NCT05120869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 22, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

October 6, 2021

Last Update Submit

September 2, 2025

Conditions

Keywords

Healthcare ProfessionalsHealth Personnel Knowledge, Attitudes, PracticesHealthcare Skills and TrainingHuman Papillomavirus VaccinationHuman Papillomavirus Cancer ScreeningHPV Cancer PreventionHPV Cancer MitigationSexual and Reproductive HealthU.S.-Mexico Border HealthBehavioral ResearchCommunity Engaged ResearchHealth DisparitiesHealth InequitiesSocial Determinants of HealthCoronavirus disease 2019 (COVID-19) Pandemic

Outcome Measures

Primary Outcomes (1)

  • Between-group changes in proportions from post-intervention scores of the Healthcare Provider (HCP) Practices scale on the Healthcare Personnel Survey

    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 Outcomes (2)

  • Between-group changes in proportions from post-intervention scores of the Human Papillomavirus (HPV) Vaccine Attitudes scale on the Healthcare Personnel Survey

    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

    immediately post-intervention (0 months), 3 months post-intervention, and 6 months post-intervention

Study Arms (2)

Treatment

EXPERIMENTAL

A tailored HPV education and professional skills intervention.

Behavioral: Tailored HPV Education and Professional Skills Intervention Group

Control

ACTIVE COMPARATOR

General/publicly available educational materials on HPV and communication skills.

Behavioral: General HPV Education and Communication Skills Control Group

Interventions

The provider education and professional skills intervention will involve audio and visual content and will be delivered in the English language.

Treatment

The general provider education intervention will involve audio and visual content and will be delivered in the English language.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Burrell College of Osteopathic Medicine

Las Cruces, New Mexico, 88001, United States

Location

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

El Paso, Texas, 79968, United States

Location

Related Publications (4)

  • Brabin L, Roberts SA, Farzaneh F, Kitchener HC. Future acceptance of adolescent human papillomavirus vaccination: a survey of parental attitudes. Vaccine. 2006 Apr 12;24(16):3087-94. doi: 10.1016/j.vaccine.2006.01.048. Epub 2006 Feb 9.

    PMID: 16500736BACKGROUND
  • McRee AL, Brewer NT, Reiter PL, Gottlieb SL, Smith JS. The Carolina HPV immunization attitudes and beliefs scale (CHIAS): scale development and associations with intentions to vaccinate. Sex Transm Dis. 2010 Apr;37(4):234-9. doi: 10.1097/OLQ.0b013e3181c37e15.

    PMID: 19940807BACKGROUND
  • Katz ML, Krieger JL, Roberto AJ. Human papillomavirus (HPV): college male's knowledge, perceived risk, sources of information, vaccine barriers and communication. J Mens Health. 2011 Oct 1;8(3):175-184. doi: 10.1016/j.jomh.2011.04.002.

    PMID: 21966351BACKGROUND
  • Martinez J, Cordero JI, Whitney M, LaRoche KL, Frietze G, Moya EM, Gosselink K. Web-Based Human Papillomavirus Education and Professional Skills Intervention for Health Care Providers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 3;14:e60790. doi: 10.2196/60790.

Related Links

MeSH Terms

Conditions

BehaviorCoitusCOVID-19

Condition Hierarchy (Ancestors)

Sexual BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eva M Moya, PhD, LMSW

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* 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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A parallel trial design will be used to examine the effectiveness of a tailored HPV education and professional skills intervention. Emerging and current healthcare providers will be randomly assigned to one of two conditions: 1) treatment condition in which they will receive a tailored Education and Professional Skills Intervention, and 2) control condition in which they will receive general, publicly available information about HPV and communication skills. Participants will then be followed over time and the responses will be compared between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2021

First Posted

November 15, 2021

Study Start

December 22, 2023

Primary Completion

December 2, 2024

Study Completion

December 2, 2024

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Approximately, starting 6 months-post scholarly publication of previously listed primary and secondary study outcome(s).
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.
More information

Locations