Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine Beliefs in Guatemala

April 5, 2022 updated by: Jamie Johnston, Stanford University

Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine

Prior evidence, including formative work supporting the development of this study, suggests there is widespread vaccine hesitancy among Indigenous communities in Guatemala, fueled by mistrust in the health system, lack of official information, and the circulation of myths and misinformation. We will test the effectiveness of a video-based social media campaign that provides a basic overview of the science behind COVID-19 vaccines and addresses prevalent myths and misinformation being shared in target communities. A series of animated videos will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish language, 2) K'iche' language, and 3) Kaqchikel language. Our primary outcomes are responses to two attitudinal questions collected via Facebook polling: 1) How safe do you think a COVID-19 vaccine is for people like you? (options: very safe, somewhat safe, barely safe, not safe, don't know); and 2) When you think of most people whose opinion you value, how much would they approve of people getting a COVID-19 vaccine? (options: definitely approve, mostly approve, somewhat approve, not at all approve, don't know). We will measure effects of the three treatment arms across Spanish speakers (including K'iche' and Kaqchikel speakers who also speak Spanish). We will also measure the effectiveness of K'iche vs. Spanish content among K'iche speakers and Kaqchikel vs. Spanish content for Kaqchikel speakers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Tecpán Guatemala, Guatemala
        • Wuqu' Kawoq - Maya Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The intervention will be delivered through the Facebook Ads platform. Intervention content will be promoted to Facebook Users throughout the entire country of Guatemala. K'iche' content will be targeted only in departments where the K'iche' language is primarily spoken. Kaqchikel content will be targeted only in departments where the Kaqchikel language is primarily spoken.

Exclusion Criteria:

  • Only adult Facebook users of age 18 will be included. Users under age 18 are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spanish language content
Social media campaign content with Spanish language voiceover
Other: COVID-19 vaccine social media campaign exposure
A series of animated video clips will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish, 2) K'iche', and 3) Kaqchikel languages. The videos are visually identical and follow the same audio script, translated into the three focal language. Local voiceover artists were used to record the scripts in the three languages. A control group that is not exposed to any of the social media campaign content will serve as active comparator to allow for comparison of outcomes with treatment arms.
Experimental: K'iche' language content
Social media campaign content with K'iche' language voiceover
Other: COVID-19 vaccine social media campaign exposure
A series of animated video clips will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish, 2) K'iche', and 3) Kaqchikel languages. The videos are visually identical and follow the same audio script, translated into the three focal language. Local voiceover artists were used to record the scripts in the three languages. A control group that is not exposed to any of the social media campaign content will serve as active comparator to allow for comparison of outcomes with treatment arms.
Experimental: Kaqchikel language content
Social media campaign content with Kaqchikel language voiceover
Other: COVID-19 vaccine social media campaign exposure
A series of animated video clips will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish, 2) K'iche', and 3) Kaqchikel languages. The videos are visually identical and follow the same audio script, translated into the three focal language. Local voiceover artists were used to record the scripts in the three languages. A control group that is not exposed to any of the social media campaign content will serve as active comparator to allow for comparison of outcomes with treatment arms.
Active Comparator: Control
A control group that is not exposed to any of the social media campaign content will serve as control to allow for comparison of outcomes with treatment arms.
Other: COVID-19 vaccine social media campaign exposure
A series of animated video clips will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish, 2) K'iche', and 3) Kaqchikel languages. The videos are visually identical and follow the same audio script, translated into the three focal language. Local voiceover artists were used to record the scripts in the three languages. A control group that is not exposed to any of the social media campaign content will serve as active comparator to allow for comparison of outcomes with treatment arms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beliefs about COVID-19 vaccine safety
Time Frame: 4 weeks
Our primary outcomes are responses to two attitudinal questions collected via Facebook polling. This outcome is response to the question: How safe do you think a COVID-19 vaccine is for people like you? (options: very safe, somewhat safe, barely safe, not safe, don't know).
4 weeks
Beliefs about COVID-19 vaccine acceptance among social network
Time Frame: 4 weeks
Our primary outcomes are responses to two attitudinal questions collected via Facebook polling. This outcome is response to the question: When you think of most people whose opinion you value, how much would they approve of people getting a COVID-19 vaccine? (options: definitely approve, mostly approve, somewhat approve, not at all approve, don't know).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco
Wuqu' Kawoq, Maya Health Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 63193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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