Equitable Access to COVID-19 Vaccines
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMS delivery of information
Personalized text message delivery of information
Interactive or 2-way SMS delivery of information
Sponsored by

About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Short message service (SMS)
Personalized text message
Interactive or 2-way SMS
Arm Description
Subjects will receive vaccine availability and appointment information via SMS.
Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP).
Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Dose 2 COVID-19 Vaccine
Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).
Full Information
NCT ID
NCT04952376
First Posted
June 7, 2021
Last Updated
March 17, 2022
Sponsor
Mayo Clinic
Collaborators
Adelante Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04952376
Brief Title
Equitable Access to COVID-19 Vaccines
Official Title
Enabling Equitable Access to COVID-19 Vaccine in Under-Resourced Communities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Adelante Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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:
conduct a survey of patients to assess and track barriers, intent, and sources of information on COVID vaccine over time.
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:
Arm 1: Message about vaccine availability delivered by SMS advising patients to make an appointment.
Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP.
Arm 3: Same as Arm 2 plus a interactive 2-way SMS options.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Patient is informed via SMS of vaccine availability and advised to schedule an appointment.
Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP. Arm 3: Patients assigned to Arm 3 will receive the same message in the Arm 2 intervention. In addition, they will be given interactive or 2-way SMS options to obtain additional information about COVID vaccine.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1722 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short message service (SMS)
Arm Type
Active Comparator
Arm Description
Subjects will receive vaccine availability and appointment information via SMS.
Arm Title
Personalized text message
Arm Type
Experimental
Arm Description
Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP).
Arm Title
Interactive or 2-way SMS
Arm Type
Experimental
Arm Description
Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options.
Intervention Type
Behavioral
Intervention Name(s)
SMS delivery of information
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Personalized text message delivery of information
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Interactive or 2-way SMS delivery of information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose 1 COVID-19 Vaccine
Description
Primary outcome will be the receipt of the first dose of any of the COVID-19 vaccines with FDA emergency use authorization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Dose 2 COVID-19 Vaccine
Description
Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).
Time Frame
60 days
Other Pre-specified Outcome Measures:
Title
Engagement
Description
We will assess engagement with the 2-way SMS options as well as use of online appointment scheduling
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chyke Doubeni, MD, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Equitable Access to COVID-19 Vaccines
We'll reach out to this number within 24 hrs