COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana

COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana

This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care.

Study Overview

• Status: Completed
• Conditions: Covid19; Vaccine Hesitancy; Vaccine Refusal
• Intervention / Treatment: Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing

Detailed Description

This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics. The proposal will introduce a rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel and includes monitoring for COVID-19 vaccine completion among enrolled patients. Investigators anticipate an increase in COVID-19 vaccine completion rates for those who participate in the rapid vaccination education model.

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Al-Dahir, PharmD; Phone Number: 5045205766; Email: saaldah@xula.edu
• Study Contact Backup: Name: Mohamed Belkhouche, PharmD; Phone Number: 5049130315; Email: mbelkhou@xula.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70125
      • Xavier University of Louisiana
      • Contact: Brittany Singleton, PharmD; Phone Number: 5045207308; Email: bsingle2@xula.edu
      • Contact: Sara Al-Dahir, PharmD; Phone Number: 504-520-5766; Email: saaldah@xula.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in English, Spanish or Arabic. Also, individuals with incomplete vaccination (primary series or COVID-19 booster).

Exclusion Criteria:

• Persons fully vaccinated for COVID-19 (including primary series and boosters), persons with any documented allergies to components of the COVID-19 vaccines, or contraindications to receiving a COVID-19 vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing; Vaccine education will be focused on addressing misinformation and concerns in a culturally competent manner with referral to resources. The vaccine education model will be translated to reach minority groups including African Americans, Vietnamese Americans and Hispanic Americans.

Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing; A rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel. The intervention will include: 1) 15 minute vaccine counseling, 2) print material 3) referral to a dedicated vaccine website with feedback forums and 4) opportunity to sign-up for one-on-one vaccine counseling with a clinical pharmacist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccine Completion	COVID-19 vaccination verified by the Louisiana Links© system	9 months intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine Hesitancy Likelihood Scale	Measured on a 5-point scale indicating likelihood to be vaccinated. The scale ranges from 1 (Not at all likely to be vaccinated), 2 (Not likely to be vaccinated), 3 (No opinion/Undecided about vaccination), 4 (Likely to be vaccinated) to 5 (Very likely to be vaccinated)	9 months post intervention

Collaborators and Investigators

• Sponsor: Xavier University of Louisiana.
• Investigators: Principal Investigator: Sara Al-Dahir, PharmD, Xavier University of Louisiana.; Principal Investigator: Klaus Heyer, PhD, Nunez Community College

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Healthcare Disparities; Vaccine Completion; COVID19 Testing; COVID19 Education; Point of Care Testing; Healthcare Personnel Education
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB850-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No