Vaccination RefusalNCT05252936
Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine Beliefs in Guatemala
A study testing COVID-19 vaccine social media campaign exposure in people with Vaccination Refusal, run by Stanford University at 1 site in Guatemala.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- COVID-19 vaccine social media campaign exposure
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteGuatemala
- Study dates
- 14 Mar 2022to 4 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Only adult Facebook users of age 18 will be included. Users under age 18 are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vaccination Refusal
- Being tested
- COVID-19 vaccine social media campaign exposure
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine social media campaign exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Spanish language content | Experimental | Social media campaign content with Spanish language voiceover Receives: Other: COVID-19 vaccine social media campaign exposure |
| K'iche' language content | Experimental | Social media campaign content with K'iche' language voiceover Receives: Other: COVID-19 vaccine social media campaign exposure |
| Kaqchikel language content | Experimental | Social media campaign content with Kaqchikel language voiceover Receives: Other: COVID-19 vaccine social media campaign exposure |
| Control | Active comparator | 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. Receives: Other: COVID-19 vaccine social media campaign exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beliefs about COVID-19 vaccine safety
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).
Measured: 4 weeks
Beliefs about COVID-19 vaccine acceptance among social network
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start14 Mar 2022
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, University of California, San Francisco
- Responsible party
- Principal investigator, Jamie Johnston, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252936
- Sponsor's protocol ID
- 63193
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05252936
- Acronym / sponsor ID
- 63193
- Conditions
- Vaccination Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, University of California, San Francisco
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 23 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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. 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.
| Arm | Type | Receives |
|---|---|---|
| Spanish language content | Experimental | Other: COVID-19 vaccine social media campaign exposureSocial media campaign content with Spanish language voiceover |
| K'iche' language content | Experimental | Other: COVID-19 vaccine social media campaign exposureSocial media campaign content with K'iche' language voiceover |
| Kaqchikel language content | Experimental | Other: COVID-19 vaccine social media campaign exposureSocial media campaign content with Kaqchikel language voiceover |
| Control | Active comparator | Other: COVID-19 vaccine social media campaign exposureA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Only adult Facebook users of age 18 will be included. Users under age 18 are excluded.
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 |
|---|---|---|
| COVID-19 vaccine social media campaign exposureA 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. | Other | Control, K'iche' language content, Kaqchikel language content, Spanish language content |
Primary outcome
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).
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).
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 7 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 vaccine social media campaign exposure in people with Vaccination Refusal, run by Stanford University at 1 site in Guatemala.
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 1 inclusion and 1 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. 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?
Beliefs about COVID-19 vaccine safety (time frame: 4 weeks). 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 7 Apr 2022.