educational Intervention OTHER

Receive vaccination information

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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

Health Promotion and Education OTHER

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

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

Internet-Based Intervention OTHER

Receive access to TweenVax application

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

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Health Promotion

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Health Education

Study Officials

• Robert Bednarczyk, PhD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Bednarczyk, PhD

CONTACT

404-727-9713; rbednar@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 5, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): March 6, 2027
• Study Completion (Estimated): March 6, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

US (1)