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Completed

NCT Number: NCT06098690

Culturally Tailored HPV Psychoeducational Multimedia 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at El Paso, Border Biomedical Center

El Paso, Texas, 79968, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey

    Time frame: 1-month post-intervention

    Human Papillomavirus (HPV) vaccine uptake was assessed using the self-reported question, "Since completing the initial survey, I have been vaccinated against HPV," which measured whether participants received the HPV vaccine after survey completion. The outcome was treated as a binary variable (Yes/No), with higher proportions indicating greater HPV vaccine uptake following the intervention.

  2. Changes in Human Papillomavirus (HPV) Vaccination Intention Score

    Time frame: baseline to 0 month post intervention (right after the survey)

    Human Papillomavirus (HPV) vaccination intention was assessed using a self-reported Likert-scale item measuring participants' intention to receive the HPV vaccine. Responses were recorded on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with higher scores indicating greater intention to receive HPV vaccination. Changes in HPV vaccination intention scores from baseline to follow-up were compared between intervention and control groups.

Secondary outcomes

  1. Human Papillomavirus (HPV) Vaccine Attitude Score

    Time frame: Baseline

    Human Papillomavirus (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).

    A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.

  2. Human Papillomavirus (HPV) Vaccine Attitude Score

    Time frame: 0 month post intervention

    Human Papillomavirus (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).

    A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.

  3. Human Papillomavirus (HPV) Vaccine Attitude Score

    Time frame: 1 month post intervention

    Human Papillomavirus (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).

    A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.

  4. Human Papillomavirus (HPV) Knowledge Score

    Time frame: Baseline (pre-assessment)

    The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.

    A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.

  5. Human Papillomavirus (HPV) Knowledge Score

    Time frame: 0 month post intervention

    The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.

    A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.

  6. Human Papillomavirus (HPV) Knowledge Score

    Time frame: 1 month post intervention

    The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.

    A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.

Sponsors and collaborators

Lead sponsor

University of Texas, El Paso

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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