Trial Title:
Culturally Tailored HPV Psychoeducational Multimedia Intervention
NCT ID:
NCT06098690
Condition:
Health Knowledge, Attitudes, Practice
Vaccine-Preventable Diseases
Intention
Adherence, Patient
Conditions: Official terms:
Vaccine-Preventable Diseases
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
- 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.
Intervention:
Intervention type:
Behavioral
Intervention name:
Culturally Tailored Multimedia Psychoeducational HPV Intervention
Description:
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.
Arm group label:
Treatment
Intervention type:
Behavioral
Intervention name:
General HPV Multimedia Psychoeducational Control Group
Description:
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.
Arm group label:
Active Control
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The University of Texas at El Paso, Border Biomedical Center
Address:
City:
El Paso
Zip:
79968
Country:
United States
Status:
Recruiting
Contact:
Last name:
UTEP Border Biomedical Research Center
Phone:
915-747-5536
Email:
bbrc@utep.edu
Contact backup:
Last name:
UTEP Institutional Review Board
Phone:
915-747-6590
Email:
irb.orsp@utep.edu
Investigator:
Last name:
Eva M Moya, PhD, LMSW
Email:
Principal Investigator
Investigator:
Last name:
Margie M Padilla, PharmD
Email:
Sub-Investigator
Investigator:
Last name:
Gabriel A Frietze, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kristin Gosselink, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jacob Martinez, PhD, RN
Email:
Sub-Investigator
Investigator:
Last name:
Jacquelin Cordero, LMSW
Email:
Sub-Investigator
Start date:
May 2, 2024
Completion date:
August 2024
Lead sponsor:
Agency:
University of Texas, El Paso
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Source:
University of Texas, El Paso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098690
http://reporter.nih.gov/project-details/9828289
