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

NCT04939506 | Completed Results DMC

• 2 other identifiers: IRB850-213U54MD007595-13S3
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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 using a rapid vaccine education model delivered at the point of care.

Conditions

Covid19; Vaccine Refusal; Vaccine Hesitancy

Keywords

Vaccine Completion; COVID19 Testing; COVID19 Education; Point of Care Testing; Healthcare Personnel Education; Healthcare Disparities

Outcome Measures

Primary Outcomes (1)

• COVID-19 Vaccine Completion Upon Education

  COVID-19 vaccination completion verified by the Louisiana LINKS© system, defined as receipt of all recommended doses of a COVID-19 vaccine during the 9-month intervention period following education at the point of COVID-19 testing.

  9 months intervention

Secondary Outcomes (1)

• Vaccine Hesitancy Likelihood Scale

  9 months post intervention

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

COVID-19 Vaccine Education at the Point of COVID-19 Testing BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xavier University of Louisiana.: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

COVID-19; Vaccination Refusal; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Sara Al-Dahir
• Organization: Xavier University of Louisiana

saaldah@xula.edu

(504) 520-7971

Study Officials

• Sara Al-Dahir, PharmD

  Xavier University of Louisiana.

  PRINCIPAL INVESTIGATOR

• Klaus Heyer, PhD

  Nunez Community College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: September 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: January 25, 2024
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)