Clinical trial NCT05352308: Evaluation of a Narrative Communication Intervention to Increase Human Papillomavirus Vaccination Intentions and Uptake
Official title: The Evaluation of a Narrative Communication Intervention to Increase Human Papillomavirus Vaccination Intentions and Uptake in a Hispanic-Majority College Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papilloma Virus
Intention
Behavior
Lead sponsor: University of California, Merced
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change from baseline to immediately post-intervention in intentions
timeFrame: Baseline to 2 days post-baseline
measure: Change from immediately post-intervention to one-month post-intervention in intentions
timeFrame: 2 days post-baseline to one month post-baseline
Secondary outcomes:
measure: HPV Vaccine Uptake
timeFrame: one month post-baseline
measure: Change from baseline to immediately post-intervention in Knowledge of HPV and HPV Vaccine
timeFrame: baseline to 2 days post-baseline
measure: Change from baseline to immediately post-intervention in Effectiveness, Harms, Barriers, & Uncertainty of HPV Vaccine
timeFrame: baseline to 2 days post-baseline
measure: Change from baseline to immediately post-intervention in Perceived Severity & Susceptibility of the HPV Virus
timeFrame: baseline to 2 days post-baseline
measure: Change from baseline to immediately post-intervention in Illness Risk Representations
timeFrame: baseline to 2 days post-baseline
measure: Change from immediately post-intervention to one-month post-intervention in Illness Risk Representations
timeFrame: 2 days post-baseline to one month post-baseline
measure: Change from baseline to immediately post-intervention in Risk-Action Coherence
timeFrame: baseline to 2 days post-baseline
measure: Change from immediately post-intervention to one-month post-intervention in Risk-Action Coherence
timeFrame: 2 days post-baseline to one month post-baseline
measure: Narrative Engagement
timeFrame: 2 days post-baseline
measure: Realism
timeFrame: 2 days post-baseline
measure: Religious Commitment
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Merced
name: Linda Cameron, PhD
role: STUDY_DIRECTOR
References: