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

NCT05352308 | Unknown

• 1 other identifier: UCM2021-142
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Papilloma Virus; Intention; Behavior

Outcome Measures

Primary Outcomes (2)

• Change from baseline to immediately post-intervention in intentions

  Intentions will be assessed with a previous measure to assess behavioral intentions (α = .92 in a sample of young adults; Moyer-Guse, Chung, \& Jain, 2011) which has been adapted for use to assess intentions to engage in several HPV-related behaviors (Landrau, 2020). The assessment asks participants, on a scale of 1 = definitely will not to 7 = definitely will, "What is the likelihood that you will": (1) "Get the HPV vaccine within the next 30 days" and (2) "Get the HPV vaccine within the next 12 months." Several other HPV-related behaviors are assessed by asking participants, "What is the likelihood that you will engage in the following behaviors over the next 6 months on a scale of 0 = definitely will not to 6 = definitely will." Sample statements include (1) "Discuss the HPV vaccine with a healthcare provider" and (2) "Search for more information about the HPV vaccine." Higher scores indicate higher intentions to engage in HPV-related behaviors.

  Baseline to 2 days post-baseline

• Change from immediately post-intervention to one-month post-intervention in intentions

  Intentions will be assessed with a previous measure to assess behavioral intentions (α = .92 in a sample of young adults; Moyer-Guse, Chung, \& Jain, 2011) which has been adapted for use to assess intentions to engage in several HPV-related behaviors (Landrau, 2020). The assessment asks participants, on a scale of 1 = definitely will not to 7 = definitely will, "What is the likelihood that you will": (1) "Get the HPV vaccine within the next 30 days" and (2) "Get the HPV vaccine within the next 12 months." Several other HPV-related behaviors are assessed by asking participants, "What is the likelihood that you will engage in the following behaviors over the next 6 months on a scale of 0 = definitely will not to 6 = definitely will." Sample statements include (1) "Discuss the HPV vaccine with a healthcare provider" and (2) "Search for more information about the HPV vaccine." Higher scores indicate higher intentions to engage in HPV-related behaviors.

  2 days post-baseline to one month post-baseline

Secondary Outcomes (11)

• HPV Vaccine Uptake

  one month post-baseline

• Change from baseline to immediately post-intervention in Knowledge of HPV and HPV Vaccine

  baseline to 2 days post-baseline

• Change from baseline to immediately post-intervention in Effectiveness, Harms, Barriers, & Uncertainty of HPV Vaccine

  baseline to 2 days post-baseline

• Change from baseline to immediately post-intervention in Perceived Severity & Susceptibility of the HPV Virus

  baseline to 2 days post-baseline

• Change from baseline to immediately post-intervention in Illness Risk Representations

  baseline to 2 days post-baseline

Study Arms (3)

Common Sense Model Guided Narrative Video Group

EXPERIMENTAL

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.

Behavioral: Common Sense Model Guided Narrative Video

Standard of Care Group

NO INTERVENTION

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.

Time & Attention Group

NO INTERVENTION

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

Interventions

Common Sense Model Guided Narrative Video BEHAVIORAL

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

Common Sense Model Guided Narrative Video Group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sara Fleszar: lead

MeSH Terms

Conditions

Behavior

Study Officials

• Linda Cameron, PhD

  University of California, Merced

  STUDY DIRECTOR

Central Study Contacts

Sara Fleszar-Pavlovic

CONTACT

8504456978; sfleszar@ucmerced.edu

Linda Cameron, PhD

CONTACT

lcameron@ucmerced.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: April 20, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04