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

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

Interventions

BEHAVIORAL

Usual Care

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.

BEHAVIORAL

ECA-HPV App with Clinic Notification and Adolescent Functions Disabled

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.

BEHAVIORAL

ECA-HPV App with Clinic Notification Function Enabled

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.

BEHAVIORAL

ECA-HPV App with Adolescent Function Enabled

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.

BEHAVIORAL

ECA-HPV App with Clinic Notification and Adolescent Functions Enabled

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.

Sponsors & Collaborators

• Boston Medical Center

  collaborator OTHER

• Northeastern University

  collaborator OTHER

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Michael Paasche-Orlow, MD, MPH · Tufts Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-13

Primary Completion

2025-04-01

Completion

2025-04-01

Countries

• United States

Study Locations