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

Sponsor

Xavier University of Louisiana. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04939506

Collaborator

(none)

375

Enrollment

Location

Arm

Anticipated Duration (Months)

22.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Vaccine Refusal Vaccine Hesitancy	Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

375 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

COVID-19 Vaccine Completion [9 months intervention]
COVID-19 vaccination verified by the Louisiana Links© system

Secondary Outcome Measures

Vaccine Hesitancy Likelihood Scale [9 months post intervention]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in English, Spanish or Vietnamese.

Exclusion Criteria:

Persons fully or partially vaccinated for COVID-19, persons with any documented allergies to components of the COVID-19 vaccines, or contraindications to receiving a COVID-19 vaccine.