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OpenTrials
Completed

NCT Number: NCT04952376

Equitable Access to COVID-19 Vaccines

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS delivery of information

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 delivery of information

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 delivery of information

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Dose 2 COVID-19 Vaccine

    Time frame: 60 days

    Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).

Other outcomes

  1. Engagement

    Time frame: 30 days

    We will assess engagement with the 2-way SMS options as well as use of online appointment scheduling

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Adelante Healthcare

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2021
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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