ECA-HPV App for Human Papillomavirus
Recruiting in Palo Alto (17 mi)
Overseen byMichael Paasche-Orlow, MD, MPH
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tufts Medical Center
Disqualifiers: Prior participation, Inability to use system
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
311121314Eligibility 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)
+9 more
Exclusion Criteria
Is not able to use the ECA-HPV system
Has already participated in the study before
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Boston Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Tufts Medical CenterLead Sponsor
Boston Medical CenterCollaborator
Northeastern UniversityCollaborator
References
Evaluating the impact of human papillomavirus vaccines. [2009]While two prophylactic HPV vaccines have been proven notably efficacious in clinical trials, the effectiveness of these vaccines at the population level remains to be evaluated. To lay the foundation for understanding the strengths and limitations of different endpoints for future effectiveness research, we present a comprehensive review of HPV-related clinical outcomes, including: (i) HPV type-specific positivity and persistence, (ii) Pap diagnoses (ASC-US, LSIL, and HSIL), (iii) histologic cervical cancer precursor lesions (i.e., CIN1, CIN2, and CIN3), (iv) invasive cervical cancer (ICC), (v) anogenital warts, (vi) recurrent respiratory papillomatosis (RRP), and (vii) other HPV-associated cancers (vulvar, vaginal, anal, penile, and oropharyngeal). While research on the vaccines' effects on these HPV clinical outcomes in the general population is presently limited, numerous large trials will soon be completed, making a priori discussion of these potential outcomes especially urgent. Furthermore, population level systems to track HPV-associated clinical outcomes may need to be developed for HPV vaccine effectiveness evaluation.
New Approaches to Immunotherapy for HPV Associated Cancers. [2022]Cervical cancer is the second most common cancer of women worldwide and is the first cancer shown to be entirely induced by a virus, the human papillomavirus (HPV, major oncogenic genotypes HPV-16 and -18). Two recently developed prophylactic cervical cancer vaccines, using virus-like particles (VLP) technology, have the potential to prevent a large proportion of cervical cancer associated with HPV infection and to ensure long-term protection. However, prophylactic HPV vaccines do not have therapeutic effects against pre-existing HPV infections and do not prevent their progression to HPV-associated malignancy. In animal models, therapeutic vaccines for persisting HPV infection can eliminate transplantable tumors expressing HPV antigens, but are of limited efficacy in inducing rejection of skin grafts expressing the same antigens. In humans, clinical trials have reported successful immunotherapy of HPV lesions, providing hope and further interest. This review discusses possible new approaches to immunotherapy for HPV associated cancer, based on recent advances in our knowledge of the immunobiology of HPV infection, of epithelial immunology and of immunoregulation, with a brief overview on previous and current HPV vaccine clinical trials.
Therapeutic vaccines for cervical cancer: concept and clinical results. [2018]Human papillomavirus (HPV) infection is associated with transformation and clonal expansion of infected epithelial cells, resulting in the production of a benign growth, i.e. a wart. Recently, however, HPV has emerged as the primary causative agent of cervical carcinoma, malignancy being associated with the presence of the viral genome (predominantly genotypes 16 and 18) in cancerous cells. The only HPV proteins reliably expressed in neoplastic lesions are the 'oncogenic' E6 and E7 proteins, that serve both as tumour-specific markers and potential targets for immunotherapeutic intervention. As intracellular (nuclear) proteins, the E6 and E7 gene products may be hidden from the humoral immune response. Attention has thus focused on the generation of a vaccine capable of inducing or stimulating a cellular immune response to HPV 16 and HPV 18 E6 and E7. Vaccine development has been constrained by the absence of an appropriate animal model, the oncogenic nature of E6 and E7 and technical difficulties associated with detection of cytotoxic T cell responses to these antigens. Despite these difficulties, vaccine strategies have now been devised based on immunisation with synthetic peptide, whole protein and a vaccinia virus recombinant. Phase I/II human clinical trials have been initiated, and preliminary results have demonstrated the induction of specific cellular immune responses after immunisation. The HPV-associated neoplasia in cervical cancer represents an excellent target for therapeutic intervention because the tumour-associated antigens are so clearly defined. As such, it provides an appropriate model for establishing the general principles of cancer immunotherapy in humans.
Therapeutic Vaccines for HPV-Associated Malignancies. [2020]Human papillomavirus (HPV)-related malignancies are responsible for almost all cases of cervical cancer in women, and over 50% of all cases of head and neck carcinoma. Worldwide, HPV-positive malignancies account for 4.5% of the global cancer burden, or over 600,000 cases per year. HPV infection is a pressing public health issue, as more than 80% of all individuals have been exposed to HPV by age 50, representing an important target for vaccine development to reduce the incidence of cancer and the economic cost of HPV-related health issues. The approval of Gardasil® as a prophylactic vaccine for high-risk HPV 16 and 18 and low-risk HPV6 and 11 for people aged 11-26 in 2006, and of Cervarix® in 2009, revolutionized the field and has since reduced HPV infection in young populations. Unfortunately, prophylactic vaccination does not induce immunity in those with established HPV infections or HPV-induced neoplasms, and there are currently no therapeutic HPV vaccines approved by the US Food and Drug Administration. This comprehensive review will detail the progress made in the development of therapeutic vaccines against high-risk HPV types, and potential combinations with other immunotherapeutic agents for more efficient and rational designs of combination treatments for HPV-associated malignancies.
Generation of the Fluorescent HPV16 E7 Protein for Detection of Delivery In vitro. [2019]Immunotherapies targeting the human papillomavirus (HPV) oncogenic proteins, E6 and E7, are effective to treat HPV-associated cervical malignancies.
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.
Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]Recent news reports have linked the human papillomavirus (HPV) vaccine to serious adverse events (AEs) in children and adolescents. We used the Vaccine Adverse Event Reporting System (VAERS) database to extract postmarketing AEs reported in patients who received the vaccine. Since approval of the HPV vaccine in the US, 3174 AEs occurring in children and adolescents (aged 6-17 y) have been reported to the VAERS. Of these, 191 (6%) were deemed to be serious. Although these AEs are of significant concern, more research is required before they can be directly correlated with the vaccine.
[Human papillomavirus vaccine register]. [2013]We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. [2022]To assess the risk of serious adverse events after vaccination of adolescent girls with quadrivalent human papillomavirus (qHPV) vaccine.
Human papillomavirus detection: testing methodologies and their clinical utility in cervical cancer screening. [2022]Human papillomavirus (HPV) is a well-studied etiologic agent for cervical cancer dysplasia and neoplasia. HPV E6 and E7 viral proteins drive oncogenesis by blocking the activity of pRB and p53, respectively. Consensus screening guidelines focus on appropriate use of both cervical cytology and HPV testing to reduce the morbidity and mortality associated with cervical cancer. HPV testing is indicated for women aged 21 to 64 years with atypical squamous cells of undetermined significance (ASC-US) on cytology. In women aged 30 to 64, testing is also indicated for routine screening in conjunction with cervical cytology. Various methods are available for HPV detection and several Food and Drug Administration-approved assays are on the market using either signal or target amplification methodologies. Most of the approved tests target DNA, but tests for mRNA detection are also available. Recently, assays for type specific detection of HPV types 16 and 18 have been Food and Drug Administration approved, and the use of genotyping has been incorporated into management algorithms. HPV testing can be performed on liquid-based cytology samples and options for automation are available making the introduction of HPV testing into many pathology laboratories possible.
The spectrum and clinical sequelae of human papillomavirus infection. [2019]Infection with the human papillomavirus (HPV) is the most common sexually transmitted disease afflicting approximately 80% of the population. HPV infection is an essential factor in cervical carcinogenesis and cervical carcinoma is the second most common cause of cancer among women worldwide. In addition to cervical cancer, other malignancies in both men and women such as esophageal, oropharyngeal, and anal cancer have been causally associated with this virus. Other gender-specific HPV-related cancers include penile, vulvar and vaginal cancer. HPV-16 is the most common HPV type associated with a malignant phenotype regardless of organ of origin. HPV-16 together with HPV-18 accounts for approximately 70% of cervical cancers. Other non-oncogenic HPV types including HPV types 6 and 11 are associated with over 90% of benign HPV-related lesions such as genital warts and juvenile respiratory papillomatosis.
Prophylactic papillomavirus vaccines. [2022]Human papillomaviruses (HPV) are the causative agents of cervical cancer, the third most common cancer in women. The development of prophylactic HPV vaccines Gardasil® and Cervarix® targeting the major oncogenic HPV types is now the frontline of cervical cancer prevention. Both vaccines have been proven to be highly effective and safe although there are still open questions about their target population, cross-protection, and long-term efficacy. The main limitation for a worldwide implementation of Gardasil® and Cervarix® is their high cost. To develop more affordable vaccines research groups are concentrated in new formulations with different antigens including capsomeres, the minor capsid protein L2 and DNA. In this article we describe the vaccines' impact on HPV-associated disease, the main open questions about the marketed vaccines, and current efforts for the development of second-generation vaccines.
[Preventive vaccines and immunotherapy clinical trials against cervical cancer]. [2018]Cervical cancer (CC) is a public health problem among women worldwide, especially in emerging nations. To improve CC control, new adjuvant therapeutic strategies are required. Advances in immunology, genomics and proteomics have accelerated our understanding of the genetic and cellular basis of many cancer types. CC is a member of virus-related neoplasms and its initiation and promotion is associated with persistent infection of oncogenic human papillomavirus. During viral infection and associated-transforming developing lesions, the HPVs co-express non-structural and structural proteins. These early or late proteins are the antigenic target of the immune response. The intervention to stimulate the humoral or cellular immune anti-HPV response is the objective of the immunoprevention and immunotherapy against CC. Recently in a controlled phase III trial of HPV type 16 vaccine using virus-like particles of L1 capsid of HPV-16, the incidence was reduced of both HPV-16 infection and HPV-16-related cervical intraepithelial neoplasia. Although preliminary results of immunotherapy clinical trials against CC did not modify the clinical status, they occasionally show improvement of lymphocyte response against HPV. A recent immunotherapy trial using dendritic cells pulsed with HPV-18 E7 oncoprotein as adjuvant resulted in temporal remission and improved performance status in a patient with metastatic CC. New and different vaccine preventive trials against HPV are being put into practice and clinically tested. It is hoped that in the future it may be possible to eradicate cervical cancer. The success of immunotherapy anti-HPV clinical trials in CC patients will be determined at a future time. The scientific basis for the development of papillomavirus prophylactic and therapeutic vaccines against persistent infection and preinvasive-invasive associated cervical lesions along with the present status of immunopreventive and immunotherapy clinical trials against cervical cancer are commented on in this paper.