NCT05234372

Brief Summary

The aim of this study is to determine whether a community-informed, linguistically and culturally tailored educational program delivered via mobile phone is effective in improving vaccination behaviors among Latino families. Thus we evaluate a community-based mobile phone intervention (mivacunaLA) to assess if there is an increase in vaccination rates among 12-17 year old children and willingness to vaccinate 2-11year old children who have not been previously vaccinated who reside in high-risk and low resourced neighborhoods in Los Angeles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
468

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

February 8, 2022

Last Update Submit

December 9, 2025

Conditions

COVID-19 Pandemic

Keywords

vaccination, vulnerable populations, health disparities

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome Measure: vaccination status among minors 12-17 years

    Changes in COVID-19 vaccination status among minors 12-17 years. Have the minor #X 12-17 years old in your household been vaccinated for the coronavirus? 1.Yes, 2.No, 3.Unsure Instrument similar used in the Understanding America Study

    1 month

  • Intent to vaccinate children 2-11 yrs old

    Change in willingness to vaccinate children 2-11 yrs old. f a vaccine against the coronavirus becomes available for children ages 2-11, do you plan to get them vaccinated?1.Yes, as soon as possible, 2.Yes, but I want to wait and see, 3.No, but I want to wait and see, 4.No, I will not get a coronavirus vaccine for my child, 5.Not sure. Positive answers:1.Yes, as soon as possible, 2.Yes, but I want to wait and see Not positive: 3.No, but I want to wait and see, 4.No, I will not get a coronavirus vaccine for my child, 5.Not sure Instrument adjusted from Understanding America Study.

    1 month

Study Arms (2)

Treatment received intervention at enrollment

EXPERIMENTAL

Participants received mobile phone delivered intervention at enrollment. The intervention had a duration of 4 weeks. Each week participants received two text messages inviting them to view a short video (Monday) and brief written content (Wed). Each week, the material consisted of a culturally tailored theme related to COVID-19 vaccination. Participants also received information on how to get vaccinated.

Behavioral: mivacunaLA

Control

OTHER

Wait-list control. No intervention during month 1. Received the intervention at Month 2. Each week, during the first month, participants received a text with a count down of how many days were left to begin the intervention.

Behavioral: mivacunaLA

Interventions

mivacunaLABEHAVIORAL

Based on their stated language preference in the baseline survey, eligible participants in the program received a text message or email twice a week (Monday and Wednesday at noon). The short text messages (\<160 characters in length) provided a link to a 2-3 min video (Monday) and a short educational content around 500 words (Wednesday). Content was organized by week with the following topics: 1) what is COVID-19 and how COVID-19 vaccines works, 2) COVID-19 vaccine myths and facts, 3) COVID-19 vaccine safety and efficacy in children, and 4) how to obtain COVID-19 vaccines in your community. Every week we provided information about how to get vaccines with links to local vaccine sites \& resources.

ControlTreatment received intervention at enrollment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identified as Latino/a,
  • were 18 years or older,
  • had at least one unvaccinated child of any age (17 or younger), and
  • had the means to receive messages and review educational material online, such as a text-capable mobile phone with internet access

You may not qualify if:

  • Unable to receive information via mobile text or computer.
  • Does not speak English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Pepperdine University

Malibu, California, 90263, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yelba M Castellon-Lopez, MD, MS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Luisa Blanco Raynal

    Pepperdine University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants were informed at enrollment what arm they belonged to. Investigators could see what arm participants were assigned to. Outcome assessors/data analysts was blinded.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: In collaboration with community partners, we designed mivacunaLA as an RCT with a wait-list control group to ensure that all participants could benefit from the educational intervention. The treatment group received the 1 month intervention upon enrollment and the wait-list control received the intervention at month 2 from enrollment. We propose to analyze baseline data for the primary outcomes related to adult caregiver behaviors regarding COVID-19 vaccination for children living in the household for 1 month outcomes, before the control group was exposed to the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 10, 2022

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

We have de-identified data available in excel and stata for analysis. Given that our data was collected among a vulnerable population and we did not obtain consent to share PHI at the study onset, with a large immigrant population recruited, our intent is to share de-identified data only through special request by investigators (will need approval by both co-PIs). Sharing of data would be pending approval of our institutional IRB.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
We will share by special request and pending IRB approval over the next two years.
Access Criteria
Researcher(s) will need to submit an application and it will be reviewed by the co-PIs.

Locations

US(2)