Culturally Tailored HPV Psychoeducational Multimedia Intervention

Health Knowledge, Attitudes, Practice Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06098690
• Other study ID #: 8321-2
• Secondary ID: 2U54MD007592-26
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University of Texas, El Paso
• Contact: Eva M Moya, PhD, LMSW
• Phone: (915) 747-8493
• Email: emmoya[@]utep.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Patient
• Health Knowledge, Attitudes, Practice
• Intention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas at El Paso, Border Biomedical Center	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas, El Paso	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey.	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]).	Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
Secondary	Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey.	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).	Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
Secondary	Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey.	14-item HPV Knowledge 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

External Links

•   NIH RePORTER for 2U54MD007592-26 8321