NCT04952376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,722

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

June 7, 2021

Last Update Submit

March 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dose 2 COVID-19 Vaccine

    60 days

Other Outcomes (1)

  • Engagement

    30 days

Study Arms (3)

Short message service (SMS)

ACTIVE COMPARATOR

Subjects will receive vaccine availability and appointment information via SMS.

Behavioral: SMS delivery of information

Personalized text message

EXPERIMENTAL

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

Interactive or 2-way SMS

EXPERIMENTAL

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

Behavioral: Interactive or 2-way SMS delivery of information

Interventions

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

Short message service (SMS)

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

Personalized text message

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.

Interactive or 2-way SMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Chyke Doubeni, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2021

First Posted

July 7, 2021

Study Start

April 1, 2021

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations