Human Papillomavirus-Related CarcinomaNCT07104240
A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial
A study testing Best Practice, Educational Intervention and Health Promotion and Education in people with Human Papillomavirus-Related Carcinoma, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma
- What is being tested?
- Best Practice, Educational Intervention and Health Promotion and Education
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,836 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2025to 6 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Kyra Hester, 404-727-3956, kaheste@emory.edu
Robert Bednarczyk, PhD
About this study
Official title: TweenVax: A Comprehensive Practice-, Provider-, and Parent/Patient-Level Intervention to Improve Adolescent HPV Vaccination
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Human Papillomavirus-Related Carcinoma
- Being tested
- Best Practice, Educational Intervention, Health Promotion and Education, Internet-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Offer standard of care adolescent vaccination promotion practices
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive vaccination information
Health Promotion and EducationOther
Receive all TweenVax components and trainings for the practice, providers and staff, parents and adolescents
Health Promotion and EducationOther
Receive components and trainings for the practice and provider levels
Internet-Based InterventionOther
Receive access to TweenVax application
| Study group | Role | What they receive |
|---|---|---|
| Arm I (TweenVax, practice, provider, parent, patient level) | Experimental | 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. Receives: Other: Educational Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention |
| Arm II (practice and provider) | Experimental | Practices receive components and trainings related to the practice and provider-level intervention on study. Receives: Other: Health Promotion and Education |
| Arm III (control) | Active comparator | Practices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age
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.
Measured: Up to 1 year follow-up
Secondary outcomes (1)
Rate of missed opportunities for vaccination
Will assess the total number of healthcare encounters, classifying them as whether the adolescent was eligible for HPV vaccine at the time of the visit. Eligible visits with no vaccine administered, when a vaccine could have been administered based on eligibility, will be considered a missed opportunity. Will compare the mean number of missed opportunities per arm using analysis of variance, and the proportion of adolescents with at least one missed opportunity per arm using Fisher's exact test.
Measured: Up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start2 May 2025
- Primary completion6 Mar 2027 (estimated)
- Study completion6 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,836 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Robert Bednarczyk, Emory University
- Investigators
- Robert Bednarczyk, PhD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104240
- Sponsor's protocol ID
- STUDY00009250
- Other IDs
- NCI-2025-03575, STUDY00009250, RSPH6573-25, P30CA138292, R37CA234119
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TweenVax: A Comprehensive Practice-, Provider-, and Parent/Patient-Level Intervention to Improve Adolescent HPV Vaccination
- ClinicalTrials.gov ID
- NCT07104240
- Acronym / sponsor ID
- STUDY00009250
- Conditions
- Human Papillomavirus-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,836 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 May 2025 (actual)
- Primary completion
- 6 Mar 2027 (estimated)
- Study completion
- 6 Mar 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (TweenVax, practice, provider, parent, patient level) | Experimental | Other: Educational Intervention, Other: Health Promotion and Education, Other: Internet-Based InterventionPractices 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 (practice and provider) | Experimental | Other: Health Promotion and EducationPractices receive components and trainings related to the practice and provider-level intervention on study. |
| Arm III (control) | Active comparator | Other: Best PracticePractices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyOffer standard of care adolescent vaccination promotion practices | Other | Arm III (control) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive vaccination information | Other | Arm I (TweenVax, practice, provider, parent, patient level) |
| Health Promotion and EducationReceive all TweenVax components and trainings for the practice, providers and staff, parents and adolescents | Other | Arm I (TweenVax, practice, provider, parent, patient level) |
| Health Promotion and EducationReceive components and trainings for the practice and provider levels | Other | Arm II (practice and provider) |
| Internet-Based InterventionReceive access to TweenVax application | Other | Arm I (TweenVax, practice, provider, parent, patient level) |
Primary outcome
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.
1 secondary outcome
Rate of missed opportunities for vaccination
Time frame: Up to 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bednarczyk, PhD principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Health Promotion and Education in people with Human Papillomavirus-Related Carcinoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Bednarczyk, PhD (404-727-9713, rbednar@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation and completion of human papillomavirus (HPV) vaccine by 13 years of age (time frame: Up to 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.