- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06098690
Culturally Tailored HPV Psychoeducational Multimedia Intervention
April 6, 2026 updated by: Eva Moya, 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
Completed
Conditions
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 (Actual)
63
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 Locations
-
-
Texas
-
El Paso, Texas, United States, 79968
- The University of Texas at El Paso, Border Biomedical Center
-
-
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
|
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
|
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 |
|---|---|---|
|
HPV Vaccination Status
Time Frame: Baseline (pre-assessment), 1 month post-intervention
|
HPV vaccine uptake (yes, no)
|
Baseline (pre-assessment), 1 month post-intervention
|
|
HPV Vaccine Intention Score
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV Vaccine Attitude Score
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
|
HPV vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, 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
|
|
HPV Knowledge Score
Time Frame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
|
HPV knowledge score measured using a 14-item 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
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 (Actual)
May 2, 2024
Primary Completion (Actual)
August 28, 2024
Study Completion (Actual)
August 28, 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)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
- Adult
- Female
- Male
- Health Disparities
- Social Determinants of Health
- Sexual and Reproductive Health
- Young Adult
- Behavioral Research
- Human Papillomavirus Vaccination
- Human Papillomavirus Cancer Screening
- HPV Cancer Prevention
- HPV Cancer Mitigation
- U.S.-Mexico Border Health
- Community Engaged Research
- Health Inequities
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
product manufactured in and exported from the U.S.
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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