Evaluation of a Narrative Communication Intervention to Increase Human Papillomavirus Vaccination Intentions and Uptake

NCT ID: NCT05352308

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-07-31

Brief Summary

The current study aims to evaluate a newly developed CSM narrative intervention in increasing HPV vaccination intentions and uptake in adults aged 18 to 26 years. The efficacy of the newly designed CSM-guided narrative video will be compared against a time and attention video and the standard of care print educational materials in increasing the intentions and uptake of the HPV vaccine in an adult Hispanic-majority college population. It is expected that participants receiving the CSM-guided narrative video will have greater HPV vaccine intentions compared with participants in the time and attention video and standard of care print education material groups. It is also hypothesized that participants receiving the CSM-guided narrative video will have greater HPV vaccine uptake at one month post-intervention compared with participants in the time and attention video and standard of care print education material groups.

Detailed Description

The current study aims to evaluate a newly developed CSM narrative intervention in increasing HPV vaccination intentions and uptake in adults aged 18 to 26 years. The efficacy of the newly designed CSM-guided narrative video will be compared against a time and attention video and the standard of care print educational materials in increasing the intentions and uptake of the HPV vaccine in an adult Hispanic-majority college population.

Main Hypotheses:

H1. Participants receiving the CSM-guided narrative video will have greater HPV vaccine intentions compared with participants in the time and attention video and standard of care print education material groups.

H2. Participants receiving the CSM-guided narrative video will have greater HPV vaccine uptake at one month post-intervention compared with participants in the time and attention video and standard of care print education material groups.

Secondary Hypotheses:

H3: For participants receiving the CSM-guided narrative video compared with participants in the time and attention video and standard of care print education material, it is expected that there will be increases in illness risk perceptions, risk-action coherence, knowledge of the HPV and HPV vaccine, perceived effectiveness of the HPV vaccine, perceived severity and susceptibility of HPV and decreases in perceived harms of the HPV vaccine, barriers to the HPV vaccine, and uncertainty of the HPV vaccine immediately post-intervention as well as one month post-intervention.

H4. It is expected that the relationship between intervention groups (i.e., CSM-guided narrative video, time and attention video, standard of care print material) and vaccine uptake will be moderated by three sets of moderators: (1) knowledge of HPV and the HPV vaccine, illness risk perceptions, risk-action coherence, narrative engagement, and realism, (2) perceived effectiveness of the HPV vaccine, perceived severity and susceptibility of the HPV virus, and perceived harms of the vaccine, barriers to receiving the vaccine, and uncertainty of the vaccine, and (3) vaccine intentions.

H5. It is expected that permissive sexual behavior will moderate the relationship between the intervention groups (i.e., CSM-guided narrative video, time and attention video, standard of care print material) and vaccine intentions and uptake, and knowledge of HPV and the vaccine. Further, it is expected that this relationship will be moderated by religious commitment.

H6. It is expected that there will be a moderating effect of story-telling cultures (Hispanic/Latinx and/or African American/Black compared to non-Hispanic white participants) on the relationship between the intervention groups (i.e., CSM-guided narrative video, time and attention video, standard of care print material) and vaccine intentions and uptake, narrative engagement, and realism.

Participants will be recruited via the University's SONA system for course credits. Students aged 18-26 years who have not received any doses of the HPV vaccine are eligible to participate. After completing the study screener, eligible participants will be directed to Qualtrics, a web-based survey platform. Participants will be asked to provide informed consent and complete a baseline survey. Once the baseline survey is complete, participants will be contacted 2 days post-baseline survey completion. At two days post-baseline participants will be randomized via Qualtrics' Randomizer into either the CSM-guided narrative video, to a time and attention video (i.e., CDC video on binge drinking), or the standard of care print educational materials (i.e., Centers for Disease Control and Prevention's Vaccine Information Statement). Participants will then be directed to a post-intervention survey via Qualtrics. Participants in all groups will be asked to be contacted by the research team one-month post-intervention to assess if they received the HPV vaccine. If they have not received the HPV vaccine, their intentions to receive the vaccine will be assessed as well as the longer-term effects of the groups on illness risk representations, risk-action link coherence, knowledge of HPV and HPV vaccine, and effectiveness, harms, barriers, and uncertainty of the HPV vaccine.

Conditions

Human Papilloma Virus; Intention; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Common Sense Model Guided Narrative Video Group

The narrative videos is guided by the CSM and designed to provide a comprehensive resource for college students. The narrative video addresses illness risk representations and information on HPV, the HPV vaccine, and HPV-related cancers. The format of the narrative video includes (1) a direct testimonial of a college woman (in her dorm room) telling a story to her roommates about what motivated her to get vaccinated, and (2) a conversation among the roommates where information about the HPV vaccine is discussed.

Group Type: EXPERIMENTAL

Common Sense Model Guided Narrative Video

Intervention Type: BEHAVIORAL

The narrative video will address illness risk representations and information on HPV, the HPV vaccine, and HPV-related cancers

Standard of Care Group

Participants in the standard of care group will receive the Centers for Disease Control and Prevention's Vaccine Information Statement (VIS; https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.pdf). The VIS contains information about HPV, the HPV vaccine, and the benefits and risks of the vaccine.

The VIS will be utilized because healthcare providers are required to distribute the VIS to patients before receiving each dose of the HPV vaccine, it is easy to understand, and it is publicly available information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Time & Attention Group

Participants in the time and attention video group will receive a Centers for Disease Control and Prevention video on binge drinking (https://youtu.be/I9hdkDTaQWU; 4:22 minutes). The video contains information on the health risks of binge drinking including unintended pregnancy, sexually transmitted diseases, injury, car accidents, violence, and HIV/AIDS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Common Sense Model Guided Narrative Video

The narrative video will address illness risk representations and information on HPV, the HPV vaccine, and HPV-related cancers

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Undergraduate students enrolled in the university's SONA system
• Aged 18-26 years
• Have not received any doses of the HPV vaccine
• Have working audio (e.g., headphones/speakers)

Exclusion Criteria

• Students who are not undergraduates
• Undergraduates not participating in the university's SONA system
• Aged <18 or >26 years
• Have received any dose/shot (1st, 2nd, or 3rd doses/shots) of the HPV vaccine
• Do not have working audio (e.g., headphones/speakers)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sara Fleszar

OTHER

Sponsor Role: lead

Responsible Party

Sara Fleszar

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linda Cameron, PhD

Role: STUDY_DIRECTOR

University of California, Merced

Central Contacts

Sara Fleszar-Pavlovic

Role: CONTACT

sfleszar@ucmerced.edu

8504456978

Linda Cameron, PhD

Role: CONTACT

lcameron@ucmerced.edu

Other Identifiers

UCM2021-142

Identifier Type: -

Identifier Source: org_study_id