mivacunaLA (myshotLA) 2.0: A community-based digital intervention to improve COVID-19 vaccination behaviors among Hispanic Children

Last registered on May 03, 2023

Pre-Trial

Trial Information

General Information

Title
mivacunaLA (myshotLA) 2.0: A community-based digital intervention to improve COVID-19 vaccination behaviors among Hispanic Children
RCT ID
AEARCTR-0011339
Initial registration date
April 27, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 03, 2023, 4:25 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
Pepperdine University

Other Primary Investigator(s)

PI Affiliation
Cedars-Sinai

Additional Trial Information

Status
On going
Start date
2022-05-01
End date
2023-12-31
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
Objectives. To evaluate a community-informed mobile phone intervention (mivacunaLA/myshotLA) to increase COVID-19 vaccination among Latino families in communities with low vaccine uptake and high rates of COVID-19 transmission.
Methods. We conducted a randomized controlled trial with a wait-list control group among Latino parents/caregivers with at least one unvaccinated child in East and South Los Angeles in the fall of 2022 to measure the effectiveness of mivacunaLA, a community-partnered intervention to promote vaccine uptake by addressing misinformation and building trust.
Results. Analysis in progress. We plan analyze the impact of our program on COVID-19 vaccine uptake among children in 3 age groups: 1) 6 months to 4 years old, 2) 5 to 11 years old, and 3) 12 to 17 years old.
External Link(s)

Registration Citation

Citation
Blanco Raynal, Luisa and Yelba Castellon-Lopez. 2023. "mivacunaLA (myshotLA) 2.0: A community-based digital intervention to improve COVID-19 vaccination behaviors among Hispanic Children ." AEA RCT Registry. May 03. https://doi.org/10.1257/rct.11339-1.0
Experimental Details

Interventions

Intervention(s)
We implemented a community-based digital intervention to provide educational information paired with local COVID-19 vaccination resources. This intervention was an improved version of mivacunaLA 1.0 intervention (this trial is also registered in this registry). Improvements to our intervention were informed by focus groups and feedback from our community partner organizations and parent leaders. Our intervention provided reliable information and resources about the COVID-19 vaccine for children. To increase trust and accommodate individuals with lower health literacy, we provided videos delivered by Latino/a physicians and promotoras (community health workers) encouraging vaccination and sharing their personal testimony. Our program was a 4 week program, where participants received three text messages per week that invited them to watch a video and read information related to COVID-19 vaccines for children. For this intervention we also added the following components
1) online discussion board where participants could ask questions about COVID-19 vaccines and they will be answered by a health expert.
2) online seminar conducted by Dr. Yelba Castellon
3) final community event
Intervention Start Date
2022-08-01
Intervention End Date
2022-12-31

Primary Outcomes

Primary Outcomes (end points)
1) COVID-19 vaccination status of children 12-17 years old in household (self-reported)
2) COVID-19 vaccination status of children 5-11 years old in household (self-reported)
3) COVID-19 vaccination status of children 6 months to 4 years old in household (self-reported)
Primary Outcomes (explanation)
Our primary outcomes were (1) changes in COVID-19 vaccination status among minors for different age groups. All age groups considered here had access to the COVID-19 vaccine when our intervention was in the field. We assumed vaccination status of multiple minors within the same age range and household to be consistent, resulting in one outcome variable per age range and household. The measures were adapted from those use in the Understanding America Study to be specific to children. COVID-19 vaccination status for minors 12-17 years and COVID-19 vaccination behaviors for minors 2-11 years in the household were collected among treatment and control groups at baseline and one month.

Secondary Outcomes

Secondary Outcomes (end points)
COVID-19 vaccine knowledge
Usefulness of mivacunaLA 2.0 material
Familiarity of mivacunaLA 2.0 material
Secondary Outcomes (explanation)
1) COVID-19 vaccine knowledge: we asked several questions related to vaccine knowledge such as perceptions on whether vaccine reduces probability to die from COVID
2) Usefulness of mivacunaLA material: we asked participants how useful was the information reviewed in each week
3) Familiarity of mivacunaLA material: we asked participants how familiar they were with the information reviewed in each week

Experimental Design

Experimental Design
We conducted mivacunaLA 2.0 community-based randomized controlled trial (RCT) with a wait-list control group to ensure that all participants could benefit from the intervention. Thus, the treatment group received the intervention in month 1, and the control group received the intervention in month 2.
Experimental Design Details
Randomization Method
We randomize participants into treatment and control group using a randomizer in a computer.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
NA
Sample size: planned number of observations
We invited 512 parents or caregivers of children to participate in program and that met the screening criteria.
Sample size (or number of clusters) by treatment arms
We had 298 parents/caregivers to complete consent and baseline survey.
146 were assigned to the treatment group and 152 were assigned to the wait-list control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
UCLA Institutional Review Board
IRB Approval Date
2022-07-30
IRB Approval Number
21-000857

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials