TeleHealth Model to Address Vaccine Hesitancy & Increase Vaccine Completion Among Communities in Southeastern Louisiana

Vaccine Hesitancy Clinical Trial

Official title: Using a Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana

Status Recruiting

Clinical Trial Summary

This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.

Clinical Trial Description

Individuals will be recruited using a community-based participatory research model to identify 525 patients to enter into an 24-30 month clinical pharmacist run, vaccine and health and wellness program delivered via Xavier's clinical pharmacy faculty trained in telehealth medicine using an individually randomized group treatment trial approach based upon industry of recruitment. Our recruitment will target enrollment of: 65% African-Americans, 10% Hispanic and 20% rural, with overlapping categories as necessary. Participants will be recruited from target high risk industries for COVID-19 infection: hospitality and food industry, plant workers, nurse's aides, teacher's aides and the beauty industries. Participants will complete a minimum of three individual visits and group informational visits. Both arms of the study will receive health and wellness visits. Only the vaccine intervention arm will receive the vaccine and counseling. Changes in vaccine hesitancy and monitoring for vaccine completion will occur by the clinical pharmacist via patient interviews and Links© access. The primary outcome will be completed COVID-19 vaccination series (primary series + applicable boosters). The secondary outcome will be completed influenza vaccine.

Impact: The implications of this proposed project are to understand health related beliefs and behaviors related to vaccination and vaccine hesitancy in the context of a general health and wellness model. This intervention approach aims to decrease vaccine disparities among vulnerable individuals. It will provide data to develop strategies to improve vaccination, especially COVID-19 vaccination, in vulnerable communities using pharmacy students and pharmacists. This grant will facilitate training early stage investigators and diversify the health research workforce as the researchers are underrepresented minorities and women. ;

Related Conditions & MeSH terms

• Vaccine Hesitancy

• NCT number: NCT05676970
• Study type: Interventional
• Source: Xavier University of Louisiana.
• Contact: Sara Al-Dahir, PharmD, PhD
• Phone: 504525766
• Email: saaldah@xula.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: December 30, 2028