Equitable Access to COVID-19 Vaccines

March 17, 2022 updated by: Chyke A. Doubeni, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

1722

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short message service (SMS)
Subjects will receive vaccine availability and appointment information via SMS.
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
Experimental: Personalized text message
Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP).
Behavioral: 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
Experimental: Interactive or 2-way SMS
Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose 1 COVID-19 Vaccine
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose 2 COVID-19 Vaccine
Time Frame: 60 days
Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).
60 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement
Time Frame: 30 days
We will assess engagement with the 2-way SMS options as well as use of online appointment scheduling
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Adelante Healthcare

Investigators

  • Principal Investigator: Chyke Doubeni, MD, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

June 10, 2021

Study Completion (Actual)

June 10, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-002939

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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