Alcohol UseBNINCT02828267
Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
A study testing Brief Negotiational Intervention, Standard Booster and Personalized Booster in people with Alcohol Use, run by Duke University at 1 site in Tanzania.
Trial summary
A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Brief Negotiational Intervention, Standard Booster and Personalized Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Jul 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- be clinically sober at the time of enrollment
- have capacity to give informed consent
- converse in the local language Swahili or in English
- have either:
- reported ingesting alcohol in the 6 hours prior to injury,
- have a positive breathalyzer test, or
- have an Alcohol Use Disorder Identification Test with a score of ≥8.
Who cannot join
- <18 years of age
- being clinically intoxicated
- being injured so severely that participants do not have the capacity to give informed consent
- not able to converse in Swahili or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-30 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. Text based boosters have been proposed to prolong the impact of this intervention, either with a standardized or personalized content. The investigators will conduct a pilot study to test the feasibility of the study protocols, acceptance of the intervention, and patient enrollment and retention rates, as we prepare for a fully powered pragmatic randomized adaptive controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)
Read the detailed description
Research Design: This will be a pilot randomized adaptive feasibility and acceptability trial.
This will be a three stage trial where usual care, brief intervention and brief intervention with standard booster will be in the first stage. The second stage will drop the usual care arm. The third stage will keep an arm in stage two and a new arm, brief intervention with personalized booster. Since this is a feasibility trial, we will advance through potential adaptations, changing the enrollment procedures but not based on effectiveness testing as we are not powered for that endpoint. We have chosen brief intervention with standardized booster to continue in stage 3 to obtain more patient experience with the booster portion of the intervention.
Participants and Recruitment: The investigators will prospectively enroll (n=75, 10 usual care, 20 BNI, 24 BNI + standard booster and 16 BNI + Personalized Booster) patients who present to the KCMC ED for care of acute injuries and meet inclusion and exclusion criteria. Trained research nurses will describe the intervention as a health assessment, and eligible interested participants will be enrolled, provide informed consent and a randomization packet chosen. The research nurses will then administer patient demographic, injury, alcohol use surveys and the intervention if appropriate all lasting less than 45 minutes.
Follow-up Procedures: All groups will provide two phone numbers where participants can be reached in order to facilitate follow-up. All participants will be contacted at 6 weeks, 3 months and 6 months for follow-up survey administration. Follow up surveys are expected to be less than 20 minutes. All patients will be contacted by text message at the conclusion of the study to inform them about availability of the results of the study.
Feasibility Trial Outcomes: Using the RE-AIM framework, we will define the reach (enrollment/ retention), the preliminary effectiveness (reduction in DrInC score), adoption including patient acceptance, implementation (intervention fidelity) and maintance (sustainability features). The investigators will conduct a feasibility assessment subjectively through self-assessments as well as objectively through Event Analyses, understanding causes of deviations from protocol, intervention evaluations and questionnaires.
Study Procedures: To evaluate the study procedures, the investigators will evaluate any protocol deviation events, and compare length of survey times. The investigators will also perform assessments of intervention fidelity through reviewing recorded observations of BNI administration using the BNI Assessment Scale.
Reach: Enrollment and Retention The primary outcome measure will be recruitment and retention rates, anticipated at 30% and 60%, respectively. Secondarily, the investigators will qualitatively assess the inclusion and exclusion criteria, reasons for non-enrollment or non-retention, to the extent possible. Finally, the investigators will administer follow-up questions about compensation procedures in order to improve enrollment or retention.
Effectiveness: We will evaluate the DrInC (Drinker Inventory of Consequences), AUDIT (Alcohol Use Disorder Identification Test) scores, number of drinking days and number of binge drinking days. We are not powered to determine effectiveness, so this is a preliminary effectiveness only.
Adoption: We will evaluate patient acceptance and perception of effectiveness for the adoption of this intervention. The investigators will assess acceptability of participation in the trial and intervention through questions administered after the final follow-up time point for both the research team as well as participants. This will include assessment about the length of surveys, and method and quantity of follow-up.
Implementation: We will evaluate implementation preparedness with an evaluation of the time burden of the BNI, and intervention fidelity both for the BNI, and SMS boosters but also trial protocols.
Maintenance: We will determine sustainability through the burden of administration of the BNI as perceived by research nurses administering the intervention, the attitudes towards effectiveness of interventionists and participants, the cost and feasibility of this type of this adaptive clinical trial in this setting.
- Conditions
- Alcohol Use
- Being tested
- Brief Negotiational Intervention, Standard Booster, Personalized Booster
- Keywords
- Tanzania, Alcohol Use, Brief Intervention
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiational InterventionBehavioural
This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.
Standard BoosterBehavioural
This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use.
Personalized BoosterBehavioural
This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction |
| BNI | Experimental | In the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Receives: Behavioral: Brief Negotiational Intervention |
| BNI plus standard booster | Active comparator | In the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm. Receives: Behavioral: Brief Negotiational Intervention; Behavioral: Standard Booster |
| BNI plus personalized booster | Active comparator | In the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI. Receives: Behavioral: Brief Negotiational Intervention; Behavioral: Personalized Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
The average number of participants enrolled per week over the course of the study.
Measured: over the course of the study, approximately 8 months
Drinker Inventory of Consequences (DrInC) Score
The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Scales are combined to assess total adverse consequences, with higher scores indicating more adverse consequences. This is a mean and standard deviation of the number of consequences suffered by participants since enrollment. The total DrInC score is reported where is 0 (no consequences) to 50 (every consequence experienced).
Measured: 6 weeks, 3 months, 6 months
Secondary outcomes (2)
Retention Rates
Reported as the number of participants who complete each follow up visit.
Measured: 6 weeks, 3 months, 6 months
Alcohol Use Disorder Identification Test (AUDIT) Score
The AUDIT is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The scale ranges from 0 to 40; a score of 8 or more is considered to indicate hazardous or harmful alcohol use. Presented as the AUDIT mean score over the month prior to visit.
Measured: 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Jul 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by Duke 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an feasiblity trial of a three stage adaptive clinical trial. Stage one has three arms (UC, BNI, BNI+ Standard booster). Stage two drops usual care arm. Stage three continues the strongest arm for phase two (which was choosen as BNI + Standard Booster for this feasiblity trial not powered to determine efficacy) and a new arm BNI + Personalized Booster.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Catherine A. Staton, MD, MSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828267
- Sponsor's protocol ID
- Pro00062061
- Other IDs
- K01TW010000
- Acronym
- BNI
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2016
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.
PubMed 39052647Staton CA, Friedman K, Phillips AJ, Minnig MC, Sakita FM, Ngowi KM, Suffoletto B, Hirshon JM, Swahn M, Mmbaga BT, Vissoci JRN. Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania. PLoS One. 2023 Aug 3;18(8):e0288458. doi: 10.1371/journal.pone.0288458. eCollection 2023.
PubMed 37535693
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
- ClinicalTrials.gov ID
- NCT02828267
- Acronym / sponsor ID
- BNI / Pro00062061
- Conditions
- Alcohol Use
- Keywords
- Tanzania, Alcohol Use, Brief Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 11 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-30 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. Text based boosters have been proposed to prolong the impact of this intervention, either with a standardized or personalized content. The investigators will conduct a pilot study to test the feasibility of the study protocols, acceptance of the intervention, and patient enrollment and retention rates, as we prepare for a fully powered pragmatic randomized adaptive controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)
Detailed description
Research Design: This will be a pilot randomized adaptive feasibility and acceptability trial.
This will be a three stage trial where usual care, brief intervention and brief intervention with standard booster will be in the first stage. The second stage will drop the usual care arm. The third stage will keep an arm in stage two and a new arm, brief intervention with personalized booster. Since this is a feasibility trial, we will advance through potential adaptations, changing the enrollment procedures but not based on effectiveness testing as we are not powered for that endpoint. We have chosen brief intervention with standardized booster to continue in stage 3 to obtain more patient experience with the booster portion of the intervention.
Participants and Recruitment: The investigators will prospectively enroll (n=75, 10 usual care, 20 BNI, 24 BNI + standard booster and 16 BNI + Personalized Booster) patients who present to the KCMC ED for care of acute injuries and meet inclusion and exclusion criteria. Trained research nurses will describe the intervention as a health assessment, and eligible interested participants will be enrolled, provide informed consent and a randomization packet chosen. The research nurses will then administer patient demographic, injury, alcohol use surveys and the intervention if appropriate all lasting less than 45 minutes.
Follow-up Procedures: All groups will provide two phone numbers where participants can be reached in order to facilitate follow-up. All participants will be contacted at 6 weeks, 3 months and 6 months for follow-up survey administration. Follow up surveys are expected to be less than 20 minutes. All patients will be contacted by text message at the conclusion of the study to inform them about availability of the results of the study.
Feasibility Trial Outcomes: Using the RE-AIM framework, we will define the reach (enrollment/ retention), the preliminary effectiveness (reduction in DrInC score), adoption including patient acceptance, implementation (intervention fidelity) and maintance (sustainability features). The investigators will conduct a feasibility assessment subjectively through self-assessments as well as objectively through Event Analyses, understanding causes of deviations from protocol, intervention evaluations and questionnaires.
Study Procedures: To evaluate the study procedures, the investigators will evaluate any protocol deviation events, and compare length of survey times. The investigators will also perform assessments of intervention fidelity through reviewing recorded observations of BNI administration using the BNI Assessment Scale.
Reach: Enrollment and Retention The primary outcome measure will be recruitment and retention rates, anticipated at 30% and 60%, respectively. Secondarily, the investigators will qualitatively assess the inclusion and exclusion criteria, reasons for non-enrollment or non-retention, to the extent possible. Finally, the investigators will administer follow-up questions about compensation procedures in order to improve enrollment or retention.
Effectiveness: We will evaluate the DrInC (Drinker Inventory of Consequences), AUDIT (Alcohol Use Disorder Identification Test) scores, number of drinking days and number of binge drinking days. We are not powered to determine effectiveness, so this is a preliminary effectiveness only.
Adoption: We will evaluate patient acceptance and perception of effectiveness for the adoption of this intervention. The investigators will assess acceptability of participation in the trial and intervention through questions administered after the final follow-up time point for both the research team as well as participants. This will include assessment about the length of surveys, and method and quantity of follow-up.
Implementation: We will evaluate implementation preparedness with an evaluation of the time burden of the BNI, and intervention fidelity both for the BNI, and SMS boosters but also trial protocols.
Maintenance: We will determine sustainability through the burden of administration of the BNI as perceived by research nurses administering the intervention, the attitudes towards effectiveness of interventionists and participants, the cost and feasibility of this type of this adaptive clinical trial in this setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is an feasiblity trial of a three stage adaptive clinical trial. Stage one has three arms (UC, BNI, BNI+ Standard booster). Stage two drops usual care arm. Stage three continues the strongest arm for phase two (which was choosen as BNI + Standard Booster for this feasiblity trial not powered to determine efficacy) and a new arm BNI + Personalized Booster.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction |
| BNI | Experimental | Behavioral: Brief Negotiational InterventionIn the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. |
| BNI plus standard booster | Active comparator | Behavioral: Brief Negotiational Intervention, Behavioral: Standard BoosterIn the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm. |
| BNI plus personalized booster | Active comparator | Behavioral: Brief Negotiational Intervention, Behavioral: Personalized BoosterIn the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >18 years of age
- be clinically sober at the time of enrollment
- have capacity to give informed consent
- converse in the local language Swahili or in English
- have either:
Key exclusion criteria (4 listed)
- <18 years of age
- being clinically intoxicated
- being injured so severely that participants do not have the capacity to give informed consent
- not able to converse in Swahili or English
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 |
|---|---|---|
| Brief Negotiational InterventionThis is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use. | Behavioural | BNI, BNI plus personalized booster, BNI plus standard booster |
| Standard BoosterThis SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. | Behavioural | BNI plus standard booster |
| Personalized BoosterThis SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content. | Behavioural | BNI plus personalized booster |
Primary outcome
Enrollment Rate
Time frame: over the course of the study, approximately 8 months
The average number of participants enrolled per week over the course of the study.
Drinker Inventory of Consequences (DrInC) Score
Time frame: 6 weeks, 3 months, 6 months
The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Scales are combined to assess total adverse consequences, with higher scores indicating more adverse consequences. This is a mean and standard deviation of the number of consequences suffered by participants since enrollment. The total DrInC score is reported where is 0 (no consequences) to 50 (every consequence experienced).
2 secondary outcomes
Retention Rates
Time frame: 6 weeks, 3 months, 6 months
Alcohol Use Disorder Identification Test (AUDIT) Score
Time frame: 6 weeks, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39052647Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.
- Derived from this study: PubMed 37535693Staton CA, Friedman K, Phillips AJ, Minnig MC, Sakita FM, Ngowi KM, Suffoletto B, Hirshon JM, Swahn M, Mmbaga BT, Vissoci JRN. Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania. PLoS One. 2023 Aug 3;18(8):e0288458. doi: 10.1371/journal.pone.0288458. eCollection 2023.
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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.
Catherine A. Staton, MD, MSc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Negotiational Intervention, Standard Booster and Personalized Booster in people with Alcohol Use, run by Duke University at 1 site in Tanzania.
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 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2021. 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 Tanzania. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment Rate (time frame: over the course of the study, approximately 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828267, which also lists 2 linked publications.
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 Aug 2021.