Covid19NCT04952376
Equitable Access to COVID-19 Vaccines
A study testing SMS delivery of information, Personalized text message delivery of information and Interactive or 2-way SMS delivery of information in people with Covid19, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SMS delivery of information, Personalized text message delivery of information and Interactive or 2-way SMS delivery of information
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,722 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enabling Equitable Access to COVID-19 Vaccine in Under-Resourced Communities
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.
Read the 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:
- 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.
- Conditions
- Covid19
- Being tested
- SMS delivery of information, Personalized text message delivery of information, Interactive or 2-way SMS delivery of information
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS delivery of informationBehavioural
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 informationBehavioural
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 informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Short message service (SMS) | Active comparator | Subjects will receive vaccine availability and appointment information via SMS. Receives: 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). Receives: 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. Receives: Behavioral: Interactive or 2-way SMS delivery of information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Dose 2 COVID-19 Vaccine
Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Apr 2021
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Adelante Healthcare
- Responsible party
- Principal investigator, Chyke A. Doubeni, Mayo Clinic
- Investigators
- Chyke Doubeni, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952376
- Sponsor's protocol ID
- 21-002939
- Status last verified
- Mar 2022
- First submitted
- 7 Jun 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Equitable Access to COVID-19 Vaccine in Under-Resourced Communities
- ClinicalTrials.gov ID
- NCT04952376
- Acronym / sponsor ID
- 21-002939
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,722 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Adelante Healthcare
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Short message service (SMS) | Active comparator | Behavioral: SMS delivery of informationSubjects will receive vaccine availability and appointment information via SMS. |
| Personalized text message | Experimental | Behavioral: Personalized text message delivery of informationSubjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP). |
| Interactive or 2-way SMS | Experimental | Behavioral: Interactive or 2-way SMS delivery of informationSubjects will receive vaccine availability and appointment information via interactive 2-way SMS options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS delivery of informationPatients 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 | Behavioural | Short message service (SMS) |
| Personalized text message delivery of informationPatients 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 | Behavioural | Personalized text message |
| Interactive or 2-way SMS delivery of informationThis 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. | Behavioural | Interactive or 2-way SMS |
Primary outcome
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
1 secondary outcome
Dose 2 COVID-19 Vaccine
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chyke Doubeni, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS delivery of information, Personalized text message delivery of information and Interactive or 2-way SMS delivery of information in people with Covid19, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose 1 COVID-19 Vaccine (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.