Equitable Access to COVID-19 Vaccines

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Behavioral: Interactive or 2-way SMS delivery of information; Behavioral: SMS delivery of information; Behavioral: Personalized text message delivery of information

• Registration Number: NCT04952376
• Lead Sponsor: Mayo Clinic

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:

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-06-07
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1722

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive or 2-way SMS	Interactive or 2-way SMS delivery of information	Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options.
Short message service (SMS)	SMS delivery of information	Subjects will receive vaccine availability and appointment information via SMS.
Personalized text message	Personalized text message delivery of information	Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP).

Primary Outcome Measures

Name	Time	Method
Dose 1 COVID-19 Vaccine	30 days	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

Name	Time	Method
Dose 2 COVID-19 Vaccine	60 days	Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States