Clinical trial NCT06367699: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV)- Clinical Trial
Official title: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Human Papilloma Virus
Cancer Prevention
Vaccination Promotion
Vaccination Attitudes
Vaccination Completion
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Northeastern University
First posted: 2024-04-16
Enrollment: 1750
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 parents/guardians 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 parent/guardian 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 parent/guardian 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 (parent/guardian 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 parent/guardian. 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 parent/guardian 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 parents/guardians 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.

Eligibility criteria: Inclusion Criteria:

For parent/guardian participants:

1. Speaks English fluently
2. Able to independently consent
3. Has adequate corrected vision to use the ECA-HPV system (based on their ability to go through the consent form)
4. Has adequate hearing to use the ECA-HPV system (based on their ability to hear the research staff member conducting the consent process)
5. Has a smartphone that is able to support the ECA-HPV app

For adolescent participants:

1. Is between the ages of 9-12 at the time of the index (first) well child visit
2. Has received either 1 or none of the HPV vaccine series
3. Speaks English fluently
4. Able to independently assent
5. Has adequate corrected vision to use the ECA-HPV system
6. Has adequate hearing to use the ECA-HPV system
7. Has a smartphone or has access to parent/guardian's smartphone (that is able to support the ECA-HPV app)
8. Has an upcoming well child visit at Boston Medical Center

Exclusion Criteria (for all participants):

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

Primary outcomes:
measure: HPV vaccination series completion comparing the control group to the intervention groups
timeFrame: 16 months
measure: HPV vaccination series completion comparing the intervention groups
timeFrame: 16 months
Secondary outcomes:
measure: HPV Knowledge
timeFrame: 16 months
measure: HPV Attitudes
timeFrame: 16 months
measure: General Vaccine Attitudes
timeFrame: 16 months
measure: ECA-HPV App Satisfaction
timeFrame: 16 months
measure: Clinic Notification Feature Satisfaction
timeFrame: 16 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Michael Paasche-Orlow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: