NCT05252936

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

21 days

First QC Date

February 21, 2022

Last Update Submit

April 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    4 weeks

Study Arms (4)

Spanish language content

EXPERIMENTAL

Social media campaign content with Spanish language voiceover

Other: COVID-19 vaccine social media campaign exposure

K'iche' language content

EXPERIMENTAL

Social media campaign content with K'iche' language voiceover

Other: COVID-19 vaccine social media campaign exposure

Kaqchikel language content

EXPERIMENTAL

Social media campaign content with Kaqchikel language voiceover

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.

Other: COVID-19 vaccine social media campaign exposure

Interventions

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.

ControlK'iche' language contentKaqchikel language contentSpanish language content

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuqu' Kawoq - Maya Health Alliance

Tecpán Guatemala, Guatemala

Location

MeSH Terms

Conditions

Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

February 21, 2022

First Posted

February 23, 2022

Study Start

March 14, 2022

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations