TeleHealth Model to Address Vaccine Hesitancy & Increase Vaccine Completion Among Communities in Southeastern Louisiana

Using a Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana

This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.

Study Overview

• Status: Recruiting
• Conditions: Vaccine Hesitancy
• Intervention / Treatment: Behavioral: Telehealth: Wellness and Vaccination; Behavioral: TeleHealth: Wellness Only

Detailed Description

Individuals will be recruited using a community-based participatory research model to identify 525 patients to enter into an 24-30 month clinical pharmacist run, vaccine and health and wellness program delivered via Xavier's clinical pharmacy faculty trained in telehealth medicine using an individually randomized group treatment trial approach based upon industry of recruitment. Our recruitment will target enrollment of: 65% African-Americans, 10% Hispanic and 20% rural, with overlapping categories as necessary. Participants will be recruited from target high risk industries for COVID-19 infection: hospitality and food industry, plant workers, nurse's aides, teacher's aides and the beauty industries. Participants will complete a minimum of three individual visits and group informational visits. Both arms of the study will receive health and wellness visits. Only the vaccine intervention arm will receive the vaccine and counseling. Changes in vaccine hesitancy and monitoring for vaccine completion will occur by the clinical pharmacist via patient interviews and Links© access. The primary outcome will be completed COVID-19 vaccination series (primary series + applicable boosters). The secondary outcome will be completed influenza vaccine.

Impact: The implications of this proposed project are to understand health related beliefs and behaviors related to vaccination and vaccine hesitancy in the context of a general health and wellness model. This intervention approach aims to decrease vaccine disparities among vulnerable individuals. It will provide data to develop strategies to improve vaccination, especially COVID-19 vaccination, in vulnerable communities using pharmacy students and pharmacists. This grant will facilitate training early stage investigators and diversify the health research workforce as the researchers are underrepresented minorities and women.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Al-Dahir, PharmD, PhD; Phone Number: 504525766; Email: saaldah@xula.edu
• Study Contact Backup: Name: Saba Barri, MPH; Phone Number: 5042504537; Email: sbarri@xula.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70125
      • Recruiting
      • Xavier University of Louisiana
      • Contact: Sara Al-Dahir, PharmD; Phone Number: 504-520-5766; Email: saaldah@xula.edu
      • Contact: PharmD
      • Principal Investigator: Sara Al-Dahir, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Incomplete vaccination defined as 1a. Incomplete COVID-19 vaccine series 1b. Incomplete COVID-19 booster 1c. Incomplete annual influenza
2. Adults aged 18 years to 55 years of age
3. Able to speak English
4. Currently employed or seeking training in target industries such as: healthcare, education, beauty, hospitality, food (culinary) and industrial plant workers.
5. Able to use Telehealth technology via tablet, cell phone, or computer

Exclusion Criteria:

1. Individuals who have completed the COVID-19 vaccine series and boosters.
2. Individuals with documented allergy or reaction to COVID-19 or influenza vaccine
3. Individuals who are unable to give informed consent.
4. Individuals with diagnosis of immunosuppressive conditions such as cancer, lupus, rheumatoid arthritis, Crohn's disease, Ulcerative Colitis, primary immunodeficiency, or organ transplant recipients
5. Individuals diagnoses with congestive heart failure
6. Individuals diagnosed with any cardiac arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Arm: Wellness with Vaccine Education; Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group.	Behavioral: Telehealth: Wellness and Vaccination; Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group.
Active Comparator: Telehealth Arm: Wellness Only; Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group.	Behavioral: TeleHealth: Wellness Only; Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccine Series Completion	Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed)	1 year
COVID-19 Vaccine Series Completion	Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed)	Through study completion, on average, two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza Vaccination Completion	Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (per vaccine year)	1 year
Influenza Vaccination Completion	Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (Binary: Completed or not completed)	Through study completion, on average, two years
Vaccine Hesitancy Scale	Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine (Binary: Completed or not completed)	1 year
Vaccine Hesitancy Scale	Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine	Through study completion, on average, two years
Change in Vaccine Hesitancy Scale	Change from Baseline to Study Completion Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine	Through study completion, on average, two years

Collaborators and Investigators

• Sponsor: Xavier University of Louisiana.
• Investigators: Principal Investigator: Klaus Heyer, PhD, Nunez Community College; Principal Investigator: Sara Al-Dahir, PhD, Xavier University of Louisiana.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Influenza vaccine; COVID-19 vaccine; Vaccine Uptake
• Other Study ID Numbers: IRB938-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, we will share our intervention and information below.
• IPD Sharing Time Frame: After completion of study.
• IPD Sharing Access Criteria: Approval by Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No