COVID-19 PandemicNCT05234372
MiVacunaLA: an Intervention to Improve COVID-19 Vaccination Behaviors Among Latinos
A study testing mivacunaLA in people with COVID-19 Pandemic, run by Cedars-Sinai Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- mivacunaLA
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to receive information via mobile text or computer.
- Does not speak English or Spanish.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Los Angeles
Los Angeles, California, 90095
Pepperdine University
Malibu, California, 90263
About this study
Official title: MyVaccineLA/MiVacunaLA: A Mobile Phone Delivered Intervention to Improve COVID-19 Vaccination Behaviors Among Vulnerable Latino Families in Los Angeles
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.
Read the 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.
- Conditions
- COVID-19 Pandemic
- Being tested
- mivacunaLA
- Keywords
- vaccination, vulnerable populations, health disparities
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mivacunaLABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment received intervention at enrollment | Experimental | 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. Receives: Behavioral: mivacunaLA |
| Control | Other | 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. Receives: Behavioral: mivacunaLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pepperdine University
- Responsible party
- Principal investigator, Yelba Castellon-Lopez, Cedars-Sinai Medical Center
- Investigators
- Yelba M Castellon-Lopez, MD, MS, Principal investigator, University of California, Los AngelesLuisa Blanco Raynal, Principal investigator, Pepperdine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234372
- Sponsor's protocol ID
- 21-000857
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyVaccineLA/MiVacunaLA: A Mobile Phone Delivered Intervention to Improve COVID-19 Vaccination Behaviors Among Vulnerable Latino Families in Los Angeles
- ClinicalTrials.gov ID
- NCT05234372
- Acronym / sponsor ID
- 21-000857
- Conditions
- COVID-19 Pandemic
- Keywords
- vaccination, vulnerable populations, health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Pepperdine University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment received intervention at enrollment | Experimental | Behavioral: mivacunaLAParticipants 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. |
| Control | Other | Behavioral: mivacunaLAWait-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to receive information via mobile text or computer.
- Does not speak English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mivacunaLABased 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. | Behavioural | Control, Treatment received intervention at enrollment |
Primary outcome
Primary Outcome Measure: vaccination status among minors 12-17 years
Time frame: 1 month
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
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelba M Castellon-Lopez, MD, MS principal investigator
University of California, Los Angeles
Luisa Blanco Raynal principal investigator
Pepperdine University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mivacunaLA in people with COVID-19 Pandemic, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: vaccination status among minors 12-17 years (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.