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

Conditions

• Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex

ALL

Age

9 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 2, 2025

Status verified

Aug 2025

Primary completion

Mar 6, 2027

Completion

Mar 6, 2028

Study Design

Enrollment

1,836 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: 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.
• Experimental: Arm II (practice and provider)
  Practices receive components and trainings related to the practice and provider-level intervention on study.
• Active Comparator: Arm III (control)
  Practices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study.

Primary Outcome Measure

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

Central Contacts

• Robert Bednarczyk, PhD
  404-727-9713
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

Related Studies

• Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial
  Not Yet Recruiting · Fred Hutchinson Cancer Center · University Park, Pennsylvania