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MiVacunaLA: an Intervention to Improve COVID-19 Vaccination Behaviors Among Latinos

Primary Purpose

COVID-19 Pandemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mivacunaLA
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Pandemic focused on measuring vaccination, vulnerable populations, health disparities

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of California Los Angeles
  • Pepperdine University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment received intervention at enrollment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2022
Last Updated
February 8, 2022
Sponsor
University of California, Los Angeles
Collaborators
Pepperdine University
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1. Study Identification

Unique Protocol Identification Number
NCT05234372
Brief Title
MiVacunaLA: an Intervention to Improve COVID-19 Vaccination Behaviors Among Latinos
Official Title
MyVaccineLA/MiVacunaLA: A Mobile Phone Delivered Intervention to Improve COVID-19 Vaccination Behaviors Among Vulnerable Latino Families in Los Angeles
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Pepperdine University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
We conducted a community-based randomized clinical trial with a wait list control group among adult Latino parents or caregivers in East and South Los Angeles. Participants completed an online demographic and baseline survey and were randomly assigned to treatment or wait-list control. Based on their preference, participants received a weekly text message or email link twice a week for four weeks (Mon and Wed at noon). Twice a week messages consisted of a short text (<160 characters) linking participants to a 2-3 minute video (Monday) and educational text (around 500 words in length. The material was divided into weekly topics regarding the coronavirus vaccine and other topics relevant to the Latino community. Participants were also directed to reliable websites where they could access additional information and links with instructions on where to get vaccinated. Upon completing the intervention, participants completed a 1-month follow-up survey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
Keywords
vaccination, vulnerable populations, health disparities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment received intervention at enrollment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mivacunaLA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome Measure: vaccination status among minors 12-17 years
Description
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
Time Frame
1 month
Title
Intent to vaccinate children 2-11 yrs old
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unable to receive information via mobile text or computer. Does not speak English or Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelba M Castellon-Lopez, MD, MS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luisa Blanco Raynal
Organizational Affiliation
Pepperdine University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pepperdine University
City
Malibu
State/Province
California
ZIP/Postal Code
90263
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
We will share by special request and pending IRB approval over the next two years.
IPD Sharing Access Criteria
Researcher(s) will need to submit an application and it will be reviewed by the co-PIs.

Learn more about this trial

MiVacunaLA: an Intervention to Improve COVID-19 Vaccination Behaviors Among Latinos

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