Vaccine HesitancyCLAVENCT06186206
Culturally and Linguistically Appropriate Vaccine Education
A study testing Social media interventions for vaccine uptake in people with Vaccine Hesitancy, run by University of California, San Francisco at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Social media interventions for vaccine uptake
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteGuatemala
- Study dates
- 5 Jan 2024to 15 Mar 2024
- 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
- speaks a local language,
- live in the area,
- over age 18 and
- cares for a child 5 years or younger
Who cannot join
- Not an adult,
- not on social media
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
Maya Health Alliance | Wuqu' Kawoq
Tecpán Guatemala, Departamento de Chimaltenango
About this study
Official title: Culturally and Linguistically Appropriate Vaccine Education (CLAVE): an Evaluation of Social Media Vaccine Communication Messages in Rural Guatemala
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:
Read more
- 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:
- 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?
- 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.
- Conditions
- Vaccine Hesitancy
- Being tested
- Social media interventions for vaccine uptake
- Keywords
- Vaccination, Indigenous Communities, Social Media Campaign, Guatemala
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social media interventions for vaccine uptakeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Media Messaging Only | Experimental | 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. Receives: Behavioral: Social media interventions for vaccine uptake |
| Social Media and Health Worker WhatsApp | Experimental | 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. Receives: Behavioral: Social media interventions for vaccine uptake |
| No Intervention (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
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
Measured: 2 months after intervention
Secondary outcomes (1)
Vaccine knowledge
Increase in knowledge of childhood and HPV vaccines
Measured: 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start5 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Wuqu' Kawoq, Maya Health Alliance
- Responsible party
- Sponsor
- Investigators
- Nadia Diamond-Smith, PhD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186206
- Sponsor's protocol ID
- 00123120
- Acronym
- CLAVE
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnston JS, Abascal Miguel L, Gaitan Barrillas R, Lopez E, Coxaj J, Sotz Mux MS, Suchdev PS, Monzon Fuentes JC, Pardo E, Johnston S, Skinner NA, Kraemer Diaz A, Diamond-Smith N, Ward VC. Culturally and linguistically appropriate vaccine education (CLAVE) for Indigenous communities: design and implementation study of a community-based approach to digital vaccine education in the Central Highlands of Guatemala. Int J Equity Health. 2026 Apr 14;25(1):113. doi: 10.1186/s12939-026-02836-9.
PubMed 41981637
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally and Linguistically Appropriate Vaccine Education (CLAVE): an Evaluation of Social Media Vaccine Communication Messages in Rural Guatemala
- ClinicalTrials.gov ID
- NCT06186206
- Acronym / sponsor ID
- CLAVE / 00123120
- Conditions
- Vaccine Hesitancy
- Keywords
- Vaccination, Indigenous Communities, Social Media Campaign, Guatemala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, Wuqu' Kawoq, Maya Health Alliance
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 29 Dec 2023 (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 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.
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:
- 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?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Media Messaging Only | Experimental | Behavioral: Social media interventions for vaccine uptakeIn 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. |
| Social Media and Health Worker WhatsApp | Experimental | Behavioral: Social media interventions for vaccine uptakeIn 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. |
| No Intervention (Control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- speaks a local language,
- live in the area,
- over age 18 and
- cares for a child 5 years or younger
Key exclusion criteria (2 listed)
- Not an adult,
- not on social media
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 |
|---|---|---|
| Social media interventions for vaccine uptakeCulturally 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. | Behavioural | Social Media Messaging Only, Social Media and Health Worker WhatsApp |
Primary outcome
Vaccination of children < 5 years
Time frame: 6 months
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)
Hesitancy for vaccination
Time frame: 2 months after intervention
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
1 secondary outcome
Vaccine knowledge
Time frame: 2 months after intervention
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 20 Mar 2025.
- Derived from this study: PubMed 41981637Johnston JS, Abascal Miguel L, Gaitan Barrillas R, Lopez E, Coxaj J, Sotz Mux MS, Suchdev PS, Monzon Fuentes JC, Pardo E, Johnston S, Skinner NA, Kraemer Diaz A, Diamond-Smith N, Ward VC. Culturally and linguistically appropriate vaccine education (CLAVE) for Indigenous communities: design and implementation study of a community-based approach to digital vaccine education in the Central Highlands of Guatemala. Int J Equity Health. 2026 Apr 14;25(1):113. doi: 10.1186/s12939-026-02836-9.
- Individual participant dataSharing planned: No
Related trials for Vaccine Hesitancy
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
Acute Coronary Syndrome, Heart Failure
Not yet recruiting
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
Vaccine Hesitancy, Vaccine Acceptance
Active, not recruiting
Communication Strategies to Increase HPV Vaccinations
Papilloma Viral Infection, Vaccine Hesitancy
Not yet recruiting
Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy
HPV Vaccine
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.
Nadia Diamond-Smith, PhD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social media interventions for vaccine uptake in people with Vaccine Hesitancy, run by University of California, San Francisco 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 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 20 Mar 2025. 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?
Vaccination of children < 5 years (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT06186206, which also lists 1 linked publication.
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 20 Mar 2025.