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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age [Срок оценки: Up to 1 year follow-up]

Вторичные конечные точки (1)

• Rate of missed opportunities for vaccination [Срок оценки: Up to 1 year follow-up]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Emory University Hospital/Winship Cancer Institute — Atlanta

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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