Equitable Access to COVID-19 Vaccines

NCT ID: NCT04952376

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-06-10

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Short message service (SMS)

Subjects will receive vaccine availability and appointment information via SMS.

Group Type ACTIVE_COMPARATOR

SMS delivery of information

Intervention Type BEHAVIORAL

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

Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP).

Group Type EXPERIMENTAL

Personalized text message delivery of information

Intervention Type BEHAVIORAL

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

Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options.

Group Type EXPERIMENTAL

Interactive or 2-way SMS delivery of information

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adelante Healthcare

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Chyke A. Doubeni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chyke Doubeni, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-002939

Identifier Type: -

Identifier Source: org_study_id

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