Cervical CancerNCT05959564
A Chatbot Intervention for Reducing HPV Vaccine Hesitancy
A study testing Personalized Chatbot Intervention and Non-Personalized Chatbot Intervention in people with Cervical Cancer and Anal Cancer, run by University of Maryland, College Park at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Anal Cancer, Penile Cancer
- What is being tested?
- Personalized Chatbot Intervention and Non-Personalized Chatbot Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, College Park (Online Survey-Experiment)
College Park, Maryland, 20742
About this study
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.
Read the 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.
- Conditions
- Cervical Cancer, Anal Cancer, Penile Cancer
- Being tested
- Personalized Chatbot Intervention, Non-Personalized Chatbot Intervention, No Chatbot Control
- Medical subject headings
- Uterine Cervical Neoplasms, Anus Neoplasms, Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Chatbot InterventionBehavioural
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.
Non-Personalized Chatbot InterventionBehavioural
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.
No Chatbot ControlBehavioural
In this intervention, participants will see a standard CDC HPV vaccine message only and will not interact with any chatbot.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Chatbot Condition | Experimental | 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). Receives: Behavioral: Personalized Chatbot Intervention |
| Non-Personalized Chatbot Condition | Experimental | 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. Receives: Behavioral: Non-Personalized Chatbot Intervention |
| No Chatbot Control Condition | Active comparator | Participants will read a standard CDC HPV vaccine message without interacting with any chatbot that delivers additional messages. Receives: Behavioral: No Chatbot Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes Toward HPV Vaccination
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.
Measured: baseline posttest (test took approximately 5 minutes to complete)
Intentions Toward HPV Vaccination
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.
Measured: baseline posttest (test took approximately 5 minutes to complete)
Secondary outcomes (1)
Ratings of the Chatbot
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.
Measured: baseline posttest (test took approximately 5 minutes to complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start26 Jul 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Nan, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959564
- Sponsor's protocol ID
- 1960782-1
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share anonymized data on data repositories such as the Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chatbot Intervention for Reducing HPV Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT05959564
- Acronym / sponsor ID
- 1960782-1
- Conditions
- Cervical Cancer, Anal Cancer, Penile Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Chatbot Condition | Experimental | Behavioral: Personalized Chatbot InterventionAfter 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). |
| Non-Personalized Chatbot Condition | Experimental | Behavioral: Non-Personalized Chatbot InterventionAfter 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. |
| No Chatbot Control Condition | Active comparator | Behavioral: No Chatbot ControlParticipants will read a standard CDC HPV vaccine message without interacting with any chatbot that delivers additional messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Chatbot InterventionIn 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. | Behavioural | Personalized Chatbot Condition |
| Non-Personalized Chatbot InterventionIn 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. | Behavioural | Non-Personalized Chatbot Condition |
| No Chatbot ControlIn this intervention, participants will see a standard CDC HPV vaccine message only and will not interact with any chatbot. | Behavioural | No Chatbot Control Condition |
Primary outcome
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.
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.
1 secondary outcome
Ratings of the Chatbot
Time frame: baseline posttest (test took approximately 5 minutes to complete)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will share anonymized data on data repositories such as the Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoli Nan principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Chatbot Intervention and Non-Personalized Chatbot Intervention in people with Cervical Cancer and Anal Cancer, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes Toward HPV Vaccination (time frame: baseline posttest (test took approximately 5 minutes to complete)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.