Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV)- Clinical Trial

NCT06367699 | Terminated

• 1 other identifier: H-44821
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus

Keywords

Human Papilloma Virus; Cancer Prevention; Vaccination Promotion; Vaccination Attitudes; Vaccination Completion

Outcome Measures

Primary Outcomes (2)

• HPV vaccination series completion comparing the control group to the intervention groups

  HPV vaccination series completion for the control group will be compared to the collective rate for the intervention groups. A review of medical records at the T2 timepoint will be done for vaccination series completion.

  16 months

• HPV vaccination series completion comparing the intervention groups

  HPV vaccination series completion will be assessed between participants randomized to the full ECA-HPV versus people randomized to the ECA-HPV with no adolescent app function and no clinic notification function. A review of medical records at the T2 timepoint will be done for vaccination series completion.

  16 months

Secondary Outcomes (5)

• HPV Knowledge

  16 months

• HPV Attitudes

  16 months

• General Vaccine Attitudes

  16 months

• ECA-HPV App Satisfaction

  16 months

• Clinic Notification Feature Satisfaction

  16 months

Study Arms (5)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

ECA-HPV App with Clinic Notification and Adolescent Functions Disabled

EXPERIMENTAL

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.

Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions Disabled

ECA-HPV App with Clinic Notification Function Enabled

EXPERIMENTAL

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.

Behavioral: ECA-HPV App with Clinic Notification Function Enabled

ECA-HPV App with Adolescent Function Enabled

EXPERIMENTAL

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.

Behavioral: ECA-HPV App with Adolescent Function Enabled

ECA-HPV App with Clinic Notification and Adolescent Functions Enabled

EXPERIMENTAL

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.

Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled

Interventions

Usual Care BEHAVIORAL

Parent/guardian and adolescent participants will not receive the ECA-HPV system intervention. A survey will be given via REDCap to the parent/guardian and adolescent participants at baseline, after the first well child clinic visit, and after the second well child clinic visit to assess self-reported vaccination attitudes and behaviors. Adolescent participants will receive usual care.

Usual Care

ECA-HPV App with Clinic Notification and Adolescent Functions Disabled BEHAVIORAL

Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of \~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app. The clinic notification and adolescent functions of the complete ECA-HPV app are disabled. Adolescent participants will receive usual care.

ECA-HPV App with Clinic Notification and Adolescent Functions Disabled

ECA-HPV App with Clinic Notification Function Enabled BEHAVIORAL

Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of \~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app and the clinic notification feature. The clinic notification is enabled on the parent/guardian ECA-HPV app, however, the adolescent does not have access to the adolescent ECA-HPV app. Adolescent participants will receive usual care.

ECA-HPV App with Clinic Notification Function Enabled

ECA-HPV App with Adolescent Function Enabled BEHAVIORAL

Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of \~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction. The adolescent function is enabled, however, the clinic notification function is disabled. Thus, the ECA-HPV system app will have an adolescent-facing feature for adolescent participants to engage with the agent. Adolescent participants will receive usual care and will be able to engage with the adolescent version of the ECA-HPV app throughout the duration of the study.

ECA-HPV App with Adolescent Function Enabled

ECA-HPV App with Clinic Notification and Adolescent Functions Enabled BEHAVIORAL

Parent/guardian participants will interact with the complete ECA-HPV smartphone-based system over a period of \~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given to parent/guardian participants via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/ guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction and questions about the clinic notification feature. The complete ECA-HPV app includes the parent version and adolescent versions of the ECA-HPV app. Both versions have the clinic notification feature enabled. Adolescent participants will receive usual care and can engage with the adolescent version of the ECA-HPV app throughout the study.

ECA-HPV App with Clinic Notification and Adolescent Functions Enabled

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For parent/guardian participants:
• Speaks English fluently
• Able to independently consent
• Has adequate corrected vision to use the ECA-HPV system (based on their ability to go through the consent form)
• Has adequate hearing to use the ECA-HPV system (based on their ability to hear the research staff member conducting the consent process)
• Has a smartphone that is able to support the ECA-HPV app
• For adolescent participants:
• Is between the ages of 9-12 at the time of the index (first) well child visit
• Has received either 1 or none of the HPV vaccine series
• Speaks English fluently
• Able to independently assent
• Has adequate corrected vision to use the ECA-HPV system
• Has adequate hearing to use the ECA-HPV system
• Has a smartphone or has access to parent/guardian's smartphone (that is able to support the ECA-HPV app)
• Has an upcoming well child visit at Boston Medical Center

You may not qualify if:

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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Boston Medical Center: collaborator
• Northeastern University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Michael Paasche-Orlow, MD, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: November 13, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)