InfluenzaNCT05537441

Precision Vaccine Promotion in Underserved Populations

A study testing Text messaging in people with Influenza and Vaccine Hesitancy, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 months and older
Conditions the study is for: Influenza, Vaccine Hesitancy
What is being tested?: Text messaging
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228,831 participants
Where: 1 siteUnited States
Study dates: 22 Sep 2022to 1 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Los Angeles County Department of Health Services (LACDHS) primary care patients over 6 months of age

Who cannot join

LACDHS patients less than 6 months of age

Trial locations and contacts

1 site in 1 country.

United States1 site

Los Angeles County Department of Health Services
Los Angeles, California, 90012

Other trials in United States

About this study

Previous studies have shown that low-cost, behavioral nudges through texting can increase influenza vaccination uptake compared to usual care. However, there are limited studies that evaluate the effect of decreasing barriers to scheduling, especially within safety net populations. The setting for this study, DHS, is the second largest public delivery system in the country and serves approximately half a million diverse patients that are eligible for vaccinations annually. This pilot study (one arm in a larger randomized controlled trial) will examine the effect of text messages highlighting MediCal health plan transportation resources (vs standard text messaging) on influenza vaccination rates in adults during the 2022-2023 flu season.

Conditions: Influenza, Vaccine Hesitancy
Being tested: Text messaging
Medical subject headings: Influenza, Human, Vaccination Hesitancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Text messagingBehavioural
Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.

Study groups in NCT05537441
Study group	Role	What they receive
Standard Texts	Active comparator	Patients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. Receives: Behavioral: Text messaging
Standard Texts with Transportation messaging	Experimental	Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#. Receives: Behavioral: Text messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Vaccinated at the End of the Campaign Period
Number of Participants who received their influenza vaccination during the campaign period, as measured in the California Immunization Registry (CAIR2) to include vaccinations occurring both inside and outside the LADHS system. We assessed baseline vaccination status at the beginning of the flu season and excluded individuals who already received their vaccination.
Measured: 6 months

Secondary outcomes (1)

Heterogeneity of Treatment Effects for Demographics
Heterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 20221 Jun 2023

First posted13 Sep 2022
Study start22 Sep 2022
Primary completion31 Mar 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
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
Masking: Single blind
Who is masked: Care provider
Enrolment: 228,831 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05537441
Sponsor's protocol ID: HS-22-00479
Other IDs: P30AG024968
Status last verified: Sep 2024
First submitted: 9 Sep 2022
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BPL-1357 Against H1N1 Influenza Virus Challenge
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RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
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Enrolling by invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precision Vaccine Promotion in Underserved Populations
ClinicalTrials.gov ID: NCT05537441
Acronym / sponsor ID: HS-22-00479
Conditions: Influenza, Vaccine Hesitancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 228,831 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), University of California, Los Angeles, Los Angeles County Department of Public Health
Study start: 22 Sep 2022 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 13 Sep 2022 (actual)
Results: Posted 1 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Standard Texts	Active comparator	Behavioral: Text messagingPatients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.
Standard Texts with Transportation messaging	Experimental	Behavioral: Text messagingPatients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Los Angeles County Department of Health Services (LACDHS) primary care patients over 6 months of age

Key exclusion criteria (1 listed)

LACDHS patients less than 6 months of age

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
Text messagingPatients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.	Behavioural	Standard Texts, Standard Texts with Transportation messaging

Primary outcome

Number of Participants Vaccinated at the End of the Campaign Period
Time frame: 6 months
Number of Participants who received their influenza vaccination during the campaign period, as measured in the California Immunization Registry (CAIR2) to include vaccinations occurring both inside and outside the LADHS system. We assessed baseline vaccination status at the beginning of the flu season and excluded individuals who already received their vaccination.

1 secondary outcome

Heterogeneity of Treatment Effects for Demographics
Time frame: 6 months

Results and safety

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Texts	224,959	224,959
Standard Texts With Transportation Messaging	3,872	3,872

Primary outcome: Number of Participants Vaccinated at the End of the Campaign Period

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Standard Texts n = 121743	Standard Texts With Transportation Messaging n = 3050
Value	33357	854

Standard Texts: Percent Difference: .64, p = 0.216, 2 proportion Z-test

Population analysed: As not all randomized participants were eligible for the transportation messaging given their insurance did not cover healthcare transportation costs, these households were removed from both groups.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months following messaging intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Texts	0 of 121,743 (0%)	0 of 121,743 (0%)	0 of 121,743
Standard Texts With Transportation Messaging	0 of 3,050 (0%)	0 of 3,050 (0%)	0 of 3,050

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Influenza

RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
Enrolling by invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza

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.

Daniella Meeker, PhD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text messaging in people with Influenza and Vaccine Hesitancy, run by University of Southern California 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?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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 1 Oct 2024. 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?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Vaccinated at the End of the Campaign Period (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537441.

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 1 Oct 2024.