Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention

February 28, 2024 updated by: Eva Moya, University of Texas, El Paso

Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Healthcare Provider Intervention

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A sample of emerging [in training] and current [in practice] health professionals from the El Paso U.S.-Mexico Border Region will be recruited to participate in a human papillomavirus (HPV) educational and professional skills intervention. Hypothesis: improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among eligible individuals through a tailored multi-media intervention to strengthen providers' ability to discuss HPV and vaccination in an informed and culturally competent manner, and increase subsequent provider recommendations.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Eva M Moya, PhD, LMSW
  • Phone Number: 915-747-8493
  • Email: emmoya@utep.edu

Study Locations

  • United States
    • New Mexico
      • Las Cruces, New Mexico, United States, 88001
        • Recruiting
        • Burrell College of Osteopathic Medicine
        • Contact:
          • Burrell College Office of Research and Sponsored Programs
          • Phone Number: 575-674-2338
          • Email: research@bcomnm.org
        • Principal Investigator:
          • Kristin Gosselink, PhD
    • Texas
      • El Paso, Texas, United States, 79968
        • Recruiting
        • The University of Texas at El Paso, Border Biomedical Research Center
        • Principal Investigator:
          • Kristin Gosselink, PhD
        • Contact:
          • Border Biomedical Research Center
          • Phone Number: 915-747-5536
          • Email: bbrc@utep.edu
        • Contact:
          • UTEP Institutional Review Board
          • Phone Number: 915-747-6590
          • Email: irb.orsp@utep.edu
        • Principal Investigator:
          • Eva M Moya, PhD, LMSW
        • Sub-Investigator:
          • Margie M Padilla, PharmD
        • Sub-Investigator:
          • Gabriel A Frietze, PhD
        • Sub-Investigator:
          • Jacob Martinez, PhD, RN
        • Sub-Investigator:
          • Jacquelin Cordero, LMSW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Current (in practice) or emerging (in training - medical student, resident, or fellow) healthcare provider
  • Working/training or living in the El Paso U.S.-Mexico Border Region (i.e., El Paso County, TX-Southern New Mexico)
  • Have the authorization to recommend/prescribe/administer the HPV vaccine

Exclusion Criteria:

  • Unaffiliated with the El Paso U.S.-Mexico Border Region (i.e., El Paso County, TX-Southern New Mexico)
  • Participation in Phases I or II of the larger research project [cross-sectional phases]
  • Does not identify as a current or emerging healthcare provider
  • Declines or is unable to participate in the full intervention and follow-up time-points
  • Unable to complete participation and activities in the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
A tailored HPV education and professional skills intervention.
Behavioral: Tailored HPV Education and Professional Skills Intervention Group
The provider education and professional skills intervention will involve audio and visual content and will be delivered in the English language.
Active Comparator: Control
General/publicly available educational materials on HPV and communication skills.
Behavioral: General HPV Education and Communication Skills Control Group
The general provider education intervention will involve audio and visual content and will be delivered in the English language.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group changes in proportions from post-intervention scores of the Healthcare Provider (HCP) Practices scale on the Healthcare Personnel Survey
Time Frame: immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention
8-item HCP Practices scale (HCP vaccine recommendations, HCP screening recommendations, HCP communication practices) scored on a Likert scale from Never (1) to Always (5)
immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group changes in proportions from post-intervention scores of the Human Papillomavirus (HPV) Vaccine Attitudes scale on the Healthcare Personnel Survey
Time Frame: immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention
9-item HPV Vaccine Attitudes scale (perceived safety, perceived harm, perceived effectiveness) scored on a Likert scale from Strongly disagree (1) to Strongly agree (5)
immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention
Between-group changes in proportions from post-intervention scores on the Human Papillomavirus (HPV) Knowledge scale on the Healthcare Personnel Survey
Time Frame: immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention
14-item HPV Knowledge scale scored as True (1) or False (0)
immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas, El Paso

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Burrell College of Osteopathic Medicine

Investigators

  • Principal Investigator: Eva M Moya, PhD, LMSW, The University of Texas at El Paso, Border Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8321 (CTEP)
  • 2U54MD007592-26 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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