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Equitable Access to COVID-19 Vaccines

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04952376
Enrollment
1722
Registered
2021-07-07
Start date
2021-04-01
Completion date
2021-06-10
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

BEHAVIORALSMS 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

BEHAVIORALPersonalized 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

BEHAVIORALInteractive 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.

Sponsors

Adelante Healthcare
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dose 1 COVID-19 Vaccine30 daysPrimary outcome will be the receipt of the first dose of any of the COVID-19 vaccines with FDA emergency use authorization

Secondary

MeasureTime frameDescription
Dose 2 COVID-19 Vaccine60 daysExamine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).

Other

MeasureTime frameDescription
Engagement30 daysWe will assess engagement with the 2-way SMS options as well as use of online appointment scheduling

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026