Culturally Tailored HPV Psychoeducational Multimedia Intervention

Study Overview
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Brief Summary
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Community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region will be recruited to compare psychoeducational multimedia interventions focused on the human papillomavirus (HPV). Our hypothesis is that adults who view culturally tailored multimedia stories encouraging HPV vaccination will report higher vaccination completion rates.

Detailed Description
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A sample of vaccine-naive (unvaccinated or under-vaccinated) adult community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region, will be recruited to participate in a human papillomavirus (HPV) multi-media intervention. Hypothesis: Young and middle-aged adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccination completion rates when compared to young and middle-aged adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.

Official Title
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Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Community Intervention

Conditions
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Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention, Adherence, Patient

Intervention / Treatment
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* Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention
* Behavioral: General HPV Multimedia Psychoeducational Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages 18 and 45 years old Adults who have not completed the HPV vaccine series (unvaccinated or under-vaccinated) Adults currently living or working in El Paso County, Texas Exclusion Criteria: Adults who participated in Phases I or II of the larger research project [cross-sectional phases] Adults younger than 18 years of age Adults older than 45 years of age Adults that do not reside, plan to live or work in El Paso County, Texas, within the next 12 months after the start of the intervention Adults who are unable to participate in the full study intervention and follow-up time-points Adults who cannot complete study participation and activities in either the English or Spanish languages.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel trial design will be used to examine the effectiveness of the Culturally Tailored HPV Psychoeducational Multimedia Community Intervention. Community members who are HPV vaccine naïve or under-vaccinated (given vaccine recommendations) will be randomly assigned to one of two conditions: 1) experimental condition in which they receive the tailored multimedia intervention, and 2) active control condition in which they receive general/standard materials.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>A tailored HPV psychoeducational multimedia intervention | Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention<br>* The culturally tailored multimedia psychoeducational intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.<br>|
| Active Comparator: Active Control<br>General/standard multimedia materials on HPV and HPV vaccine | Behavioral: General HPV Multimedia Psychoeducational Control Group<br>* The general/publicly available multimedia intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV Vaccine Decision Stage | Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 2-item Vaccination Decision Stage (HPV vaccine status, HPV vaccine intention) scored on a likert scale from 1) Strongly disagree to (5) Strongly agree. | Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention. | 
| HPV Vaccine Series Completion Stage (Rate of Completion) | Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received. | Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention. | 
| Adherence to HPV Vaccine Schedule | Between-group changes in proportions from baseline scores on the Vaccine Series Completion Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received and receipt of second and third dose within manufacturer/vaccine label recommended dose schedule (or specified time period). | Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV Vaccine Attitudes | Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey. Assessed: 11-item HPV Vaccine Attitudes scale (perceived safety [Brabin et al., 2006], perceived harm [McRee et al., 2010], perceived effectiveness [Brabin et al., 2006]) scored on a likert scale from Strongly disagree (1) to Strongly agree (5). | Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention. | 
| HPV Knowledge | Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey. Assessed: 14-item HPV Knowledge scale (Katz, Krieger & Roberto, 2011) scored as True (1) or False (0) on a composite average and multiplying by 100 to obtain a percentage. | Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus Vaccination, Human Papillomavirus Cancer Screening, HPV Cancer Prevention, HPV Cancer Mitigation, Sexual and Reproductive Health, U.S.-Mexico Border Health, Behavioral Research, Community Engaged Research, Health Disparities, Health Inequities, Social Determinants of Health, Male, Female, Adult, Young Adult