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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05234372
Other study ID # 21-000857
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date November 30, 2021

Study information

Verified date February 2022
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 468
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mivacunaLA
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.

Locations

Country Name City State
United States University of California Los Angeles Los Angeles California
United States Pepperdine University Malibu California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Pepperdine University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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