MivacunaLA (myshotLA) 1.0: a community-based digital intervention to improve COVID-19 vaccination behaviors among Hispanics

Last registered on May 03, 2023

Pre-Trial

General Information

Title

RCT ID

AEARCTR-0010942

Initial registration date

April 26, 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, 4:18 PM EDT

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

Locations

Country

United States of America

Region

CALIFORNIA

Primary Investigator

Name

Luisa Blanco Raynal

Affiliation

Pepperdine University

Contact Primary Investigator

Other Primary Investigator(s)

PI Name

Yelba Castellon-Lopez

PI Affiliation

Cedars-Sinai

Contact Investigator

Additional Trial Information

Status

Completed

Start date

2021-06-01

End date

2021-12-31

Keywords

Behavior, Health

Additional Keywords

vaccine hesitancy, vaccine trust

JEL code(s)

I12, I18

Secondary IDs

Prior work

This trial does not extend or rely on any 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 summer of 2021 to measure the effectiveness of mivacunaLA, a community-partnered intervention to promote vaccine uptake by addressing misinformation and building trust.
Results. A difference-in-difference analysis showed that Latino parents/caregivers that participated in mivacunaLA/myshotLA (n=246) were 12% points more likely (p=0.03) to report a positive intention to vaccinate their children aged 2-11 (when COVID-19 vaccines became available) and 15% points more likely (p=0.04) to report vaccination of their children aged 12-17, than controls.
Conclusions. Mobile phone delivered interventions using videos and culturally tailored educational material to promote COVID-19 vaccine confidence appears to be an effective way to combat misinformation and deliver timely information to marginalized communities. Community partnerships in research are important to advance health equity among those impacted most by the COVID-19 pandemic.

External Link(s)

Registration Citation

Citation

Blanco Raynal, Luisa and Yelba Castellon-Lopez. 2023. "MivacunaLA (myshotLA) 1.0: a community-based digital intervention to improve COVID-19 vaccination behaviors among Hispanics." AEA RCT Registry. May 03. https://doi.org/10.1257/rct.10942-1.0

Sponsors & Partners

Interventions

Intervention(s)

We created a community-based digital intervention to provide educational information paired with local COVID-19 vaccination resources informed by our Community Advisory Board (CAB) of Latino serving community organization leaders and Latino parents in East and South Los Angeles.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 two text messages per week that invited them to watch a video and read information related to COVID-19 vaccines for children.

Intervention (Hidden)

Intervention Start Date

2021-06-01

Intervention End Date

2021-12-31

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 intention of children 2-11 years old in household (self-reported)

Primary Outcomes (explanation)

Our primary outcomes were (1) changes in COVID-19 vaccination status among minors 12-17 years and (2) changes in intent to vaccinate minors 2-11 years old (authorization for COVID-19 vaccination for minors younger than 12 years was not available during the time of the study in the summer of 2021). We assumed intent to vaccinate/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 material
Familiarity of mivacunaLA 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

We conducted mivacunaLA 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 used separate block randomization for July and August of 2021 cohorts. Participants were randomized to either receive intervention at month 1 (treatment) or at month 2 (control). All participants completed a baseline survey and a follow-up survey at one month.

Randomization Unit

individual

Was the treatment clustered?

Experiment Characteristics

Sample size: planned number of clusters

Not applicable

Sample size: planned number of observations

468 parents or caregivers to participate in mivacunaLA were invited to participate. 366 participants completed the online informed consent and baseline survey and were assigned to treatment and control group.

Sample size (or number of clusters) by treatment arms

175 participants assigned to treatment group and 191 participants assigned to wait-list control group

Minimum detectable effect size for main outcomes (accounting for sample design and clustering)

With an effect size of 9% (estimated using differences between Latinos and Whites in Los Angeles according to UAS data in March 2021, according to our initial power calculation with a statistical power of 80%, we would need 319 participants in each arm (total of 638).

Supporting Documents and Materials

Documents

Document Name

mivacunaLA Protocol

Document Type

other

Document Description

Description of study.

File

mivacunaLA Protocol

MD5: 74646a38ee1e104c64dfec8ebc92159f

SHA1: 06a6ed3afbcbb9f22816d7d8d26a26fdacedbc61

Uploaded At: April 26, 2023

IRB

Institutional Review Boards (IRBs)

IRB Name

University of California Los Angeles Institutional Review Board

IRB Approval Date

2021-05-30

IRB Approval Number

21-06-1605

IRB Name

Pepperdine University Graduate and Professional Schools (GPS) Institutional Review Board

IRB Approval Date

2021-08-31

IRB Approval Number

21-06-1605

Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?

Yes

Intervention Completion Date

December 31, 2021, 12:00 +00:00

Data Collection Complete

Yes

Data Collection Completion Date

December 31, 2021, 12:00 +00:00

Final Sample Size: Number of Clusters (Unit of Randomization)

not applicable

Was attrition correlated with treatment status?

Yes

Final Sample Size: Total Number of Observations

366 participants completed the online informed consent and baseline survey

Final Sample Size (or Number of Clusters) by Treatment Arms

175 participants assigned to treatment group and 191 assigned to control group at the beginning of study (participants who completed consent and initial survey were assigned to these groups). 104 in the treatment group and 142 in the control group at month 1 (analytical sample, TOT analysis)

Data Publication

Is public data available?

Program Files

Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials

Description

Policy Brief

Citation

File

POLICY BRIEF- MiVacunaLA-v2.pdf

MD5: 34ff7a5630ee87c5f2399d45df54d698

SHA1: 83ff4a049958301c5505bc4605ec14fbdbf5c250

Uploaded At: April 26, 2023