A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
Phase: NA
Conditions: Cervical Cancer, Anal Cancer, Penile Cancer
Sponsor: University of Maryland, College Park

Study Protocol 
 
Title of Project: A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination 
NCT #: NCT03856437 
02/10/2021 
 
1. Abstract:   
 
The overall goal of this project is to test the relative efficacy of gain- versus loss-framed messages in 
promoting adolescent HPV vaccination acceptance among African American parents. This project will 
provide useful insights into the design of psychologically targeted adolescent HPV vaccination 
messages for African Americans. 
 
2. Subject Selection: 
 
a. Recruitment: Participants will be recruited from online panels provided by survey companies.  
 
b. Eligibility Criteria:  Participants must meet the following criteria: 1) be at least 18 years old; 2) 
self-identify as African American; 3) be a custodial parent or caretaker of at least one child who 
has not initiated or completed the HPV vaccine series. 
 
c. Rationale: African American women are more likely to develop cervical cancer and die from 
cervical cancer, a disease that can be prevented from the HPV vaccine. Understanding effective 
methods of communicating to African American parents about the importance of HPV 
vaccination is therefore critical. 
 
d. Enrollment Numbers: We plan to enroll approximately 2,000 participants. 
 
e. Rationale for Enrollment Numbers: A large sample size ensures adequate statistical power to 
detect even small effect sizes. 
 
3. Procedures: 
 
Participants will complete a computer-assisted survey. In the survey participants will first 
answer questions related to their beliefs about HPV and the HPV vaccine, as well as other 
background information. Then they will be presented with a gain-framed, a loss-framed, or a 
non-framed HPV vaccination message. After message exposure, they will answer questions 
related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well 
as other message response measures. The survey will take approximately 20 minutes. 
Participants will be compensated by the survey companies in accordance to their policies.   
 
4. Risks: 
 
There are no known risks associated with this research. Some participants may be 
uncomfortable answering some questions. All participants have the option of not responding to 
questions they do not wish to answer. 
 
5. Benefits: 

Study Protocol 
 
Title of Project: A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination 
NCT #: NCT03856437 
02/10/2021 
 
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 questionnaires will not contain any 
questions that ask for information that could be used to identify the participants. The online 
survey will be anonymous. Only approved researchers will have access to the data collected. 
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 and 
allow the research team to thoroughly analyze the data for research purposes only. The 
research data will be destroyed afterwards (removed from computer hard disks).  
 
7. Consent Process: 
 
Before the participants begin the study, they will be asked to read a consent form containing 
information on the purpose of the study, the procedures involved, confidentiality, and potential risks 
and benefits. It will also state that participants can withdraw from the study at any time if they feel 
uncomfortable with the survey. Participants will have the choice to continue with the study or not after 
reading the consent form.  
 
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