A Chatbot Intervention for Reducing HPV Vaccine Hesitancy
Phase: NA
Conditions: Cervical Cancer, Anal Cancer, Penile Cancer
Sponsor: University of Maryland, College Park

Study Protocol 
 
Title of Project: A Chatbot Intervention for Reducing HPV Vaccine Hesitancy 
NCT #: NCT05959564 
November 16, 2022 
 
 
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Revised: 6/30/2017 
 
 
INITIAL APPLICATION PART 2 
 
1. Abstract:   
 
The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV 
vaccine hesitancy among African American parents. This project has two phases. In 
phase I, in-depth interviews will be conducted with African American parents to evaluate 
the feasibility and acceptability of the chatbot intervention. In phase II, 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.  
 
2. Subject Selection: 
 
a. Recruitment: In phase I, we will recruit participants from local pediatric offices. We will 
recruit by distributing flyers in the offices. We will obtain permission from the practices to 
recruit at their offices. A copy of the flyer is attached to this application (we will submit an 
addendum if additional changes need to be made to the flyer before distribution). In 
phase II, participants will be recruited from online survey panels (e.g., Prolific, YouGov, 
Lucid, etc.). Eligible participants will be invited via email to participate in the study. There 
will also be screening questions at the beginning of the survey to screen participants to 
ensure they meet the eligible criteria.  
 
b. Eligibility Criteria:  Participants must be 18 years or older, self-identify as African 
American, are custodial parents or caretakers of a child under the age of 18.  
 
c. Rationale: The burden of HPV-associated diseases (e.g., cervical cancer) is 
disproportionately higher among African Americans compared to other racial groups. 
Understanding effective methods of communicating to African American parents about 
the importance of HPV vaccination is therefore critical. 
 
d. Enrollment Numbers: For phase I, we aim to recruit up to 30 participants. For phase II, 
we aim to recruit up to 600 participants.  
 
e. Rationale for Enrollment Numbers: The enrollment numbers ensure we have 
adequate statistical power to detect small effects of the intervention. 
 
3. Procedures: 
 
For phase I, we will conduct in-depth interviews with up to 30 African American 
parents recruited from local pediatric offices. To facilitate participation, the 
interviews will be conducted online via Zoom. During the interviews, participants 
will be asked to interact with a chatbot designed to answer questions about HPV 
vaccines. Their opinions about the chatbot and suggestions for improvement will 
be solicited. Each interview session will last approximately 45 minutes. Only 
anonymized transcription (using Zoom’s transcript function) of the interview will 

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be saved for later analysis. Interviews will not be audio- or video-taped. Each 
participant will receive a $50 store gift card. The cash incentive is needed to 
encourage participation in the study.  
 
In phase II, participants will complete an online survey. In the survey, participants 
will first answer questions related to their attitudes toward childhood vaccines. 
Then they will be directed to interact with a chatbot designed to deliver 
personalized HPV vaccine messages (tailed to the participant’s personality) or a 
similar chatbot with non-personalized messages. There will also be a control 
condition where participants receive no HPV vaccine messages. After interacting 
with the chatbot, participants will answer questions related to their attitudes 
toward HPV vaccination, intentions to vaccinate their children, as well as other 
message response measures. Those in the control will answer the same 
questions without interacting with a chatbot. The survey will take approximately 
10 minutes to complete. Participants who complete the survey will be 
compensated with a small amount of cash paid through the online survey 
platform ($1-$2). 
 
4. Risks: 
 
There are no known risks associated with this research. Participants may opt to exit the 
interview or survey if they are not comfortable answering any of the questions.  
 
5. Benefits: 
 
There are no direct benefits to participants. This research will result in an improved 
understanding of the design of effective educational materials about HPV vaccination. 
 
6. Confidentiality: 
 
Responses of the participants will be confidential. The transcriptions from the interviews 
will have no identifying information. The transcriptions will not be linked in any way to 
personally identifiable information. The questionnaires will not contain any questions that 
ask for information that could be used to identify the participants. Only approved 
researchers will have access to the data collected. Hard copy materials will be stored in 
a locked office. Data collected will be stored in a password-protected computer located 
in a room with limited access. All research data collected from this study will be stored 
for 10 years after the study allow the research team to thoroughly analyze the data for 
research purposes only. The research data will be removed from computer hard disks 
afterwards. 
 
7. Consent Process: 
 
Because this study involves online interviews and an online survey, we request a 
consent waiver because our research meets the following criteria: (1) this research 
involves no more than minimal risk to the subjects (no personally identifiable information 
is collected); (2) the waiver or alteration will not adversely affect the rights and welfare of 
the subjects (participants can stop their participation at any time during the study). The 
online consent form (see attached) is identical to a written consent form; (3) the research 

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could not practicably be carried out without the waiver or alteration (written signatures 
cannot be collected online). Participants will indicate consent by clicking a radio button. 
Online consent will be obtained prior to the study. Participants will be permitted to 
print/save a copy of the consent form for their records; and (4) the subjects will be 
provided with additional pertinent information after participation through the debriefing 
process (see attached). 
 
Participants who agree to participate will indicate consent by clicking a radio button in an 
online questionnaire (“I agree to participate”) before the start of the study (for both the 
online interview and the onine survey). No name will be required. Because the interviews 
are one-on-one, investigators will know whether or not a participant agrees to participate 
by examining the instantly recorded responses in the online questionnaire. There is no 
deception involved in either study. 
 
The title of the IRB application (Chatbot and Vaccine Acceptance) is different from the 
title on the consent forms (HPV Vaccine Messaging Study). We want to keep the title on 
the consent forms general because some of the participants will not interact with a 
chatbot. 
 
8. Conflict of Interest: 
 
 
There is no conflict of interest. 
 
9. HIPAA Compliance: 
 
N/A 
 
10. Research Outside of the United States: 
 
N/A 
 
11. Research Involving Prisoners: 
 
N/A 
 
12. SUPPORTING DOCUMENTS 
 
Your Initial Application must include a completed Initial Application Part 1 (On-Line 
Document), the information required in items 1-11 above, and all relevant supporting 
documents including: consent forms, letters sent to recruit participants, questionnaires 
completed by participants, and any other material that will be presented, viewed or read 
to human subject participants. 
 
 
The consent forms in your approved IRBNet PACKAGE must be used.  When 
creating or editing your consent form, please provide the most recent IRBNet 
package number at the bottom, right corner of the consent form.  This ensures 
you are using the most “up-to-date” version of the form.   
 

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To find your IRBNet package number, go to the MY PROJECTS tab and click on 
the title of your project. In the PROJECT OVERVIEW page, your IRBNet package 
number will be listed at the top, next to your project title.