Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367699
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-11
Brief Title:
Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care ECA-HPV Clinical Trial
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
In the US universal Human Papillomavirus HPV vaccination has the potential to decrease overall burdens of certain cancers However HPV vaccination rates for US adolescents of all races ethnicities and income levels remain below national targets Embodied Conversational Agents ECAs are animated computer agents that simulate face-to-face conversation between a patient and a caregiver to provide a natural and intuitive computer interface that is accessible to patients of all levels of health and computer literacy In this project we produced smartphone ECAs for HPV vaccination to provide vaccine recommendations and motivational interviewing to parentsguardians and vaccine-eligible adolescents and facilitate communication with clinic staff
In this study we will be using the ECA-HPV system to administer interactive information to parents and adolescents in the form of a smartphone app We will obtain data from participants by asking subjects to fill out surveys on REDCap and electronically from use of the ECA system The parentguardian and adolescent participants will each complete 3 surveys over a 16-month period occurring at baseline after the first well child visit and after the second well child visit anticipated to be 1 year after their initial well child visit Additionally a randomly selected subset of adolescent and parentguardian participant dyads who were in an intervention group where adolescents also had the ECA-HPV adolescent app will be interviewed after their first well child visit about their experience Lastly for healthcare providers who have interacted with at least 5 study participants in any of the intervention groups they will be recruited to participate in qualitative interviews
For this RCT the participant dyads parentguardian and adolescent will be randomly assigned into one of five groups N 875 dyads The control group will receive usual standard care n 175 dyads The other four groups are intervention groups in which all will get the ECA-HPV app for the parentguardian Additionally these four groups will receive either 1 the complete ECA-HPV including the ECA-HPV adolescent app and the clinic notification feature on both the parentguardian and adolescent apps n 175 dyads 2 the ECA-HPV app and adolescent ECA-HPV app with the clinic communication function disabled n 175 dyads 3 the ECA-HPV app with clinic notification with no adolescent ECA-HPV app n 175 dyads or 4 the ECA-HPV app with no clinic communication feature and no adolescent ECA-HPV app n 175 dyads
For this study we will evaluate whether 1 adolescents who receive the ECA-HPV intervention will have a higher rate of HPV vaccine series completion 2 participating parentsguardians will have higher vaccine knowledge and greater intention to vaccinate and 3 vaccine series completion rates will be higher for those receiving the full ECA-HPV intervention compared to those who get ECA-HPV without the adolescent or clinic notification components
In this study we will be using the ECA-HPV system to administer interactive information to parents and adolescents in the form of a smartphone app We will obtain data from participants by asking subjects to fill out surveys on REDCap and electronically from use of the ECA system The parentguardian and adolescent participants will each complete 3 surveys over a 16-month period occurring at baseline after the first well child visit and after the second well child visit anticipated to be 1 year after their initial well child visit Additionally a randomly selected subset of adolescent and parentguardian participant dyads who were in an intervention group where adolescents also had the ECA-HPV adolescent app will be interviewed after their first well child visit about their experience Lastly for healthcare providers who have interacted with at least 5 study participants in any of the intervention groups they will be recruited to participate in qualitative interviews
For this RCT the participant dyads parentguardian and adolescent will be randomly assigned into one of five groups N 875 dyads The control group will receive usual standard care n 175 dyads The other four groups are intervention groups in which all will get the ECA-HPV app for the parentguardian Additionally these four groups will receive either 1 the complete ECA-HPV including the ECA-HPV adolescent app and the clinic notification feature on both the parentguardian and adolescent apps n 175 dyads 2 the ECA-HPV app and adolescent ECA-HPV app with the clinic communication function disabled n 175 dyads 3 the ECA-HPV app with clinic notification with no adolescent ECA-HPV app n 175 dyads or 4 the ECA-HPV app with no clinic communication feature and no adolescent ECA-HPV app n 175 dyads
For this study we will evaluate whether 1 adolescents who receive the ECA-HPV intervention will have a higher rate of HPV vaccine series completion 2 participating parentsguardians will have higher vaccine knowledge and greater intention to vaccinate and 3 vaccine series completion rates will be higher for those receiving the full ECA-HPV intervention compared to those who get ECA-HPV without the adolescent or clinic notification components
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None