NCT07104240 · Emory University
A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial
What this study is about
This clinical trial compares the effect of a vaccine promotional intervention, TweenVax, to the usual treatment vaccination promotion practices on rates of human papillomavirus (HPV) vaccination in adolescents.
View original scientific description
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2025 · Source of record for eligibility and locations