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

Primary Purpose

Covid19, Vaccine Refusal, Vaccine Hesitancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 Vaccine Education at the Point of COVID-19 Testing
Sponsored by
Xavier University of Louisiana.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Vaccine Completion, COVID19 Testing, COVID19 Education, Point of Care Testing, Healthcare Personnel Education, Healthcare Disparities

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xavier University of LouisianaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing

Arm Description

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.

Outcomes

Primary Outcome Measures

COVID-19 Vaccine Completion
COVID-19 vaccination verified by the Louisiana Links© system

Secondary Outcome Measures

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)

Full Information

First Posted
June 22, 2021
Last Updated
May 10, 2023
Sponsor
Xavier University of Louisiana.
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1. Study Identification

Unique Protocol Identification Number
NCT04939506
Brief Title
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana
Official Title
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xavier University of Louisiana.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccine Refusal, Vaccine Hesitancy
Keywords
Vaccine Completion, COVID19 Testing, COVID19 Education, Point of Care Testing, Healthcare Personnel Education, Healthcare Disparities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 Vaccine Education at the Point of COVID-19 Testing
Intervention Description
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
Primary Outcome Measure Information:
Title
COVID-19 Vaccine Completion
Description
COVID-19 vaccination verified by the Louisiana Links© system
Time Frame
9 months intervention
Secondary Outcome Measure Information:
Title
Vaccine Hesitancy Likelihood Scale
Description
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)
Time Frame
9 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Al-Dahir, PharmD
Phone
5045205766
Email
saaldah@xula.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Belkhouche, PharmD
Phone
5049130315
Email
mbelkhou@xula.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Al-Dahir, PharmD
Organizational Affiliation
Xavier University of Louisiana.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xavier University of Louisiana
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Al-Dahir, PharmD, PhD
Phone
504-520-5766
Email
saaldah@xula.edu
First Name & Middle Initial & Last Name & Degree
Mohamed Belkhouche, MA
Phone
5049130315
Email
mbelkhou@xula.edu
First Name & Middle Initial & Last Name & Degree
Ashley Taylor, PharmD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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