Equitable Access to COVID-19 Vaccines

Covid19 Clinical Trial

Official title:

Enabling Equitable Access to COVID-19 Vaccine in Under-Resourced Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952376
• Other study ID #: 21-002939
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: March 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations and address vaccine hesitancy to improve access by using a proactive organized population-based outreach leveraging health information technology with tailored navigation support to address mistrust and social barriers.

Description:

This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations through a proactive organized population-based outreach approach. It will leverage health information technology with tailored navigation support to address mistrust and social barriers. Study key objectives are to:

1. conduct a survey of patients to assess and track barriers, intent, and sources of information on COVID vaccine over time.

2. Determine whether a primary care physician (PCP) endorsement with or without interactive digital communication plus navigation is more effective in promoting uptake of COVID-19 vaccine than general messages from the clinic. Patients will be randomized to one of three arms:

1. Arm 1: Message about vaccine availability delivered by SMS advising patients to make an appointment.

2. Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP.

3. Arm 3: Same as Arm 2 plus a interactive 2-way SMS options.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1722
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: 18 years and older, receiving care at Adelante Healthcare and not vaccinated or already scheduled for vaccination through the health center's appointment system Exclusion Criteria: Patient younger than 18 or who have been previously or are selected for vaccination during or prior to the week of study enrollment

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• SMS delivery of information
Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. Links to information or phone for scheduling will be provided. Messages mimic the clinic's usual practice of information delivery to patients
• Personalized text message delivery of information
Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. The SMS message is personalized as a recommendation from the primary care clinician
• Interactive or 2-way SMS delivery of information
This intervention is same as in the Arm 2 using personalized messaging from the PCP. In addition, patients are given interactive or 2-way SMS options to obtain additional information about COVID vaccine and answers to frequently asked questions.

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Adelante Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Engagement	We will assess engagement with the 2-way SMS options as well as use of online appointment scheduling	30 days
Primary	Dose 1 COVID-19 Vaccine	Primary outcome will be the receipt of the first dose of any of the COVID-19 vaccines with FDA emergency use authorization	30 days
Secondary	Dose 2 COVID-19 Vaccine	Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).	60 days

External Links

•   Mayo Clinic Clinical Trials