Culturally Tailored HPV Psychoeducational Multimedia Intervention

NCT ID: NCT06098690

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2026-01-31

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 vaccine uptake 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: 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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
* 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.

Study Groups

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Treatment

A tailored HPV psychoeducational multimedia intervention

Group Type EXPERIMENTAL

Culturally Tailored Multimedia Psychoeducational HPV Intervention

Intervention Type BEHAVIORAL

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 Control

General/standard multimedia materials on HPV and HPV vaccine

Group Type ACTIVE_COMPARATOR

General HPV Multimedia Psychoeducational Control Group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Texas, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Eva Moya

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva M Moya, PhD, LMSW

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at El Paso, Border Biomedical Research Center

Locations

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The University of Texas at El Paso, Border Biomedical Center

El Paso, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eva M Moya, PhD, LMSW

Role: CONTACT

(915) 747-8493

Jacquelin Cordero, LMSW

Role: CONTACT

(915) 747-6313

Facility Contacts

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UTEP Border Biomedical Research Center

Role: primary

915-747-5536

UTEP Institutional Review Board

Role: backup

915-747-6590

Related Links

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http://reporter.nih.gov/project-details/9828289

NIH RePORTER for 2U54MD007592-26 8321

Other Identifiers

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2U54MD007592-26

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8321-2

Identifier Type: -

Identifier Source: org_study_id

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