COVID 19Phase 2NCAP2NCT06614361
Community-based Behavioral Intervention to Increase Vaccination Using MOST
A Phase 2 study testing Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages in people with COVID 19 and Influenza, run by New York University.
Trial summary
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Apr 2025
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American/ Black and Latino Persons: An Optimization Randomized Controlled Trial
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose.
Read the detailed description
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose. Specific aims are: Aim 1) identify which of four components contribute meaningfully to improvement in the outcomes; Aim 2) identify mediators (e.g., altruism, norms) and moderators (e.g., sociodemographic characteristics, distrust) of the effects of each component; and Aim 3) build the most cost-effective intervention package(s). Participants will be randomly assigned to an experimental condition, and assessed at 3- and 6-months post-baseline; N=45 participants will engage in qualitative in-depth interviews. We will also uncover, describe, and plan for implementation issues so the optimized intervention can be rapidly scaled up by community-based and outpatient health organizations.
- Being tested
- Health education on COVID and flu vaccination, Nurse-led shared decision-making, Text messages, Lottery prize for vaccination, Peer navigation
- Keywords
- COVID-19, influenza, vaccination
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education on COVID and flu vaccinationBehavioural
1 session (30 min) with a health educator on vaccination
Nurse-led shared decision-makingBehavioural
1 session and FU calls with a trained nurse
Text messagesBehavioural
Health \& wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Lottery prize for vaccinationBehavioural
Modest lottery prize for COVID vaccination
Peer navigationBehavioural
Peer navigation (4 months duration, contact as needed).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition 1 | Experimental | Core session Receives: Behavioral: Health education on COVID and flu vaccination |
| Experimental Condition 12 | Experimental | Core session, nurse-led SDM Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Peer navigation |
| Experimental Condition 3 | Experimental | Core session, Text messages Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages |
| Experimental Condition 4 | Experimental | Core session, nurse-led SDM, text messages Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages |
| Experimental Condition 5 | Experimental | Core, lottery prize Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Lottery prize for vaccination |
| Experimental Condition 6 | Experimental | Core session, nurse-led SDM, lottery prize Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Lottery prize for vaccination |
| Experimental Condition 7 | Experimental | Core, text messages, lottery prize Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Lottery prize for vaccination |
| Experimental Condition 8 | Experimental | Core, nurse-led SDM, text messages, lottery prize Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Lottery prize for vaccination |
| Experimental Condition 9 | Experimental | Core, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Peer navigation |
| Experimental Condition 10 | Experimental | Core, nurse-led SDM, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Peer navigation |
| Experimental Condition 11 | Experimental | core, text messages, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Peer navigation |
| Experimental Condition 13 | Experimental | core, lottery prize, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation |
| Experimental Condition 14 | Experimental | core, SDM, lottery prize, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation |
| Experimental Condition 15 | Experimental | core, text messages, lottery, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation |
| Experimental Condition 16 | Experimental | core, SDM, text message, lottery, peer navigation Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation |
| Experimental Condition 2 | Experimental | Core, SDM Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination for COVID-19
Vaccination for COVID-19 with documentary evidence
Measured: 3- and 6-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: terminated by NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Manhattan Improvement Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614361
- Sponsor's protocol ID
- IRB-FY2025-9851
- Acronym
- NCAP2
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American/ Black and Latino Persons: An Optimization Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06614361
- Acronym / sponsor ID
- NCAP2 / IRB-FY2025-9851
- Keywords
- COVID-19, influenza, vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: terminated by NIH
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Northern Manhattan Improvement Corporation
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Sep 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.
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose.
Detailed description
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose. Specific aims are: Aim 1) identify which of four components contribute meaningfully to improvement in the outcomes; Aim 2) identify mediators (e.g., altruism, norms) and moderators (e.g., sociodemographic characteristics, distrust) of the effects of each component; and Aim 3) build the most cost-effective intervention package(s). Participants will be randomly assigned to an experimental condition, and assessed at 3- and 6-months post-baseline; N=45 participants will engage in qualitative in-depth interviews. We will also uncover, describe, and plan for implementation issues so the optimized intervention can be rapidly scaled up by community-based and outpatient health organizations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition 1 | Experimental | Behavioral: Health education on COVID and flu vaccinationCore session |
| Experimental Condition 12 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Text messages, Behavioral: Peer navigationCore session, nurse-led SDM |
| Experimental Condition 3 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Text messagesCore session, Text messages |
| Experimental Condition 4 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Text messagesCore session, nurse-led SDM, text messages |
| Experimental Condition 5 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Lottery prize for vaccinationCore, lottery prize |
| Experimental Condition 6 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Lottery prize for vaccinationCore session, nurse-led SDM, lottery prize |
| Experimental Condition 7 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Text messages, Behavioral: Lottery prize for vaccinationCore, text messages, lottery prize |
| Experimental Condition 8 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Text messages, Behavioral: Lottery prize for vaccinationCore, nurse-led SDM, text messages, lottery prize |
| Experimental Condition 9 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Peer navigationCore, peer navigation |
| Experimental Condition 10 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Peer navigationCore, nurse-led SDM, peer navigation |
| Experimental Condition 11 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Text messages, Behavioral: Peer navigationcore, text messages, peer navigation |
| Experimental Condition 13 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Lottery prize for vaccination, Behavioral: Peer navigationcore, lottery prize, peer navigation |
| Experimental Condition 14 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Lottery prize for vaccination, Behavioral: Peer navigationcore, SDM, lottery prize, peer navigation |
| Experimental Condition 15 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Text messages, Behavioral: Lottery prize for vaccination, Behavioral: Peer navigationcore, text messages, lottery, peer navigation |
| Experimental Condition 16 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-making, Behavioral: Text messages, Behavioral: Lottery prize for vaccination, Behavioral: Peer navigationcore, SDM, text message, lottery, peer navigation |
| Experimental Condition 2 | Experimental | Behavioral: Health education on COVID and flu vaccination, Behavioral: Nurse-led shared decision-makingCore, SDM |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Health education on COVID and flu vaccination1 session (30 min) with a health educator on vaccination | Behavioural | Experimental Condition 1, Experimental Condition 10, Experimental Condition 11, Experimental Condition 12, Experimental Condition 13, Experimental Condition 14, Experimental Condition 15, Experimental Condition 16, Experimental Condition 2, Experimental Condition 3, Experimental Condition 4, Experimental Condition 5, Experimental Condition 6, Experimental Condition 7, Experimental Condition 8, Experimental Condition 9 |
| Nurse-led shared decision-making1 session and FU calls with a trained nurse | Behavioural | Experimental Condition 10, Experimental Condition 12, Experimental Condition 14, Experimental Condition 16, Experimental Condition 2, Experimental Condition 4, Experimental Condition 6, Experimental Condition 8 |
| Text messagesHealth \& wellness interactive text message (TM) intervention (12 weeks, 2 texts/week) | Behavioural | Experimental Condition 11, Experimental Condition 12, Experimental Condition 15, Experimental Condition 16, Experimental Condition 3, Experimental Condition 4, Experimental Condition 7, Experimental Condition 8 |
| Lottery prize for vaccinationModest lottery prize for COVID vaccination | Behavioural | Experimental Condition 13, Experimental Condition 14, Experimental Condition 15, Experimental Condition 16, Experimental Condition 5, Experimental Condition 6, Experimental Condition 7, Experimental Condition 8 |
| Peer navigationPeer navigation (4 months duration, contact as needed). | Behavioural | Experimental Condition 10, Experimental Condition 11, Experimental Condition 12, Experimental Condition 13, Experimental Condition 14, Experimental Condition 15, Experimental Condition 16, Experimental Condition 9 |
Primary outcome
Vaccination for COVID-19
Time frame: 3- and 6-months post-baseline
Vaccination for COVID-19 with documentary evidence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages in people with COVID 19 and Influenza, run by New York University.
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 0 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: withdrawn, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 for COVID-19 (time frame: 3- and 6-months post-baseline). 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 29 Apr 2025.