Culturally Tailored HPV Psychoeducational Multimedia Intervention

March 8, 2024 updated by: University of Texas, El Paso

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

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 vaccine uptake rates.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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: Vaccine-eligible adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccine uptake rates when compared to vaccine-eligible adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eva M Moya, PhD, LMSW
  • Phone Number: (915) 747-8493
  • Email: emmoya@utep.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79968
        • The University of Texas at El Paso, Border Biomedical Center
        • Contact:
          • UTEP Institutional Review Board
          • Phone Number: 915-747-6590
          • Email: irb.orsp@utep.edu
        • Principal Investigator:
          • Eva M Moya, PhD, LMSW
        • Sub-Investigator:
          • Margie M Padilla, PharmD
        • Sub-Investigator:
          • Gabriel A Frietze, PhD
        • Sub-Investigator:
          • Kristin Gosselink, PhD
        • Sub-Investigator:
          • Jacob Martinez, PhD, RN
        • Sub-Investigator:
          • Jacquelin Cordero, LMSW
        • Contact:
          • UTEP Border Biomedical Research Center
          • Phone Number: 915-747-5536
          • Email: bbrc@utep.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey.
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
3-item Vaccination Decision Stage scale (HPV vaccine uptake [yes, no], HPV vaccine intention [scored on a likert scale from 1) Strongly disagree to (5) Strongly agree]).
Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey.
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
11-item HPV Vaccine Attitudes scale (perceived safety, perceived harm, perceived effectiveness) scored on a Likert scale from Strongly disagree (1) to Strongly agree (5).
Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey.
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
14-item HPV Knowledge scale scored as True (1) or False (0) on a composite average and multiplied by 100 to obtain a percentage.
Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas, El Paso

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Eva M Moya, PhD, LMSW, The University of Texas at El Paso, Border Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8321-2
  • 2U54MD007592-26 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

IPD Sharing Time Frame

Approximately, starting 6 months-post scholarly publication of previously listed primary and secondary study outcome(s).

IPD Sharing Access Criteria

Collected deidentified IPD and supporting information will be provided on a case by case basis following a formal request to the University of Texas at El Paso (UTEP) Institutional Review Board (IRB) and subsequent approval by the Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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