Culturally Tailored HPV Psychoeducational Multimedia Intervention

NCT06098690 | Completed

• 2 other identifiers: 8321-22U54MD007592-26
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• HPV Vaccination Status

  HPV vaccine uptake (yes, no)

  Baseline (pre-assessment), 1 month post-intervention

• HPV Vaccine Intention Score

  HPV vaccine intention score measured 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 Outcomes (2)

• HPV Vaccine Attitude Score

  Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention

• HPV Knowledge Score

  Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention

Study Arms (2)

Treatment

EXPERIMENTAL

A tailored HPV psychoeducational multimedia intervention

Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention

Active Control

ACTIVE COMPARATOR

General/standard multimedia materials on HPV and HPV vaccine

Behavioral: General HPV Multimedia Psychoeducational Control Group

Interventions

Culturally Tailored Multimedia Psychoeducational HPV Intervention 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.

Treatment

General HPV Multimedia Psychoeducational Control Group 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.

Active Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas, El Paso: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The University of Texas at El Paso, Border Biomedical Center

El Paso, Texas, 79968, United States

Location

Related Links

• NIH RePORTER for 2U54MD007592-26 8321

MeSH Terms

Conditions

Behavior; Vaccine-Preventable Diseases; Patient Compliance; Coitus

Condition Hierarchy (Ancestors)

Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Sexual Behavior

Study Officials

• Eva M Moya, PhD, LMSW

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: May 2, 2024
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)