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NCT05676970 | RECRUITING | Vaccine Hesitancy


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

Xavier University of Louisiana.

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.

Condition or disease

Vaccine Hesitancy

Intervention/treatment

Telehealth: Wellness and Vaccination

TeleHealth: Wellness Only

Phase

NA

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
Estimated Enrollment : 360 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Using a Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana
Actual Study Start Date : 2024-01-01
Estimated Primary Completion Date : 2028-12-01
Estimated Study Completion Date : 2028-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT05676970


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How to Participate

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Locations


RECRUITING

United States, Louisiana

Xavier University of Louisiana

New Orleans, Louisiana, United States, 70125

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