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CompletedNCT06186206CLAVEUpdated Mar 20, 2025

Culturally and Linguistically Appropriate Vaccine Education

An interventional study of Social media interventions for vaccine uptake in Vaccine Hesitancy, sponsored by University of California, San Francisco. Completed at 1 site in Guatemala. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to test the effectiveness of culturally tailored social media campaigns and WhatsApp-based vaccine training for healthcare workers in increasing childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala.

Main Research Questions:

  • Does a culturally tailored social media campaign, deployed via Facebook and geographically targeting randomly assigned communities, increase childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala?
  • Does WhatsApp-based vaccine training for community healthcare workers increase vaccine uptake in these communities?

Participants in this study will be involved in the following tasks:

Community Healthcare Worker WhatsApp Training: Community healthcare workers will participate in WhatsApp training sessions to enhance their knowledge and skills related to vaccine education and communication.

Pre-Post Surveys: Surveys will be collected from individuals who are caretakers of children under 5 recruited from local health facilities. A total of 600 people will participate in the surveys (200 from each study arm and 200 pre-intervention). Surveys will be conducted in Spanish, K'iche', and Kaqchikel languages to compare vaccination uptake, hesitancy, and barriers/facilitators of vaccination.

Researchers will compare the groups receiving the social media campaign and WhatsApp training to those with no intervention to determine the effects on childhood routine and HPV vaccine confidence and uptake in indigenous rural communities in Guatemala.

Read the detailed description

This clinical trial seeks to address the challenge of improving childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala. The study is designed with three distinct study arms to assess the effectiveness of culturally tailored interventions. The interventions include a social media campaign delivered via Facebook, as well as WhatsApp-based vaccine training for community healthcare workers. The ultimate goal is to determine whether these interventions have a positive impact on vaccination rates and confidence in the target communities.

The clinical trial is organized into three arms. The first arm comprises four communities that will receive only the culturally tailored social media campaign, designed to increase childhood routine and HPV vaccine confidence and uptake. This campaign is specifically targeted at these communities through geographic targeting on Facebook. The second arm includes four communities that will receive both the social media campaign and WhatsApp-based vaccine training for community healthcare workers. Finally, the third arm, serving as the control group, consists of four communities where there will be no intervention.

The primary research questions guiding this clinical trial are as follows:

  1. Does the culturally tailored social media campaign, deployed via Facebook and geographically targeting randomly assigned communities, increase childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala?
  2. Does WhatsApp-based vaccine training for community healthcare workers increase vaccine uptake in these communities?

In the second arm of the study, community healthcare workers will actively participate in WhatsApp training sessions. These sessions are designed to enhance their knowledge and communication skills related to vaccine education and advocacy. They will be encouraged to use the WhatsApp platform to engage in discussions, ask questions, and support one another in their efforts to effectively communicate the importance of childhood vaccinations with their patients.

Additionally, the clinical trial includes the collection of pre-post surveys from individuals who are caretakers of children under 5 years old. These individuals will be recruited from local health facilities, with a total of 600 participants across the three arms (200 from each intervention group and 200 from the pre-intervention phase). Surveys will be conducted in Spanish, K'iche', and Kaqchikel languages, allowing for a comprehensive assessment of vaccination uptake, hesitancy, and barriers/facilitators of vaccination.

To evaluate the effectiveness of the interventions, researchers will conduct a thorough analysis, comparing the three study arms. The analysis will involve several components:

  • Comparing the first arm, which receives social media messaging only, to the control group to assess the impact of the social media campaign.
  • Comparing the second arm, receiving both social media messaging and healthcare worker WhatsApp training, to the control group to determine the combined impact of these interventions.
  • Lastly, comparing the two intervention groups to each other to identify any differences in effectiveness between the interventions.

Statistical methods, including regression analysis and interrupted time series analysis, will be employed to assess the impact of the interventions on the primary outcomes, which include childhood routine and HPV vaccine confidence and uptake.

In conclusion, this clinical trial represents a rigorous effort to address vaccination challenges in indigenous rural communities in Guatemala. By leveraging social media campaigns and healthcare worker training via WhatsApp, the study aims to improve vaccine confidence and uptake, ultimately contributing to better public health outcomes in these underserved populations.

02

Conditions studied

  • Vaccine Hesitancy

Keywords

  • Vaccination
  • Indigenous Communities
  • Social Media Campaign
  • Guatemala
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • speaks a local language,
  • live in the area,
  • over age 18 and
  • cares for a child 5 years or younger

Exclusion criteria

Exclusion Criteria:

  • Not an adult,
  • not on social media
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (actual)

Study arms

  • Experimental
    Social Media Messaging Only

    In this arm of the clinical trial, four selected communities will receive a culturally tailored social media campaign designed to increase childhood routine and HPV vaccine confidence and uptake. The campaign will be deployed via Facebook and will geographically target these communities. This arm serves as the first intervention group.

    Behavioral: Social media interventions for vaccine uptake

  • Experimental
    Social Media and Health Worker WhatsApp

    In this arm, another set of four communities will receive both the culturally tailored social media campaign (deployed via Facebook) and WhatsApp-based vaccine training for community healthcare workers. This arm serves as the second intervention group.

    Behavioral: Social media interventions for vaccine uptake

  • No intervention
    No Intervention (Control)

Interventions

  • BehavioralSocial media interventions for vaccine uptake

    Culturally Tailored Social Media Campaign: 4 communities receive a culturally tailored social media campaign via Facebook, focusing on geographical targeting. Content aligns with indigenous cultural norms and values, featuring educational materials, testimonials, and messaging addressing vaccine misconceptions on childhood routine and HPV vaccinations' importance and safety. WhatsApp-Based Vaccine Training for CHW: 4 communities receive both the culturally tailored social media campaign and WhatsApp-based vaccine training for CHWs. Interactive training allows CHWs to engage in discussions, seek guidance, and enhance their ability to communicate effectively. This component targets vaccine hesitancy and boosts vaccine uptake rates.

06

What researchers measure

Primary outcomes

  1. Vaccination of children < 5 years

    Health facility clinic data about vaccinations for key under 5 years of age vaccinations and HPV. We will measure overall coverage of routine childhood vaccines (defined as having completed all recommended vaccines by age), as well as coverage by individual vaccine type. Caregiver report of childhood vaccinations in the last 3 months, collected via in person survey (yes/no responses to questions about specific recent vaccines given the age of the child)

    Time frame: 6 months

  2. Hesitancy for vaccination

    Caregiver report of childhood vaccination hesitancy, collected via in person survey. Collected using the Vaccine Hesitancy Scale, which has been validated in rural Guatemala for childhood vaccination

    Time frame: 2 months after intervention

Secondary outcomes

  1. Vaccine knowledge

    Increase in knowledge of childhood and HPV vaccines

    Time frame: 2 months after intervention

07

Study locations

1 site
  • Maya Health Alliance | Wuqu' Kawoq
    Tecpán Guatemala, Chimaltenango, Guatemala
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06186206
Lead sponsor
University of California, San Francisco
Collaborators
Stanford University, Wuqu' Kawoq, Maya Health Alliance
Responsible party
Sponsor
First posted
Dec 29, 2023
Start date
Jan 5, 2024
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024
Last update
Mar 20, 2025

Study contacts

Nadia Diamond-Smith, PhD, MS
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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