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Vaccine KnowledgeNCT06237374

Supporting CHWs as Vaccine Educators: Impact of a Digital Training and Chatbot Intervention on Vaccination in Kenya

A study testing Digital Vaccine Education Training & Patient-facing Chatbot Tool and Standard Training in people with Vaccine Knowledge and Vaccine Hesitancy, run by Stanford University at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study seeks to understand how to support community health workers (CHWs) to improve routine vaccination rates in high-need areas by testing a two-part intervention. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Digital Vaccine Education Training & Patient-facing Chatbot Tool and Standard Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
795 participants
Where
1 siteKenya
Study dates
16 Jan 2024to 1 Aug 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

  • CHWs identified by Lwala Community Health Alliance in study area
  • Patients with children in the household of eligible age for routine immunization

Who cannot join

  • Patients without children in the household of eligible age for routine immunization

Trial locations and contacts

1 site in 1 country.

Kenya1 site
  • Lwala Community Health Alliance

    Rongo

Other trials in Kenya

About this study

Official title: Supporting Community Health Workers as Vaccine Educators: Assessing the Impact of a Digital Health Training and Patient-facing Chatbot Intervention on Vaccination Rates in Kenya

This study seeks to understand how to support community health workers (CHWs) to improve routine vaccination rates in high-need areas by testing a two-part intervention. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot that CHWs can share with their patients. The chatbot is designed to answer patient questions about routine immunization. The intervention will be implemented in two sub-counties in Migori County Kenya (Awendo and Nyatike) that Lwala Community Health Alliance has identified as high need with respect to vaccine education. We hypothesize that the intervention will increase knowledge about routine immunization among CHWs and patients, increase vaccine acceptance, intent-to-vaccinate, and vaccination rates among patients in the treatment group.

Read the detailed description

Background:

Immunization programs in Sub-Saharan Africa have made progress in recent decades, yet coverage remains low overall for some childhood vaccines. Immunization is one of the most powerful and cost effective public health interventions. In addition to saving lives, vaccination can greatly reduce the burden of illness and disability from vaccine preventable diseases, and contribute to improving child health and welfare, as well as reducing hospitalization costs. Yet, globally, mistrust in childhood vaccinations increased during the COVID-19 pandemic. Vaccine hesitancy in Kenya is driven by multiple interrelated and interconnected factors, including mistrust in health systems and vaccine misinformation which has grown during the global COVID-19 pandemic.

Community Health Workers (CHWs) are vital to global vaccination efforts, both in the distribution and logistical support, but also in promoting vaccine acceptance. Now more than ever, CHWs face barriers as vaccine educators including the proliferation of misinformation, lack of reliable, up-to-date information, and limited training in effective communication.

Aim:

Researchers at Stanford University's Center for Health Education and the Lwala Community Health Alliance are partnering to investigate how to better support CHWs to improve routine vaccination rates in high-need areas by testing a two-part intervention. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education. The second part of the intervention is a patient-facing chatbot that is designed to provide patients with key information about routine immunizations with the intent of increasing patient knowledge about vaccines, vaccine acceptance, and vaccination rates.

Methods:

To test the effectiveness of training and equipping CHWs with the digital training and chatbot tool, study researchers will conduct a cluster randomized trial in the two focal subcounties in Migori County (Awendo and Nyatike) that the Lwala Community Health Alliance has identified as high need with respect to vaccine education. Lwala survey data suggest that between 20-25 percent of children under 5 years have not received routine immunizations in these two sub-counties. Early anecdotal data has shown that there are additional barriers and vaccine hesitancy concerns with the rollout of the new malaria vaccine.

CHWs in the focal subcounties are organized into regional administrative units known as Community Health Units (CHUs). Training is provided at regularly scheduled CHU meetings attended by CHWs on a regular basis. The research team will randomize CHUs (Awendo/ 31 CHUs and Nyatike/ 48 CHUs) into a treatment arm in which CHWs receive the training and chatbot tool and a control arm in which CHWs receive neither. The CHWs will be blinded to treatment assignment and informed that they are taking part in a study to understand the CHW experiences and their communication with patients. Randomization will be stratified by geographic units (wards) and whether a health facility is available in the ward.

The participants in the treatment group will receive the intervention at the start of the study, while the participants in the control group will receive upon conclusion of the study, which will allow for the comparison of knowledge, beliefs and vaccination rates with a group that is controlled for bias introduced by time. The duration of the study for participants will be roughly four months, which will allow CHWs ample time to introduce the chatbot to eligible patients and provide patients with time to use the chatbot to inform their vaccine decision making.

Intervention:

The intervention is being developed by the Stanford Center for Health Education Digital Medic Initiative in collaboration with Lwala Community Health Alliance. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot designed to provide key information about routine immunization that CHWs can share with their patients through the social media and messenger application, WhatsApp.

The Stanford team has led the production of the video content, job aids, and chatbot design. The Lwala team has partnered in intervention design and development at all stages including script writing, piloting, and checking for relevance and resonance of educational content. The video content addresses reasons to vaccinate, vaccine misperceptions, side effects, and other barriers to improve childhood vaccination uptake. The video content is complemented by a set of infographic job aids for CHWs to share with their patients to encourage childhood immunization uptake. Content will be available in English and Dholuo.

Data collection:

Treatment and control CHWs will complete a baseline and endline survey administered at the same time. The baseline survey will include demographic questions and questions about CHWs' work experience including their perceptions of vaccine safety and effectiveness and preparedness to educate patients about complex health topics including childhood immunization. The endline survey will include a knowledge assessment drawn from the training content, as well as measures of CHW vaccine acceptance and preparedness to educate patients about childhood immunization. A subsample of patients will be surveyed at endline from both the treatment and control groups. The patient survey will include demographic questions and questions about patients' knowledge and beliefs about childhood immunization, intent-to-vaccinate and vaccination status among household members.

Data Analysis:

The primary analysis will be based on intention-to-treat at the CHU unit. The analysis will include randomization strata fixed effects and control for baseline covariates to improve precision of estimates.

Being tested
Digital Vaccine Education Training & Patient-facing Chatbot Tool, Standard Training
Medical subject headings
Vaccination Hesitancy, Vaccination Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Vaccine Education Training & Patient-facing Chatbot ToolBehavioural

    The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot designed to provide key information about routine immunization that CHWs can share with their patients through the social media and messenger application, WhatsApp.

  • Standard TrainingBehavioural

    All CHWs in the study will receive the standard CHW training that is provided on an ongoing basis by Lwala Community Health Alliance.

Study groups in NCT06237374
Study groupRoleWhat they receive
TreatmentExperimentalCommunity health workers (CHWs) will receive the intervention training videos, job aids and chatbot tool to share with patients via WhatsApp in addition to standard CHW training provided by Lwala Community Health Alliance.
Receives: Behavioral: Digital Vaccine Education Training & Patient-facing Chatbot Tool; Behavioral: Standard Training
ControlActive comparatorParticipants in the control group will receive standard community health worker (CHW) training provided by Lwala Community Health Alliance.
Receives: Behavioral: Standard Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CHW vaccine knowledge

    Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training

    Measured: Collected after roughly 1 month of exposure to the training content

  2. CHW vaccine beliefs

    Set of 5 Likert scale questions about beliefs about routine childhood vaccines regarding 1) the safety of childhood vaccines, 2) the effectiveness of childhood vaccines, 3) whether children should receive the new Malaria vaccine, 4) whether children receive too many vaccines, and 5) whether vaccination is compatible with one's personal beliefs.

    Measured: Collected after roughly 1 month of exposure to the training content

  3. CHW vaccine education preparedness

    Set of 5 Likert scale questions about preparedness to educate patients about routine childhood vaccines including 1) preparedness to answer patient questions, 2) preparedness to explain complex health topics including immunization to patients, 3) adequate access to information about vaccines and the diseases they prevent, 4) preparedness to explain the need for so many childhood vaccines, and 5) preparedness to alleviate patients' fears about vaccination.

    Measured: Collected after roughly 1 month of exposure to the training content

  4. Patient vaccine knowledge

    Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training

    Measured: Collected roughly 4-6 months from CHW first exposure to the training content

  5. Patient vaccine beliefs

    Set of 5 Likert scale questions about beliefs about routine childhood vaccines regarding 1) the safety of childhood vaccines, 2) the effectiveness of childhood vaccines, 3) whether children should receive the new Malaria vaccine, 4) whether children receive too many vaccines, and 5) whether vaccination is compatible with one's personal beliefs.

    Measured: Collected roughly 4-6 months from CHW first exposure to the training content

  6. Patient vaccination uptake

    Vaccination uptake among patients of treatment CHWs measured by CHW records, patient self reports, and administrative health records (where available)

    Measured: Collected roughly 6 months from CHW first exposure to the training content

Secondary outcomes (1)
  1. CHW perceptions of patient vaccine beliefs

    Set of 6 Likert scale questions posted to CHWs about the beliefs of their patients including whether their patients 1) believe vaccines are safe, 2) believe vaccines are important, 3) know when you bring children to clinic to receive vaccinations, 4) believe that all doses are important for children to receive, 5) are fearful of adverse vaccine side effects, and 6) are fearful of long-term impact of vaccines on their children.

    Measured: Collected after roughly 1 month of exposure to the training content

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start16 Jan 2024
  3. Primary completion1 Mar 2024
  4. Study completion1 Aug 2024 (estimated)

Resources

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
This is a cluster randomized trial with baseline covariate adjustment and stratification. The randomization unit is the Community Health Unit (CHU), the administrative unit in which community health workers (CHWs) are organized in the study region. The randomization will be stratified by geographic unit (wards) and whether a health facility is located in the ward. The following baseline characteristics will be measured and adjusted for in the main analysis of primary outcomes to increase statistical efficiency: 1) age, 2) gender, 3) language, 4) years of work experience, 5) vaccine beliefs, and 6) self-reported preparedness to educate patients about vaccination.
Masking
Single blind
Who is masked
Participant
Enrolment
795 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06237374
Sponsor's protocol ID
69793
Status last verified
Apr 2024
First submitted
24 Jan 2024
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Digital Vaccine Education Training & Patient-facing Chatbot Tool and Standard Training in people with Vaccine Knowledge and Vaccine Hesitancy, run by Stanford University at 1 site in Kenya.

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 2 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 Kenya. 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?

Results are not available in the source record.

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?

CHW vaccine knowledge (time frame: Collected after roughly 1 month of exposure to the training content). The study lists 6 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 16 Apr 2024.

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