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

Study Overview
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Brief Summary
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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
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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.

Official Title
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MyVaccineLA/MiVacunaLA: A Mobile Phone Delivered Intervention to Improve COVID-19 Vaccination Behaviors Among Vulnerable Latino Families in Los Angeles

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Behavioral: mivacunaLA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment received intervention at enrollment<br>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<br>* 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.<br>|
| Other: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, vulnerable populations, health disparities