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Culturally Tailored HPV Psychoeducational Multimedia Intervention

Primary Purpose

Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Tailored Multimedia Psychoeducational HPV Intervention
General HPV Multimedia Psychoeducational Control Group
Sponsored by
University of Texas, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Knowledge, Attitudes, Practice focused on measuring 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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Texas at El Paso, Border Biomedical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Active Control

Arm Description

A tailored HPV psychoeducational multimedia intervention

General/standard multimedia materials on HPV and HPV vaccine

Outcomes

Primary Outcome Measures

HPV Vaccine Decision Stage
Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 2-item Vaccination Decision Stage (HPV vaccine status, HPV vaccine intention) scored on a likert scale from 1) Strongly disagree to (5) Strongly agree.
HPV Vaccine Series Completion Stage (Rate of Completion)
Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received.
Adherence to HPV Vaccine Schedule
Between-group changes in proportions from baseline scores on the Vaccine Series Completion Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received and receipt of second and third dose within manufacturer/vaccine label recommended dose schedule (or specified time period).

Secondary Outcome Measures

HPV Vaccine Attitudes
Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey. Assessed: 11-item HPV Vaccine Attitudes scale (perceived safety [Brabin et al., 2006], perceived harm [McRee et al., 2010], perceived effectiveness [Brabin et al., 2006]) scored on a likert scale from Strongly disagree (1) to Strongly agree (5).
HPV Knowledge
Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey. Assessed: 14-item HPV Knowledge scale (Katz, Krieger & Roberto, 2011) scored as True (1) or False (0) on a composite average and multiplying by 100 to obtain a percentage.

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
University of Texas, El Paso
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06098690
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas, El Paso
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 vaccination completion 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: Young and middle-aged adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccination completion rates when compared to young and middle-aged adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
A tailored HPV psychoeducational multimedia intervention
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
General/standard multimedia materials on HPV and HPV vaccine
Intervention Type
Behavioral
Intervention Name(s)
Culturally Tailored Multimedia Psychoeducational HPV Intervention
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.
Intervention Type
Behavioral
Intervention Name(s)
General HPV Multimedia Psychoeducational Control Group
Intervention 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.
Primary Outcome Measure Information:
Title
HPV Vaccine Decision Stage
Description
Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 2-item Vaccination Decision Stage (HPV vaccine status, HPV vaccine intention) scored on a likert scale from 1) Strongly disagree to (5) Strongly agree.
Time Frame
Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.
Title
HPV Vaccine Series Completion Stage (Rate of Completion)
Description
Between-group changes in proportions from baseline scores on the Vaccination Decision Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received.
Time Frame
Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.
Title
Adherence to HPV Vaccine Schedule
Description
Between-group changes in proportions from baseline scores on the Vaccine Series Completion Stage scale and post-intervention scores of the Community Intervention Survey. Assessed: 4-item Vaccine Series Completion Stage (HPV vaccine status, HPV vaccine uptake history) scored based on vaccine uptake or composite average (0) no vaccine uptake to (3) 3 doses received and receipt of second and third dose within manufacturer/vaccine label recommended dose schedule (or specified time period).
Time Frame
Baseline (pre-assessment), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.
Secondary Outcome Measure Information:
Title
HPV Vaccine Attitudes
Description
Between-group changes in proportions from baseline scores on the HPV Vaccine Attitudes scale and post-intervention scores of the Community Intervention Survey. Assessed: 11-item HPV Vaccine Attitudes scale (perceived safety [Brabin et al., 2006], perceived harm [McRee et al., 2010], perceived effectiveness [Brabin et al., 2006]) scored on a likert scale from Strongly disagree (1) to Strongly agree (5).
Time Frame
Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.
Title
HPV Knowledge
Description
Between-group changes in proportions from baseline scores on the HPV Knowledge scale and post-intervention scores of the Community Intervention Survey. Assessed: 14-item HPV Knowledge scale (Katz, Krieger & Roberto, 2011) scored as True (1) or False (0) on a composite average and multiplying by 100 to obtain a percentage.
Time Frame
Baseline (pre-assessment), immediately post-intervention (0 months), 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva M Moya, PhD, LMSW
Phone
(915) 747-8493
Email
emmoya@utep.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Demeo Brown, MSW
Phone
(915) 747-6313
Email
jayala8@utep.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Moya, PhD, LMSW
Organizational Affiliation
The University of Texas at El Paso, Border Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at El Paso, Border Biomedical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79968
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Border Biomedical Research Center
Phone
915-747-5536
Email
bbrc@utep.edu
First Name & Middle Initial & Last Name & Degree
UTEP Institutional Review Board
Phone
915-747-6590
Email
irb.orsp@utep.edu
First Name & Middle Initial & Last Name & Degree
Eva M Moya, PhD, LMSW
First Name & Middle Initial & Last Name & Degree
Margie M Padilla, PharmD
First Name & Middle Initial & Last Name & Degree
Gabriel A Frietze, PhD
First Name & Middle Initial & Last Name & Degree
Kristin Gosselink, PhD
First Name & Middle Initial & Last Name & Degree
Jacob Martinez, PhD, RN
First Name & Middle Initial & Last Name & Degree
Jacquelin Cordero, LMSW

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.
IPD Sharing Time Frame
Approximately, starting 6 months-post scholarly publication of previously listed primary and secondary study outcome(s).
IPD Sharing Access Criteria
Collected deidentified IPD and supporting information will be provided on a case by case basis following a formal request to the University of Texas at El Paso (UTEP) Institutional Review Board (IRB) and subsequent approval by the Principal Investigator.
IPD Sharing URL
http://www.utep.edu/orsp/human-subjects-research/index.html
Links:
URL
http://reporter.nih.gov/project-details/9828289
Description
NIH RePORTER for 2U54MD007592-26 8321

Learn more about this trial

Culturally Tailored HPV Psychoeducational Multimedia Intervention

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