ECA-HPV App for Human Papillomavirus

Overseen By Jasmine Malave, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Prior participation, Inability to use system

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new smartphone app, the ECA-HPV App, designed to improve HPV vaccination rates. The app provides vaccine information and counseling through an interactive agent. The trial tests different app versions: one with clinic notifications, one with adolescent-focused features, and one with both. It suits English-speaking parents and guardians who can use a smartphone and have children aged 9-12 needing the HPV vaccine. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions for increasing HPV vaccination rates.

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 prior data suggests that the ECA-HPV App is safe for use?

Research shows that the ECA-HPV App is a tool designed to provide parents and teens with information about the HPV vaccine via a smartphone app. The app is not a medicine or vaccine, so it does not cause side effects like those. Instead, it serves as a guide to help users learn about and decide on receiving the HPV vaccine.

Since the app's purpose is to provide information and support, no reports of serious side effects have emerged from its use. Any safety concerns relate to the HPV vaccine, which the app promotes. Common side effects of the vaccine include redness, swelling, or pain at the injection site, and occasionally a mild fever. These effects are normal and typically resolve within a few days.

In summary, the app offers a safe way for families to learn about the HPV vaccine without causing the side effects associated with the vaccine itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ECA-HPV App because it offers a new way to boost HPV vaccination rates through technology. Unlike the standard care, which relies on traditional in-person counseling, the ECA-HPV App uses an interactive smartphone interface to engage parents and guardians with vaccine promotion and counseling. Some versions of the app even enable direct communication between users and clinic staff, making it easier to address concerns and logistical issues. Additionally, adolescent-focused features in certain app versions provide age-appropriate education and engaging activities like games, which could help increase interest and understanding among young users. Overall, this tech-driven approach aims to make vaccination promotion more engaging and accessible.

What evidence suggests that the ECA-HPV App could be effective for increasing HPV vaccination?

Research has shown that digital tools, such as the ECA-HPV app, can increase HPV vaccination rates. In this trial, participants will use different versions of the ECA-HPV app. Some versions include reminders and educational content, which studies indicate help increase vaccination rates. One version connects users with clinic staff to address concerns and reduce missed vaccination opportunities. Another version engages adolescents with age-appropriate content, such as games, to boost vaccination rates. Overall, these features have effectively encouraged people to complete their HPV vaccinations. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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)

Exclusion Criteria

Is not able to use the ECA-HPV system

Has already participated in the study before

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled Experimental Treatment 1 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 Disabled Experimental Treatment 1 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 Enabled Experimental Treatment 1 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 Enabled Experimental Treatment 1 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 Care Active Control 1 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.

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+

Published Research Related to This Trial

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic vaccines for cervical cancer: concept and clinical results. Fiander, A., Man, S., Borysiewicz, LK., et al.[2018]

HPV testing is crucial for women aged 21 to 64 with abnormal cervical cytology results, particularly those with atypical squamous cells of undetermined significance (ASC-US), and is also recommended for routine screening in women aged 30 to 64.

Several FDA-approved methods for HPV detection exist, including DNA and mRNA tests, with recent advancements allowing for specific detection of high-risk HPV types 16 and 18, enhancing cervical cancer management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus detection: testing methodologies and their clinical utility in cervical cancer screening. Laudadio, J.[2022]

HPV infection is extremely common, affecting about 80% of the population, and is a major cause of cervical cancer, which is the second most prevalent cancer in women globally.

HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers, while non-cancerous types like HPV-6 and HPV-11 are linked to over 90% of benign conditions such as genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The spectrum and clinical sequelae of human papillomavirus infection. Monk, BJ., Tewari, KS.[2019]

Recent advances in immunology have led to promising strategies for cervical cancer (CC) prevention and treatment, particularly through the use of HPV vaccines, such as the HPV type 16 vaccine, which has shown to reduce the incidence of HPV-16 infections and related cervical lesions in a phase III trial.

Immunotherapy approaches, including the use of dendritic cells pulsed with HPV-18 E7 oncoprotein, have shown potential in improving immune responses and achieving temporary remission in patients with metastatic cervical cancer, indicating a hopeful direction for future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preventive vaccines and immunotherapy clinical trials against cervical cancer]. Valdespino-Gómez, VM.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Approaches to Immunotherapy for HPV Associated Cancers. Bergot, AS., Kassianos, A., Frazer, IH., et al.[2022]

HPV-related cancers, including cervical and head and neck cancers, account for a significant portion of global cancer cases, highlighting the urgent need for effective vaccination strategies, especially since over 80% of people are exposed to HPV by age 50.

While prophylactic vaccines like Gardasil® and Cervarix® have successfully reduced HPV infections in young populations, there are currently no FDA-approved therapeutic vaccines for those already infected, indicating a critical gap in treatment options for HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Vaccines for HPV-Associated Malignancies. Smalley Rumfield, C., Roller, N., Pellom, ST., et al.[2020]

The study successfully produced a fluorescent HPV16 E7 protein (E7-GFP) in E. coli, which maintained its fluorescent properties when a linker was used, indicating its potential for use in protein vaccines against HPV16 infections.

Transfection of HEK-293T cells with the E7-GFP fusion protein resulted in stable fluorescence detectable for at least 24 hours, demonstrating its utility for in vitro detection and potential applications in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generation of the Fluorescent HPV16 E7 Protein for Detection of Delivery In vitro. Shahbazi, S., Bolhassani, A., Arashkia, A., et al.[2019]

A total of 3174 adverse events (AEs) were reported in children and adolescents aged 6-17 after receiving the HPV vaccine, with 191 (6%) classified as serious.

While these serious AEs raise concerns, further research is necessary to establish a direct link between these events and the HPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. Borja-Hart, NL., Benavides, S., Christensen, C.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of human papillomavirus vaccines. Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]

In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.

The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

A study involving 997,585 adolescent girls in Denmark and Sweden found no strong evidence linking the quadrivalent human papillomavirus (qHPV) vaccine to serious autoimmune, neurological, or venous thromboembolic adverse events.

While there were initial associations with Behcet's syndrome, Raynaud's disease, and type 1 diabetes, these were weak and not consistently related to the timing of vaccination, indicating that the qHPV vaccine is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. Arnheim-Dahlström, L., Pasternak, B., Svanström, H., et al.[2022]

The Gardasil® and Cervarix® vaccines are highly effective and safe in preventing cervical cancer caused by human papillomaviruses (HPV), which is the third most common cancer in women.

Current research is focused on developing more affordable second-generation HPV vaccines using different formulations, as the high cost of existing vaccines limits their global implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. Ribeiro-Müller, L., Müller, M.[2022]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06367699

Conversational Agents to Improve HPV Vaccine ... 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 ...

2. withpower.com withpower.com/trial/phase-papilloma-5-2024-373a4

ECA-HPV App for Human Papillomavirus 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433691/

The Effectiveness of Interventions Targeting Adolescents in ... HPV vaccine uptake increased following educational interventions in 11 out of the 14 studies that evaluated this outcome; studies presenting ...

4. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10929945&term=CA273208

Division of Cancer Control & Population Sciences - Grant Details We will evaluate ECA-HPV in a randomized controlled trial for HPV-vaccine eligible adolescents aged 9-12 to evaluate ECA-HPV, comparing usual care (UC) (n=175) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465035/

Clinical effectiveness of HPV vaccine by age at vaccination These data demonstrate that the full benefit of HPV vaccines may not be realized when administered at older ages. Continued and strengthened ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0893395224001492

The Clinicopathological and Molecular Characteristics of ... Human papillomavirus (HPV) has been universally recognized as a significant factor in the etiology of ECA. The International Endocervical Adenocarcinoma ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5762258/

International Endocervical Adenocarcinoma Criteria and ... There are also data reporting that the HPV genome can be differentially expressed in primary tumors, compared to metastases, and within ...

8. unicef.org unicef.org/eca/stories/what-know-about-hpv-vaccination

What to know about HPV vaccination The most common side effects may include redness, swelling or pain at the injection site, which should go away in a couple of days. Others include a mild fever, ...