Clinical trial NCT06098690: Culturally Tailored HPV Psychoeducational Multimedia Intervention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Vaccine-Preventable Diseases
Intention
Adherence, Patient
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
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey.
timeFrame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
Secondary outcomes:
measure: Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey.
timeFrame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
measure: Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey.
timeFrame: Baseline (pre-assessment), immediately post-intervention (0 months), 1 month post-intervention
Other outcomes:
Locations:
city: El Paso
country: United States
facility: The University of Texas at El Paso, Border Biomedical Center
state: Texas
Study officials:
affiliation: The University of Texas at El Paso, Border Biomedical Research Center
name: Eva M Moya, PhD, LMSW
role: PRINCIPAL_INVESTIGATOR
References: