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Behavioral Intervention
ECA-HPV App with Clinic Notification Function Enabled for Human Papillomavirus
N/A
Waitlist Available
Led By Michael Paasche-Orlow, MD, MPH
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
Study Summary
This trial aims to evaluate how well a program called ECA-HPV works in increasing HPV vaccination rates and satisfaction over a 16-month period. The study will also compare the effectiveness of clinic notification
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a digital application rather than medication, traditional side effects are not applicable. However, there may be privacy concerns or potential stress related to using the app.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HPV vaccination series completion comparing the control group to the intervention groups
HPV vaccination series completion comparing the intervention groups
Secondary outcome measures
Clinic Notification Feature Satisfaction
ECA-HPV App Satisfaction
General Vaccine Attitudes
+2 moreTrial Design
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.
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Who is running the clinical trial?
Boston Medical CenterOTHER
385 Previous Clinical Trials
871,820 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
253,987 Total Patients Enrolled
Northeastern UniversityOTHER
89 Previous Clinical Trials
59,576 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the principal goals that this medical study aims to achieve?
"The primary endpoint of this clinical investigation, to be assessed over a period spanning approximately 16 months, is the completion of the HPV vaccination series within the intervention cohorts. Additional aims consist of evaluating HPV attitudes among both parent/guardian and adolescent subjects in three surveys conducted at baseline (T0), after the initial well-child visit (T1), and following the subsequent well-child visit (T2). These surveys will be administered via REDCap. Comparative analysis between T0 outcomes and those at T1 and T2 will also extend to general vaccine perceptions among parent/guardian participants as well as assessing their knowledge regarding HPV across these time points"
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Are individuals older than 40 years of age eligible to participate in this study?
"Participants must be between 9 and 12 years old to qualify for enrollment in this clinical trial."
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Which individuals meet the criteria to be considered for inclusion in this research study?
"Individuals aged between 9 and 12 years with a confirmed human papillomavirus infection are eligible for enrollment in this research, which aims to recruit a total of 1750 participants."
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Is the enrollment for this medical study currently open and accepting participants?
"As per clinicaltrials.gov, this investigation is not presently seeking subjects. The trial was first listed on June 1st, 2024, with the most recent update made on April 11th, 2024. Although this specific study is no longer enrolling participants, there are currently 89 other trials actively recruiting individuals."
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