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Compensation: Varies

Number of Visits: Unknown

1836 Participants Needed

TweenVax for Cancer Prevention

Overseen ByRobert Bednarczyk, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Received HPV vaccine, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost HPV vaccination rates in adolescents by testing a new program, TweenVax, against standard promotion methods. The focus is on preventing HPV-related cancers by encouraging early vaccination, ideally by age 13. TweenVax provides education and tools for healthcare providers, parents, and young patients to improve vaccination messaging. The trial seeks children aged 9-12 who haven't started the HPV vaccine and are visiting a participating doctor's office. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance public health strategies for HPV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the TweenVax intervention is safe for improving HPV vaccination rates in adolescents?

Research has shown that HPV (human papillomavirus) vaccines are very safe. For over 15 years, studies have confirmed that these vaccines effectively prevent diseases caused by HPV. They offer long-lasting protection with a very low risk of serious side effects. Most side effects are mild, such as soreness at the injection site or a slight fever.

The TweenVax program supports the use of these safe vaccines but is not a vaccine itself. It aims to increase HPV vaccination rates by providing better education and recommendations. As a promotional tool rather than a medical treatment, TweenVax poses no safety concerns. Instead, it helps more people access and benefit from the safe and effective HPV vaccines available.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about TweenVax for cancer prevention because it integrates multiple levels of intervention, including practice, provider, parent, and patient engagement. Unlike the standard adolescent vaccination practices, TweenVax offers a comprehensive approach by involving parents and adolescents directly through an interactive application. This app delivers personalized vaccination information during clinical visits, aiming to enhance understanding and participation. By combining technology and education at multiple levels, TweenVax has the potential to improve vaccination rates and ultimately aid in cancer prevention more effectively than current standard practices.

What evidence suggests that this trial's interventions could be effective for improving HPV vaccination rates?

Research shows that increasing HPV vaccination rates can prevent many HPV-related cancers. Studies have found that widespread use of the HPV vaccine can greatly reduce cervical cancer cases. In this trial, the TweenVax program aims to increase HPV vaccine use by educating doctors, parents, and patients. Participants in Arm I will receive all TweenVax components and training at practice, provider, parent, and patient levels. This comprehensive approach is expected to be more effective than current methods in increasing vaccination rates among young people.¹ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Robert Bednarczyk, PhD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

The TweenVax trial is for adolescents who need the HPV vaccine, which can prevent certain types of cancer. The study aims to see if a special educational program (TweenVax) helps increase vaccination rates compared to usual ways of promoting vaccines.

Inclusion Criteria

PRACTICE-LEVEL: Must be community based primary care providers (pediatrics or family practice)

CHILD/ADOLESCENT: Seeking care from an enrolled practice during the study period

I have not received any HPV vaccine doses before my first study visit.

See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Practices receive TweenVax components and trainings related to practice, provider, staff, parent, and adolescent-level intervention

Duration not specified

Multiple visits (in-person)

Follow-up

Participants are monitored for initiation and completion of HPV vaccine by 13 years of age

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

TweenVax

Trial Overview This trial tests an intervention called TweenVax that includes education at different levels: practice, provider, parent, and patient. It's designed to teach best practices for vaccination promotion and provide clear information about the HPV vaccine.

How Is the Trial Designed?

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (practice and provider)Experimental Treatment1 Intervention

Practices receive components and trainings related to the practice and provider-level intervention on study.

Group II: Arm I (TweenVax, practice, provider, parent, patient level)Experimental Treatment3 Interventions

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.

Group III: Arm III (control)Active Control1 Intervention

Practices continue to offer standard of care adolescent vaccination promotion practices to adolescent patients on study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.reporter.nih.govreporter.nih.gov/project-details/11191586

Project Details - NIH RePORTEROur research team has developed and pilot-tested an intervention package – TweenVax – designed to improve HPV vaccine uptake at the practice-, provider-, and ...

2.clinicaltrials.govclinicaltrials.gov/study/NCT07104240

A Vaccine Promotion Package (TweenVax) to Improve ...This clinical trial compares the effect of a vaccine promotional intervention, TweenVax, to standard of care vaccination promotion practices on ...

3.withpower.comwithpower.com/trial/phase-human-papilloma-virus-related-carcinoma-4-2025-54aa0

TweenVax for Cancer PreventionThis N/A medical study run by Emory University is evaluating whether TweenVax will have tolerable side effects & efficacy for patients with Carcinoma.

4.dph.georgia.govdph.georgia.gov/document/document/evaluation-report-2017-2018/download

https://dph.georgia.gov/document/document/evaluati...Recent data show that 16.8 percent of cancer survivors report being current smokers and almost 31 percent report no leisure time physical activity (Georgia ...

5.cancer.govcancer.gov/news-events/cancer-currents-blog/2020/hpv-vaccine-prevents-cervical-cancer-sweden-study

Study Confirms HPV Vaccine Prevents Cervical Cancer - NCIWidespread HPV vaccine use dramatically reduces the number of women who will develop cervical cancer, a large study has shown.

6.cdc.govcdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness DataMore than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.

7.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC12320879/

Real-world safety of HPV vaccines over 18 y - PubMed CentralAlthough clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated ...

8.yokosuka.tricare.milyokosuka.tricare.mil/Portals/133/HPV%20Vaccine%20Information.pdf

HPV Vaccine Safety and EffectivenessHPV vaccination could prevent more than 90% of these cancers from ever developing. The vaccine is made from one protein from the virus and is ...

9.ctv.veeva.comctv.veeva.com/study/testing-rg1-vlp-vaccine-to-prevent-hpv-related-cancers

Testing RG1-VLP Vaccine to Prevent HPV-related CancersThis phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus ...

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