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Recruiting NCT07104240

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

No phase Interventional Human Papillomavirus-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Educational Intervention, Health Promotion and Education, Health Promotion and Education.
Who it may be relevant to
Registry conditions: Human Papillomavirus-Related Carcinoma. Basic parameters: from 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age [Time frame: Up to 1 year follow-up]
Secondary outcome measures (1)
  • Rate of missed opportunities for vaccination [Time frame: Up to 1 year follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Emory University Hospital/Winship Cancer Institute — Atlanta

Identifiers

NCT: NCT07104240 · STUDY00009250 · NCI-2025-03575 · STUDY00009250 · RSPH6573-25 · P30CA138292 · R37CA234119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗