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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05120869
Other study ID # 8321
Secondary ID 2U54MD007592-26
Status Recruiting
Phase N/A
First received
Last updated
Start date December 19, 2023
Est. completion date December 2024

Study information

Verified date May 2024
Source University of Texas, El Paso
Contact Kristin Gosselink, PhD
Phone 575-674-2335
Email kgosselink@burrell.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States The University of Texas at El Paso, Border Biomedical Research Center El Paso Texas
United States Burrell College of Osteopathic Medicine Las Cruces New Mexico

Sponsors (3)

Lead Sponsor Collaborator
University of Texas, El Paso Burrell College of Osteopathic Medicine, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Between-group changes in proportions from post-intervention scores of the Human Papillomavirus (HPV) Vaccine Attitudes scale on the Healthcare Personnel Survey 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
Secondary Between-group changes in proportions from post-intervention scores on the Human Papillomavirus (HPV) Knowledge scale on the Healthcare Personnel Survey 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
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