Equitable Access to COVID-19 Vaccines

Study Overview
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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: 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.

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

Conditions
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Covid19

Intervention / Treatment
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* Behavioral: SMS delivery of information
* Behavioral: Personalized text message delivery of information
* Behavioral: Interactive or 2-way SMS delivery of information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short message service (SMS)<br>Subjects will receive vaccine availability and appointment information via SMS. | Behavioral: SMS delivery of information<br>* 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<br>|
| Experimental: Personalized text message<br>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<br>* 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<br>|
| Experimental: Interactive or 2-way SMS<br>Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options. | Behavioral: Interactive or 2-way SMS delivery of information<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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