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Culturally Tailored HPV Psychoeducational Multimedia Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06098690
Recruitment Status : Not yet recruiting
First Posted : October 24, 2023
Last Update Posted : May 13, 2024
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Texas, El Paso

Study Description
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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 vaccine uptake 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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.
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
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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]).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06098690


Contacts
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Contact: Eva M Moya, PhD, LMSW (915) 747-8493 emmoya@utep.edu
Contact: Jacquelin Cordero, LMSW (915) 747-6313 jcordero5@utep.edu

Locations
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United States, Texas
The University of Texas at El Paso, Border Biomedical Center
El Paso, Texas, United States, 79968
Contact: UTEP Border Biomedical Research Center    915-747-5536    bbrc@utep.edu   
Contact: UTEP Institutional Review Board    915-747-6590    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         
Sponsors and Collaborators
University of Texas, El Paso
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Eva M Moya, PhD, LMSW The University of Texas at El Paso, Border Biomedical Research Center
More Information
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Additional Information:

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Responsible Party: University of Texas, El Paso
ClinicalTrials.gov Identifier: NCT06098690    
Other Study ID Numbers: 8321-2
2U54MD007592-26 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Approximately, starting 6 months-post scholarly publication of previously listed primary and secondary study outcome(s).
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.
URL: http://www.utep.edu/orsp/human-subjects-research/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas, El Paso:
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
Additional relevant MeSH terms:
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Vaccine-Preventable Diseases
Infections