1750 Participants Needed

ECA-HPV App for Human Papillomavirus

MP
CN
NP
JM
Overseen ByJasmine Malave, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Tufts Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ECA-HPV App treatment for human papillomavirus?

Research shows that immunotherapies targeting HPV proteins, like E6 and E7, are effective in treating HPV-related cervical cancers. This suggests that treatments focusing on these proteins can be beneficial in managing HPV infections.12345

Is the ECA-HPV App safe for humans?

The safety of HPV vaccines has been studied extensively, with some reports of adverse events (unwanted effects) in children and adolescents, but serious events are rare. More research is needed to fully understand these effects, but the vaccines are generally considered safe.678910

How does the ECA-HPV App treatment differ from other HPV treatments?

The ECA-HPV App treatment is unique because it likely involves a digital or app-based approach to managing HPV, which is different from traditional treatments like vaccines or medications. This app-based method may focus on education, monitoring, or supporting immune responses, offering a novel way to complement existing HPV prevention and treatment strategies.311121314

What is the purpose of this trial?

The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors.

Research Team

MP

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for individuals dealing with warts or human papillomavirus (HPV). The study aims to include a diverse group of participants, but specific eligibility criteria are not provided in the information given.

Inclusion Criteria

I am between 9 and 12 years old.
For adolescent participants: Has a smartphone or has access to parent/guardian's smartphone (that is able to support the ECA-HPV app)
For parent/guardian participants: Has adequate corrected vision to use the ECA-HPV system (based on their ability to go through the consent form)
See 8 more

Exclusion Criteria

Is not able to use the ECA-HPV system
Has already participated in the study before

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys using REDCap

1 week
1 visit (virtual)

Intervention

Participants use the ECA-HPV app and complete surveys after well child visits

16 months
3 visits (virtual)

Follow-up

Participants are monitored for HPV vaccination series completion and satisfaction with the intervention

4 weeks

Treatment Details

Interventions

  • ECA-HPV App
Trial Overview The trial is testing an app called ECA-HPV in different configurations: with clinic notifications and adolescent functions either enabled or disabled. It compares these against usual care over 16 months to see if they increase HPV vaccine uptake and satisfaction.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: ECA-HPV App with Clinic Notification and Adolescent Functions EnabledExperimental Treatment1 Intervention
Participants will receive the full ECA-HPV (Embodied Conversational Agent adapted for this project) system on their smartphone app, which includes both the clinic notification and adolescent functions enabled. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit.
Group II: ECA-HPV App with Clinic Notification and Adolescent Functions DisabledExperimental Treatment1 Intervention
The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. The clinic notification feature is disabled on the app. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit.
Group III: ECA-HPV App with Clinic Notification Function EnabledExperimental Treatment1 Intervention
The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit.
Group IV: ECA-HPV App with Adolescent Function EnabledExperimental Treatment1 Intervention
The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. The clinic notification feature is disabled on both the parent/guardian and adolescent apps. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit.
Group V: Usual CareActive Control1 Intervention
An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Both parent/guardian and adolescent participants do not have access to the ECA-HPV app. Adolescent participants will receive usual standard of care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials
264
Recruited
264,000+

Boston Medical Center

Collaborator

Trials
410
Recruited
890,000+

Northeastern University

Collaborator

Trials
103
Recruited
72,600+

Findings from Research

While clinical trials have shown that HPV vaccines are highly effective, their effectiveness in the general population is still not fully understood, highlighting the need for further research.
A comprehensive review of HPV-related clinical outcomes suggests that tracking these outcomes at the population level is crucial for evaluating the real-world effectiveness of HPV vaccines, as many large trials are nearing completion.
Evaluating the impact of human papillomavirus vaccines.Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]
Prophylactic HPV vaccines using virus-like particles can significantly prevent cervical cancer caused by HPV infections, but they do not treat existing infections or prevent their progression to cancer.
Recent advances in immunotherapy for HPV-associated cancers show promise, with clinical trials indicating successful treatment of HPV lesions, suggesting new potential strategies for managing HPV-related malignancies.
New Approaches to Immunotherapy for HPV Associated Cancers.Bergot, AS., Kassianos, A., Frazer, IH., et al.[2022]
HPV infection, particularly genotypes 16 and 18, is linked to cervical cancer, with the E6 and E7 proteins serving as key tumor markers and targets for immunotherapy.
Recent Phase I/II clinical trials have shown promising results in inducing specific cellular immune responses against HPV E6 and E7, highlighting the potential for developing effective vaccines for cervical cancer treatment.
Therapeutic vaccines for cervical cancer: concept and clinical results.Fiander, A., Man, S., Borysiewicz, LK., et al.[2018]

References

Evaluating the impact of human papillomavirus vaccines. [2009]
New Approaches to Immunotherapy for HPV Associated Cancers. [2022]
Therapeutic vaccines for cervical cancer: concept and clinical results. [2018]
Therapeutic Vaccines for HPV-Associated Malignancies. [2020]
Generation of the Fluorescent HPV16 E7 Protein for Detection of Delivery In vitro. [2019]
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]
Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]
[Human papillomavirus vaccine register]. [2013]
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]
Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Human papillomavirus detection: testing methodologies and their clinical utility in cervical cancer screening. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
The spectrum and clinical sequelae of human papillomavirus infection. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Prophylactic papillomavirus vaccines. [2022]
[Preventive vaccines and immunotherapy clinical trials against cervical cancer]. [2018]
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