A Chatbot Intervention for Reducing HPV Vaccine Hesitancy

July 23, 2024 updated by: University of Maryland, College Park
The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online experiment will be conducted to test the effectiveness of the chatbot intervention with African American parents. Results of this project will inform future communication interventions for reducing vaccine hesitancy among African American parents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online survey-experiment will be conducted. In the survey-experiment, participants will first answer questions related to their attitudes toward childhood vaccines and see a brief CDC message about HPV vaccine. Then they will be directed to interact with a chatbot designed to deliver personalized HPV vaccine messages (tailored to the participant's personality) or a similar chatbot with non-personalized messages. There will also be a control condition where participants will see the brief CDC message about HPV vaccine but will not interact with any chatbot. All participants will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaoli Nan
  • Phone Number: 301-405-0640
  • Email: nan@umd.edu

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland, College Park (Online Survey-Experiment)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • Self-identify as Black or African American
  • Parents of children under 18 years old
  • Access to computer/laptop/mobile device and the Internet

Exclusion Criteria:

  • Under 18 years
  • Does not self-identify as Black or African American
  • Not a parent of at least a child under 18 years old
  • No access to computer/laptop/mobile device or the Internet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized Chatbot Condition
After reading a standard CDC HPV vaccine message, participants will interact with a chatbot designed to deliver personalized HPV vaccine messages (i.e., tailored to their personalities).
Behavioral: Personalized Chatbot Intervention
In this intervention, participants will first see a standard CDC HPV vaccine message. After that they will be invited to interact with a chatbot designed to deliver additional HPV vaccine messages, which are tailored to their personalities.
Experimental: Non-Personalized Chatbot Condition
After reading a standard CDC HPV vaccine message, participants will interact with a chatbot designed to deliver HPV vaccine messages, which are not tailored to their personalities.
Behavioral: Non-Personalized Chatbot Intervention
In this intervention, participants will first see a standard CDC HPV vaccine message. After that they will be invited to interact with a chatbot designed to deliver additional HPV vaccine messages, which are not tailored to their personalities.
Active Comparator: No Chatbot Control Condition
Participants will read a standard CDC HPV vaccine message without interacting with any chatbot that delivers additional messages.
Behavioral: No Chatbot Control
In this intervention, participants will see a standard CDC HPV vaccine message only and will not interact with any chatbot.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attitudes Toward HPV Vaccination
Time Frame: baseline posttest (test took approximately 5 minutes to complete)
Participants' attitudes toward HPV vaccination were measured by seven questions such as "The HPV vaccine is beneficial for adolescents." The responses were recorded on 1 (strongly disagree) to 5 (strongly agree) scales. Final score was the average of all 7 questions.
baseline posttest (test took approximately 5 minutes to complete)
Intentions Toward HPV Vaccination
Time Frame: baseline posttest (test took approximately 5 minutes to complete)
Participants' intentions toward vaccinating their children against HPV were measured by three questions such as "I am likely to get my child/children the HPV vaccine." Responses were indicated on 1 (strongly disagree) to 5 (strongly agree) scales. The final score was the average of the three questions.
baseline posttest (test took approximately 5 minutes to complete)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratings of the Chatbot
Time Frame: baseline posttest (test took approximately 5 minutes to complete)
Ratings of the Chatbot were measured by nine questions such as "How would you describe the HPV chatbot you just interacted with? - Engaging" on 1 (strongly disagree) to 5 (strongly agree) scales. The final score was the average of the nine questions.
baseline posttest (test took approximately 5 minutes to complete)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, College Park

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoli Nan, University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1960782-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share anonymized data on data repositories such as the Open Science Framework.

IPD Sharing Time Frame

After the study is published, for 5 years.

IPD Sharing Access Criteria

All information is open to the public.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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