Clinical trial NCT05676970: TeleHealth Model to Address Vaccine Hesitancy & Increase Vaccine Completion Among Communities in Southeastern Louisiana
Official title: Using a Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccine Hesitancy
Keywords: Vaccine Uptake
COVID-19 vaccine
Influenza vaccine
Lead sponsor: Xavier University of Louisiana.
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose to use a individually randomized group treatment trial design with a baseline survey to assess social determinants of health, COVID-19 experience and knowledge, baseline demographic information and vaccine hesitancy as relates to potential COVID-19 vaccine uptake in our target population. We will then randomize participants in a 1:1 fashion to a vaccine intervention arm and a control arm matched baseline vaccine hesitancy score. Given this is an IRGT (Individualized Randomized Group Treatment) trial design, a priori matching should assist in preventing a Type I error. Individuals will then complete 8 individual or group based behavioral health interventions via a Telehealth model conducted by a Clinical Pharmacist.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Incomplete vaccination defined as 1a. Incomplete COVID-19 vaccine series 1b. Incomplete COVID-19 booster or annual COVID-19 vaccine 1c. Incomplete annual influenza
2. Adults aged 18 years to 65 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 annual COVID-19 vaccine update.
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, primary immunodeficiency, or organ transplant recipients
5. Individuals diagnosed with congestive heart failure
6. Individuals diagnosed with any cardiac arrhythmia

Primary outcomes:
measure: COVID-19 Vaccine Series Completion
timeFrame: 1 year
measure: COVID-19 Vaccine Series Completion
timeFrame: Through study completion, on average, two years
Secondary outcomes:
measure: Influenza Vaccination Completion
timeFrame: 1 year
measure: Influenza Vaccination Completion
timeFrame: Through study completion, on average, two years
measure: Vaccine Hesitancy Scale
timeFrame: 1 year
measure: Vaccine Hesitancy Scale
timeFrame: Through study completion, on average, two years
measure: Change in Vaccine Hesitancy Scale
timeFrame: Through study completion, on average, two years
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Xavier University of Louisiana
state: Louisiana
Study officials:
affiliation: Xavier University of Louisiana.
name: Sara Al-Dahir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nunez Community College
name: Klaus Heyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: