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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
First received
Last updated
Start date June 2024
Est. completion date August 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
Health authority
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 August 2024
Est. primary completion date August 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.

Study Design


Related Conditions & MeSH terms


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
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