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Precision Vaccine Promotion in Underserved Populations

Precision Vaccine Promotion in Underserved Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05537441
Enrollment
228831
Registered
2022-09-13
Start date
2022-09-22
Completion date
2023-06-01
Last updated
2024-10-01

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

Conditions

Influenza, Vaccine Hesitancy

Brief summary

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.

Interventions

BEHAVIORALText messaging

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of California, Los Angeles
CollaboratorOTHER
Los Angeles County Department of Public Health
CollaboratorOTHER_GOV
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* LACDHS patients less than 6 months of age

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Vaccinated at the End of the Campaign Period6 monthsNumber 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.

Secondary

MeasureTime frameDescription
Heterogeneity of Treatment Effects for Demographics6 monthsHeterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated)

Countries

United States

Participant flow

Pre-assignment details

Only one household member (index person) is randomized and all other members receive the same message

Participants by arm

ArmCount
Standard Texts
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. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
121,743
Standard Texts With Transportation Messaging
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#. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
3,050
Total124,793

Baseline characteristics

CharacteristicStandard TextsStandard Texts With Transportation MessagingTotal
Age, Continuous45.27 years
STANDARD_DEVIATION 19.68
45.25 years
STANDARD_DEVIATION 19.78
45.27 years
STANDARD_DEVIATION 19.68
Ethnicity (NIH/OMB)
Hispanic or Latino
69637 Participants1741 Participants71378 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32141 Participants776 Participants32917 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
19965 Participants533 Participants20498 Participants
Region of Enrollment
United States
121743 Participants3050 Participants124793 Participants
Sex/Gender, Customized
Sex/Gender
Female
62819 Participants1595 Participants64414 Participants
Sex/Gender, Customized
Sex/Gender
Male
55271 Participants1363 Participants56634 Participants
Sex/Gender, Customized
Sex/Gender
Unknown/Not reported
3653 Participants92 Participants3745 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 121,7430 / 3,050
other
Total, other adverse events
0 / 121,7430 / 3,050
serious
Total, serious adverse events
0 / 121,7430 / 3,050

Outcome results

Primary

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.

Time frame: 6 months

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard TextsNumber of Participants Vaccinated at the End of the Campaign Period33357 Participants
Standard Texts With Transportation MessagingNumber of Participants Vaccinated at the End of the Campaign Period854 Participants
p-value: 0.2162 proportion Z-test
Secondary

Heterogeneity of Treatment Effects for Demographics

Heterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated)

Time frame: 6 months

Population: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Standard TextsHeterogeneity of Treatment Effects for DemographicsPreviously vaccinated44742 Participants
Standard TextsHeterogeneity of Treatment Effects for DemographicsPreviously unvaccinated77001 Participants
Standard Texts With Transportation MessagingHeterogeneity of Treatment Effects for DemographicsPreviously vaccinated1129 Participants
Standard Texts With Transportation MessagingHeterogeneity of Treatment Effects for DemographicsPreviously unvaccinated1921 Participants
Comparison: Previously vaccinatedp-value: 0.342 proportion Z-test
Comparison: Previously unvaccinatedp-value: 0.2472 proportion Z-test

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