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

Vaccine Hesitancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676970
• Other study ID #: IRB938-24
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2028

Study information

• Verified date: February 2024
• Source: Xavier University of Louisiana.
• Contact: Sara Al-Dahir, PharmD, PhD
• Phone: 504525766
• Email: saaldah[@]xula.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 30, 2028
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Xavier University of Louisiana	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Xavier University of Louisiana.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Influenza Vaccination Completion	Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (per vaccine year)	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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