TweenVax: a program to increase HPV vaccination in 9–12-year-olds
TweenVax: A Comprehensive Practice-, Provider-, and Parent/Patient-Level Intervention to Improve Adolescent HPV Vaccination
This project tests whether the TweenVax program—education and messaging for clinics, providers, parents, and patients—helps more unvaccinated 9–12-year-olds start the HPV vaccine series than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1836 (estimated) |
| Ages | 9 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07104240 on ClinicalTrials.gov |
What this trial studies
This cluster-randomized trial assigns community pediatric and family practices to one of three arms: full TweenVax (practice, provider, parent and adolescent-level education with a tablet app), provider/practice-only components, or usual care. Practices must have sufficient patient volume and use electronic medical records or report to the state immunization registry so the team can track HPV vaccine initiation among 9–12-year-olds who have not yet received any HPV doses. The primary outcome is HPV vaccine initiation rates during the intervention with practices followed for up to one year after the intervention period. The intervention combines staff training, provider communication coaching, parent- and patient-facing messaging, and an internet-based TweenVax application used during clinical encounters.
Who should consider this trial
Good fit: Ideal candidates are unvaccinated 9–12-year-old children seeking care at participating community pediatric or family practice clinics.
Not a fit: Children who have already received any HPV vaccine dose, those outside the 9–12 age range, or those who do not receive care at an enrolled clinic are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase HPV vaccine starts and completion by age 13, lowering future rates of HPV-related cancers.
How similar studies have performed: Prior pilot work and broader evidence that strong provider recommendations and parent education improve HPV uptake support this approach, though multi-component clinic-level packages remain under active testing at scale.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Robert Bednarczyk, PhD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Robert Bednarczyk, PhD
- Email: rbednar@emory.edu
- Phone: 404-727-9713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.