Covid19NCT04939506
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana
A study testing COVID-19 Vaccine Education at the Point of COVID-19 Testing in people with Covid19 and Vaccine Refusal, run by Xavier University of Louisiana. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vaccine Refusal, Vaccine Hesitancy
- What is being tested?
- COVID-19 Vaccine Education at the Point of COVID-19 Testing
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Xavier University of Louisiana
New Orleans, Louisiana, 70125
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Vaccine Refusal, Vaccine Hesitancy
- Being tested
- COVID-19 Vaccine Education at the Point of COVID-19 Testing
- Keywords
- Vaccine Completion, COVID19 Testing, COVID19 Education, Point of Care Testing, Healthcare Personnel Education, Healthcare Disparities
- Medical subject headings
- COVID-19, Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Vaccine Education at the Point of COVID-19 TestingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months intervention
Secondary outcomes (1)
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)
Measured: 9 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Sep 2022
- Primary completion30 Nov 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xavier University of Louisiana.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Sara Al-Dahir, PharmD, Principal investigator, Xavier University of Louisiana.Klaus Heyer, PhD, Principal investigator, Nunez Community College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939506
- Sponsor's protocol ID
- IRB850-21
- Other IDs
- 3U54MD007595-13S3
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2021
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana
- ClinicalTrials.gov ID
- NCT04939506
- Acronym / sponsor ID
- IRB850-21
- Conditions
- Covid19, Vaccine Refusal, Vaccine Hesitancy
- Keywords
- Vaccine Completion, COVID19 Testing, COVID19 Education, Point of Care Testing, Healthcare Personnel Education, Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Xavier University of Louisiana.University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 21 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing | Experimental | Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 TestingVaccine 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Vaccine Education at the Point of COVID-19 TestingA 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 | Behavioural | Participants Which Receive COVID-19 Vaccine Education at the Point of COVID-19 Testing |
Primary outcome
COVID-19 Vaccine Completion Upon Education
Time frame: 9 months intervention
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.
1 secondary outcome
Vaccine Hesitancy Likelihood Scale
Time frame: 9 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Al-Dahir, PharmD principal investigator
Xavier University of Louisiana.
Klaus Heyer, PhD principal investigator
Nunez Community College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Vaccine Education at the Point of COVID-19 Testing in people with Covid19 and Vaccine Refusal, run by Xavier University of Louisiana. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Vaccine Completion Upon Education (time frame: 9 months intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.