NCT04939506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
379

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

June 22, 2021

Last Update Submit

February 21, 2024

Conditions

Keywords

Vaccine CompletionCOVID19 TestingCOVID19 EducationPoint of Care TestingHealthcare Personnel EducationHealthcare Disparities

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Vaccine Completion

    COVID-19 vaccination verified by the Louisiana Links© system

    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

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

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

COVID-19Vaccination RefusalVaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sara Al-Dahir, PharmD

    Xavier University of Louisiana.

    PRINCIPAL INVESTIGATOR
  • Klaus Heyer, PhD

    Nunez Community College

    PRINCIPAL INVESTIGATOR

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

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations