Culturally Tailored HPV Psychoeducational Multimedia Intervention

Sponsor

University of Texas, El Paso (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06098690

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

44.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Health Knowledge, Attitudes, Practice Vaccine-Preventable Diseases Intention Adherence, Patient	Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention Behavioral: General HPV Multimedia Psychoeducational Control Group	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

Participants [blinding]: participants will be randomly assigned to treatment and control groups, they will not be made aware of other participant's receipt of treatment or control materials. Participants will be asked not to discuss this project outside of the intervention; delivery of the intervention or other educational materials will be virtual, limiting the ability of participants to interact with one another during the study. Outcome assessor [blinding]: to reduce bias in the implementation and assessment of the clinical trial, participant information and pre-post survey responses will be maintained separately from the assignment and delivery of the intervention.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A tailored HPV psychoeducational multimedia intervention	Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention 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.
Active Comparator: Active Control General/standard multimedia materials on HPV and HPV vaccine	Behavioral: General HPV Multimedia Psychoeducational Control Group 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.

Arm

Intervention/Treatment

Experimental: Treatment

A tailored HPV psychoeducational multimedia intervention

Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention

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.

Active Comparator: Active Control

General/standard multimedia materials on HPV and HPV vaccine

Behavioral: General HPV Multimedia Psychoeducational Control Group

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.

Outcome Measures

Primary Outcome Measures

HPV Vaccine Decision Stage [Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.]
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.
HPV Vaccine Series Completion Stage (Rate of Completion) [Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.]
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.
Adherence to HPV Vaccine Schedule [Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.]
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).

Secondary Outcome Measures

HPV Vaccine Attitudes [Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.]
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).
HPV Knowledge [Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.