MeaslesNCT06218368
A Tool Kit to Improve Vaccine Confidence in the Philippines
A study testing Educational toolkit on MMR and polio vaccination in people with Measles and Polio, run by University of Toronto at 1 site in Philippines.
Trial summary
This cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Measles, Polio, Vaccination Hesitancy
- What is being tested?
- Educational toolkit on MMR and polio vaccination
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,400 participants
- Where
- 1 sitePhilippines
- Study dates
- 31 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals reside in the participating communities where ICM recruits for the Transform Program.
- Individuals meet the criteria and definition of ultra-poor based on the ICM's screening*.
- Individuals give oral informed consent to participate in the health education sessions which includes the delivery of our toolkit. There must be 30 eligible participants before a community will be approved to participate in the ICM Transform Program.
- All participating communities of the ICM Soap Opera trial who provided consents to health education sessions will be eligible to participate in the vaccine confidence trial. Participants will be screened using a poverty score card, loosely based on the Progress out of Poverty Index (PPI) developed for the Philippines (Innovations for Poverty Action, 2014) and self-reported household income. Participants in households that meet the definition of ultra-poor by income (< 22 Philippine pesos per person per day) are prioritized to be recruited for the Transform Program.
Who cannot join
- Individuals who refuse to participate will not be included in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial to Evaluate the Effectiveness of an Educational Toolkit Among Poor Communities in Improving Vaccination Confidence in the Philippines
This cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. The toolkit contains four aspects: an introduction to MMR and polio vaccines, vaccine safety and efficacy, vaccination guidelines (including schedules and locations), and debunking myths and misconceptions. Presented as a 10-minute video and followed by reminder messages from health educators, the toolkit was developed in collaboration with International Care Ministries (ICM) health educators and translated into local dialects.
Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future. A total of 180 communities participating in the Transform program will be randomly assigned to one of the two arms. In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures.
The effectiveness of the toolkit will be evaluated by 1) the rate of MMR and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods, and cost-effectiveness of the intervention will be assessed.
Read the detailed description
This cluster randomized controlled trial (RCT) aims to assess the feasibility and efficacy of an educational toolkit co-developed with local stakeholders to enhance confidence in measles, mumps, rubella (MMR) and polio vaccines in the Philippines. The toolkit contains information and messages about the following four aspects of MMR and polio vaccines: 1) comprehensive introduction of MMR and polio; 2) vaccines safety and efficacy; 3) MMR and polio vaccination guidelines with vaccination schedules and locations; and 4) myths and misconceptions. The educational toolkit will be presented using a 10-minute translated video converted from PowerPoint slides in one session. Reminder messages regarding vaccination will then be delivered in following sessions by health educators. The educational toolkit, as well as the adapted PowerPoint slide deck and accompanying script, was collaboratively developed with health educators from International Care Ministries (ICM). Professional translators have translated the finalized English version of the slide deck and script into the local dialects. Subsequently, ICM produced a video featuring a health worker presenting the toolkit, synchronized with the voiceover and PowerPoint slides.
Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video is entitled "First Light" and is produced by ICM's own internal media team. It includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this cluster RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future, investments on children's education, social capital, health, hope, and economic outcomes. A 'cluster' is defined as a community participating in the Transform Program. Each community consists of 30 participants, forming the basic unit for our intervention and analysis. Randomization will be performed at the community level by the ICM, and the 180 communities participating in the Transform program will be randomly assigned to one of the two arms (intervention and control). In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures.
The effectiveness of the toolkit will be evaluated by 1) the rate of measles, mumps, rubella (MMR) and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Differences in the two outcomes will be compared between the intervention and control arms using appropriate statistical analysis. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods. The investigators will purposively select 30 end-users to conduct semi-structured interviews, which aim to understand the accuracy and appropriateness of the toolkit content, user perception of the toolkit's relevance, and overall satisfaction with the toolkit. Finally, the investigators will conduct a cost-effectiveness analysis to compare the cost, participants' attitude towards MMR and polio vaccines, and the immunization rates of children in the immediate families of participants associated with our intervention versus no intervention over the entire intervention time horizon.
- Conditions
- Measles, Polio, Vaccination Hesitancy
- Being tested
- Educational toolkit on MMR and polio vaccination
- Medical subject headings
- Measles, Poliomyelitis, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational toolkit on MMR and polio vaccinationBehavioural
The educational video about vaccines was adapted from a health educational toolkit that aims to promote community confidence in vaccines in the ultra-poor Philippine households. This toolkit contains persuasive messaging on vaccination guidelines, vaccines safety and efficacy, and myths and misconceptions of MMR and polio vaccines. Participants in the intervention arm will receive our educational video about MMR and polio vaccines. Additionally, health educators from ICM will teach the participants to understand their vaccination cards and orally remind them to have their children vaccinated at each week's Transform Program session from week 12 until week 15. After the end of the Transform Program, about 40-50% of the participants in the intervention arm will attend another community-based program run by ICM called the Savings Groups, where the participants will receive weekly reminding messages about MMR and polio vaccination in their group meetings for three months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will receive our vaccine toolkit intervention, which includes two main components: 1) our educational toolkit on MMR and polio vaccination in the form of a video, which will be introduced and presented to the participants from Week 12 to Week 15 of the Transform program, 2) reminding messages regarding vaccination, which will be delivered following the video session and embedded in Saving Groups program run in the communities. Additionally, participants in the intervention arm will also receive a series of 15 soap opera videos, one for each week, to complement the 15-week Transform Program's education session, which is the core intervention of the Soap Opera Trial developed and run by the ICM. Receives: Behavioral: Educational toolkit on MMR and polio vaccination |
| Control | No intervention | In the control group, participants will attend the standard 15-week Transform program, with education sessions delivered through traditional lectures by health educators from ICM on the topics of income creation, education, food security, and resilience. Our educational toolkit of MMR and polio vaccination will not be provided and there will be no specific reminders or discussions regarding MMR and polio vaccinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-dose measles-containing-vaccine (MCV) coverage rate
The rate of first-dose measles-containing-vaccine (MCV) vaccination among children aged 12 months among the family of participants
Measured: 6 months after intervention
Secondary outcomes (3)
Two-dose MCV coverage rate
Two-dose MCV coverage rate among participants' children over 24-month old
Measured: 6 months after intervention
Polio vaccination rate
The rate of polio vaccination among children over 14 weeks old who have received at least three doses of polio vaccines (IPV or OPV) among the family of participants
Measured: 6 months after intervention
Mean knowledge score
Mean knowledge score towards measles and polio vaccines among the participants, measured by a 10-item questionnaire developed by the investigators
Measured: 6 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 posted23 Jan 2024
- Study start31 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 MeaslesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- International Care Ministries, the Philippines
- Responsible party
- Principal investigator, Xiaolin Wei, University of Toronto
- Investigators
- Xiaolin Wei, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218368
- Sponsor's protocol ID
- PRCT2021710
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.
Publications
Wu S, Dong Q, Zhang Z, Pang S, Thorpe K, Kelly M, Haldane V, Lau L, Wei X. Effectiveness of an Education Toolkit Delivered by Soap Operas Among Communities Living in Extreme Poverty in Improving Vaccination Confidence in the Philippines: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 30;14:e77022. doi: 10.2196/77022.
PubMed 41166704
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial to Evaluate the Effectiveness of an Educational Toolkit Among Poor Communities in Improving Vaccination Confidence in the Philippines
- ClinicalTrials.gov ID
- NCT06218368
- Acronym / sponsor ID
- PRCT2021710
- Conditions
- Measles, Polio, Vaccination Hesitancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- International Care Ministries, the Philippines
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Jan 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 cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. The toolkit contains four aspects: an introduction to MMR and polio vaccines, vaccine safety and efficacy, vaccination guidelines (including schedules and locations), and debunking myths and misconceptions. Presented as a 10-minute video and followed by reminder messages from health educators, the toolkit was developed in collaboration with International Care Ministries (ICM) health educators and translated into local dialects.
Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future. A total of 180 communities participating in the Transform program will be randomly assigned to one of the two arms. In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures.
The effectiveness of the toolkit will be evaluated by 1) the rate of MMR and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods, and cost-effectiveness of the intervention will be assessed.
Detailed description
This cluster randomized controlled trial (RCT) aims to assess the feasibility and efficacy of an educational toolkit co-developed with local stakeholders to enhance confidence in measles, mumps, rubella (MMR) and polio vaccines in the Philippines. The toolkit contains information and messages about the following four aspects of MMR and polio vaccines: 1) comprehensive introduction of MMR and polio; 2) vaccines safety and efficacy; 3) MMR and polio vaccination guidelines with vaccination schedules and locations; and 4) myths and misconceptions. The educational toolkit will be presented using a 10-minute translated video converted from PowerPoint slides in one session. Reminder messages regarding vaccination will then be delivered in following sessions by health educators. The educational toolkit, as well as the adapted PowerPoint slide deck and accompanying script, was collaboratively developed with health educators from International Care Ministries (ICM). Professional translators have translated the finalized English version of the slide deck and script into the local dialects. Subsequently, ICM produced a video featuring a health worker presenting the toolkit, synchronized with the voiceover and PowerPoint slides.
Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video is entitled "First Light" and is produced by ICM's own internal media team. It includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this cluster RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future, investments on children's education, social capital, health, hope, and economic outcomes. A 'cluster' is defined as a community participating in the Transform Program. Each community consists of 30 participants, forming the basic unit for our intervention and analysis. Randomization will be performed at the community level by the ICM, and the 180 communities participating in the Transform program will be randomly assigned to one of the two arms (intervention and control). In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures.
The effectiveness of the toolkit will be evaluated by 1) the rate of measles, mumps, rubella (MMR) and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Differences in the two outcomes will be compared between the intervention and control arms using appropriate statistical analysis. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods. The investigators will purposively select 30 end-users to conduct semi-structured interviews, which aim to understand the accuracy and appropriateness of the toolkit content, user perception of the toolkit's relevance, and overall satisfaction with the toolkit. Finally, the investigators will conduct a cost-effectiveness analysis to compare the cost, participants' attitude towards MMR and polio vaccines, and the immunization rates of children in the immediate families of participants associated with our intervention versus no intervention over the entire intervention time horizon.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational toolkit on MMR and polio vaccinationParticipants in the intervention arm will receive our vaccine toolkit intervention, which includes two main components: 1) our educational toolkit on MMR and polio vaccination in the form of a video, which will be introduced and presented to the participants from Week 12 to Week 15 of the Transform program, 2) reminding messages regarding vaccination, which will be delivered following the video session and embedded in Saving Groups program run in the communities. Additionally, participants in the intervention arm will also receive a series of 15 soap opera videos, one for each week, to complement the 15-week Transform Program's education session, which is the core intervention of the Soap Opera Trial developed and run by the ICM. |
| Control | No intervention | –In the control group, participants will attend the standard 15-week Transform program, with education sessions delivered through traditional lectures by health educators from ICM on the topics of income creation, education, food security, and resilience. Our educational toolkit of MMR and polio vaccination will not be provided and there will be no specific reminders or discussions regarding MMR and polio vaccinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals reside in the participating communities where ICM recruits for the Transform Program.
- Individuals meet the criteria and definition of ultra-poor based on the ICM's screening*.
- Individuals give oral informed consent to participate in the health education sessions which includes the delivery of our toolkit. There must be 30 eligible participants before a community will be approved to participate in the ICM Transform Program.
Key exclusion criteria (1 listed)
- Individuals who refuse to participate will not be included in the trial.
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 |
|---|---|---|
| Educational toolkit on MMR and polio vaccinationThe educational video about vaccines was adapted from a health educational toolkit that aims to promote community confidence in vaccines in the ultra-poor Philippine households. This toolkit contains persuasive messaging on vaccination guidelines, vaccines safety and efficacy, and myths and misconceptions of MMR and polio vaccines. Participants in the intervention arm will receive our educational video about MMR and polio vaccines. Additionally, health educators from ICM will teach the participants to understand their vaccination cards and orally remind them to have their children vaccinated at each week's Transform Program session from week 12 until week 15. After the end of the Transform Program, about 40-50% of the participants in the intervention arm will attend another community-based program run by ICM called the Savings Groups, where the participants will receive weekly reminding messages about MMR and polio vaccination in their group meetings for three months. | Behavioural | Intervention |
Primary outcome
First-dose measles-containing-vaccine (MCV) coverage rate
Time frame: 6 months after intervention
The rate of first-dose measles-containing-vaccine (MCV) vaccination among children aged 12 months among the family of participants
3 secondary outcomes
Two-dose MCV coverage rate
Time frame: 6 months after intervention
Polio vaccination rate
Time frame: 6 months after intervention
Mean knowledge score
Time frame: 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41166704Wu S, Dong Q, Zhang Z, Pang S, Thorpe K, Kelly M, Haldane V, Lau L, Wei X. Effectiveness of an Education Toolkit Delivered by Soap Operas Among Communities Living in Extreme Poverty in Improving Vaccination Confidence in the Philippines: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 30;14:e77022. doi: 10.2196/77022.
- Individual participant dataSharing planned: Yes. According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.
Related trials for Measles
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Active, not recruitingPhase 1/2
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 1
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
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.
Xiaolin Wei, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational toolkit on MMR and polio vaccination in people with Measles and Polio, run by University of Toronto at 1 site in Philippines.
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 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: under way, not looking for participants, as of the sponsor's last update on 11 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 Philippines. 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?
This study is still under way. Results are not available in the source record yet.
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?
First-dose measles-containing-vaccine (MCV) coverage rate (time frame: 6 months after intervention). 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 NCT06218368, 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 11 Mar 2025.