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.
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
- Conditions the study is for
- Vaccine Knowledge, Vaccine Hesitancy, Vaccine Refusal
- What is being tested?
- Digital Vaccine Education Training & Patient-facing Chatbot Tool and Standard Training
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Vaccine Knowledge, Vaccine Hesitancy, Vaccine Refusal
- 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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Community 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 |
| Control | Active comparator | Participants 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.
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
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
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
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
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
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)
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.
- First posted1 Feb 2024
- Study start16 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine KnowledgeStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Johnston, Stanford University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06237374
- Acronym / sponsor ID
- 69793
- Conditions
- Vaccine Knowledge, Vaccine Hesitancy, Vaccine Refusal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 795 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Digital Vaccine Education Training & Patient-facing Chatbot Tool, Behavioral: Standard TrainingCommunity 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. |
| Control | Active comparator | Behavioral: Standard TrainingParticipants in the control group will receive standard community health worker (CHW) training provided by Lwala Community Health Alliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CHWs identified by Lwala Community Health Alliance in study area
- Patients with children in the household of eligible age for routine immunization
Key exclusion criteria (1 listed)
- Patients without children in the household of eligible age for routine immunization
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 |
|---|---|---|
| Digital Vaccine Education Training & Patient-facing Chatbot ToolThe 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. | Behavioural | Treatment |
| Standard TrainingAll CHWs in the study will receive the standard CHW training that is provided on an ongoing basis by Lwala Community Health Alliance. | Behavioural | Control, Treatment |
Primary outcome
CHW vaccine knowledge
Time frame: Collected after roughly 1 month of exposure to the training content
Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training
CHW vaccine beliefs
Time frame: Collected after roughly 1 month of exposure to the training content
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.
CHW vaccine education preparedness
Time frame: Collected after roughly 1 month of exposure to the training content
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.
Patient vaccine knowledge
Time frame: Collected roughly 4-6 months from CHW first exposure to the training content
Knowledge about routine childhood vaccines based on a set of 15 knowledge questions draw directly from the digital training
Patient vaccine beliefs
Time frame: Collected roughly 4-6 months from CHW first exposure to the training content
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.
Patient vaccination uptake
Time frame: Collected roughly 6 months from CHW first exposure to the training content
Vaccination uptake among patients of treatment CHWs measured by CHW records, patient self reports, and administrative health records (where available)
1 secondary outcome
CHW perceptions of patient vaccine beliefs
Time frame: Collected after roughly 1 month of exposure to the training content
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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 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.