Contraception BehaviorDrEricNCT04969289
A Trial of an Adolescent Male Sexual Health Intervention
A study testing Dr. Eric Digital Health Intervention in people with Contraception Behavior, run by Columbia University at 1 site in United States.
Trial summary
Early unintended fatherhood and rates of sexually transmitted infections remain national concerns, disproportionately affecting minority, underserved adolescent males, many of whom frequently use emergency departments (EDs) for medical care. Read more about this study
- Who is it for?
- Ages 14 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Dr. Eric Digital Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 20 Nov 2022
- 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 14 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ED male adolescent patients aged 14-21 years
- sexually active (vaginal intercourse) with females in the past 3 months
Who cannot join
- do not own a mobile phone
- too ill per the attending
- are cognitively impaired
- does not speak English
- want their partner to become pregnant in the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10528
About this study
Official title: A Digital Intervention to Improve the Sexual and Reproductive Health of Male Adolescent Emergency Department Patients
Early unintended fatherhood and rates of sexually transmitted infections remain national concerns, disproportionately affecting minority, underserved adolescent males, many of whom frequently use emergency departments (EDs) for medical care. EDs must implement effective sexual and reproductive health interventions that are evidence-based and reproducible. This research will conduct pilot testing of a personalized and interactive digital intervention specifically targeting adolescent males entitled Dr. Eric that is theory-based, user-informed, and scalable across EDs.
Read the detailed description
Emergency Departments (EDs) care for 19 million adolescents each year, the majority of whom are low-income, racial and ethnic minorities, and participating in risky sexual behaviors. Despite a growing interest in expanding the role of the ED to provide preventive care, ED providers identify limited resources and time constraints as barriers to the implementation of public health interventions. Novel interventions are needed that fit efficiently within the ED workflow. The prior work of these investigators highlighted a significant public health problem-high risk sex among the adolescent male ED population. The investigators demonstrated that adolescent male ED patients are frequently having sex without condoms, increasing their risk of unintended early fatherhood and sexually transmitted infections (STI). These adolescents admit to low knowledge of effective contraceptive methods and having few discussions with medical providers and sexual partners about these methods. However, these male adolescents are receptive to sexual and reproductive health (SRH) interventions, particularly during the ED visit and via digital technology. They are particularly interested in interventions that feel relatable and are from a trustworthy source. To date, no intervention has successfully increased contraceptive use among this high risk, hard-to-reach ED population. Additionally, although evidence suggests that SRH digital interventions can improve SRH health, few interventions specifically target males. To improve adolescent SRH outcomes, the investigators have gathered an accomplished team with expertise in adolescent health, ED-based clinical trials, mobile health, and user-informed digital interventions. They created a novel intervention of an ED-based, theory-based, user-informed SRH digital intervention that includes a tailored educational app and 3 months of personalized and interactive text messaging. In this study, the investigators will conduct a pilot randomized controlled trial of Dr. Eric (Emergency Room Interventions to improve Care) to assess implementation outcomes and potential effectiveness. The investigators hypothesize that the Dr. Eric intervention will be feasible in the ED setting, be acceptable to adolescent males, demonstrate fidelity, and be adopted by users. The investigators also hypothesize that sexually active adolescent male ED patients who receive Dr. Eric will more often have consistent condom use than those who receive standard outpatient referral alone. These data will inform a subsequent multi-center clinical trial with sufficient power to measure clinically significant changes in consistent condom use. Ultimately, a digital ED-based intervention that is effective and automated can be utilized by other EDs as a reproducible and scalable means to promote sexual and reproductive preventive care, decrease unintended early fatherhood and STI risk among adolescent males, and improve adolescent health outcomes throughout the United States.
- Conditions
- Contraception Behavior
- Being tested
- Dr. Eric Digital Health Intervention
- Keywords
- Digital health, Sexual health, Sexual education, Adolescent health, Mobile health
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr. Eric Digital Health InterventionBehavioural
Dr. Eric is a user-informed, theory-based, digital health intervention that aims to improve adolescent male SRH. This ED-based intervention consists of two parts-an interactive, tailored app and 3 months of personalized, two-way text messaging. It is based on an evidence-based sexual health curriculum we developed using established behavioral theories, prior literature, input from key stakeholders, qualitative patient interviews, and our prior ED-based work.
| Study group | Role | What they receive |
|---|---|---|
| Dr. Eric Digital Health Intervention | Experimental | Participants will interact with an ED-based iPad and the Dr. Eric app for a recorded period of time. After completion, an animated video will explain the ERIC texting program and "live" office hours. The participant enters his phone number and then receives a welcome text. Weekly texts are sent directly to the participant phone via short message service (SMS). Receives: Behavioral: Dr. Eric Digital Health Intervention |
| Standard of Care | No intervention | Participants randomized to the SC arm will receive standard medical care as determined by the ED provider, which is typically referral to a primary care or adolescent provider. Mobile telephone numbers will be collected for follow up purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eligible Participants Who Agreed to be Enrolled in the Study
Implementation, feasibility: This outcome is designed to measure feasibility - the extent to which an innovation can be used in a setting. The investigators will measure the number of participants who are eligible, and agree to be enrolled into the study.
Measured: From day 1 of enrollment until the final day of enrollment (1 year)
Number of Participants That Are Lost to Follow up (at Each Time Point)
Implementation, feasibility: This outcome is to measure feasibility for both arms in which feasibility is defined as the extent to which an innovation can be used in a setting. The investigators will measure the number of participants in each arm that are lost to follow up in each respective arm at the 6 and 13 week time point. Lost to follow up means that we tried to contact the participant to assess outcome measures but they did not respond to texts or phone calls.
Measured: 6 and 13 weeks
Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)
Implementation, acceptability: This outcome is to measure acceptability for the intervention group only. Acceptability is the extent to which the innovation is agreeable to a stakeholder. The investigators asked the Agree/Disagree question of "Dr. Eric meets my approval," as self-reported after app completion.
Measured: From day 1 of enrollment until the final day of enrollment (1 year)
The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)
Implementation, adoption: This outcome is for the intervention group only. Th investigators assessed adoption by measuring the number of intervention participants who interacted with all 5 educational modules, based off of data that is recorded by the app.
Measured: From day 1 of enrollment until the final day of enrollment (1 year)
Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY)
Implementation, fidelity: This outcome is for the intervention group only. Fidelity is the extent to which an intervention is used as intended. This outcome measures the number of participants in the intervention group who opt out of the texting messaging component of the program.
Measured: 3 months
Percentage of Condom Use Among Participants
Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome and only includes participants who completed follow-up at 13 weeks. Percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentage of condom use within each arm.
Measured: 3 months (or 13 weeks)
Percentage of Condom Use Among Participants
Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome. This outcome only includes participants who completed follow-up at 6 weeks and were sexually active in the prior 4 weeks. The percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentages of condom use within each arm.
Measured: 6 weeks
Secondary outcomes (7)
Number of Participants Who Had Intercourse Over the Past 4 Weeks
Efficacy, Abstinent: This outcome is self-reported where participants are asked if they had penile-vaginal intercourse over the past 4 week. The binary outcome is measured from a "Yes" or "No" response.
Measured: 3 month (13 weeks)
Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months
Efficacy, Talked to a partner about ways to prevent pregnancy over the past 3 months: This outcome is based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.
Measured: 3 month (13 weeks)
Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months
Efficacy, Tested for a sexually transmitted infection over the past 3 months: This outcome is based on self-reported responses on the follow-up survey, in which the binary outcome is measured from a "Yes" or "No" response.
Measured: 3 month (13 weeks)
Number of Participants Who Tested for HIV Over the Past 3 Months
Efficacy, Tested for HIV over the past 3 months: This outcome was based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.
Measured: 3 month (13 weeks)
Number of Participants Who Consistently Used Condoms at Every Intercourse
Efficacy, Consistent Condom Use at Every Intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks. Answere are binary (yes/no) to using a condom at every intercourse over the past 3 months.
Measured: 3 months (or 13 weeks)
Number of Participants Who Used a Condom at Last Intercourse
Efficacy, Use a condom at last intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks and were sexually active. Answers are binary (yes/no) to the question if a condom was used at last intercourse.
Measured: 3 months (or 13 weeks)
Number of Participants Who Used Any Contraceptive Method at Last Intercourse
Efficacy, Used any method of contraception at last intercourse: This outcome is based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.
Measured: 3 month (13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start26 Jul 2021
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
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.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Lauren S. Chernick, Columbia University
- Investigators
- Lauren Chernick, MD MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969289
- Sponsor's protocol ID
- AAAT6680
- Other IDs
- R21NR019181
- Acronym
- DrEric
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2021
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include self-reported demographic and behavioral data from baseline questionnaires, telephone follow up, and text message data collection. It will also contain usability testing information. All participants will be assigned a unique identifier and all data will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention to Improve the Sexual and Reproductive Health of Male Adolescent Emergency Department Patients
- ClinicalTrials.gov ID
- NCT04969289
- Acronym / sponsor ID
- DrEric / AAAT6680
- Conditions
- Contraception Behavior
- Keywords
- Digital health, Sexual health, Sexual education, Adolescent health, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early unintended fatherhood and rates of sexually transmitted infections remain national concerns, disproportionately affecting minority, underserved adolescent males, many of whom frequently use emergency departments (EDs) for medical care. EDs must implement effective sexual and reproductive health interventions that are evidence-based and reproducible. This research will conduct pilot testing of a personalized and interactive digital intervention specifically targeting adolescent males entitled Dr. Eric that is theory-based, user-informed, and scalable across EDs.
Detailed description
Emergency Departments (EDs) care for 19 million adolescents each year, the majority of whom are low-income, racial and ethnic minorities, and participating in risky sexual behaviors. Despite a growing interest in expanding the role of the ED to provide preventive care, ED providers identify limited resources and time constraints as barriers to the implementation of public health interventions. Novel interventions are needed that fit efficiently within the ED workflow. The prior work of these investigators highlighted a significant public health problem-high risk sex among the adolescent male ED population. The investigators demonstrated that adolescent male ED patients are frequently having sex without condoms, increasing their risk of unintended early fatherhood and sexually transmitted infections (STI). These adolescents admit to low knowledge of effective contraceptive methods and having few discussions with medical providers and sexual partners about these methods. However, these male adolescents are receptive to sexual and reproductive health (SRH) interventions, particularly during the ED visit and via digital technology. They are particularly interested in interventions that feel relatable and are from a trustworthy source. To date, no intervention has successfully increased contraceptive use among this high risk, hard-to-reach ED population. Additionally, although evidence suggests that SRH digital interventions can improve SRH health, few interventions specifically target males. To improve adolescent SRH outcomes, the investigators have gathered an accomplished team with expertise in adolescent health, ED-based clinical trials, mobile health, and user-informed digital interventions. They created a novel intervention of an ED-based, theory-based, user-informed SRH digital intervention that includes a tailored educational app and 3 months of personalized and interactive text messaging. In this study, the investigators will conduct a pilot randomized controlled trial of Dr. Eric (Emergency Room Interventions to improve Care) to assess implementation outcomes and potential effectiveness. The investigators hypothesize that the Dr. Eric intervention will be feasible in the ED setting, be acceptable to adolescent males, demonstrate fidelity, and be adopted by users. The investigators also hypothesize that sexually active adolescent male ED patients who receive Dr. Eric will more often have consistent condom use than those who receive standard outpatient referral alone. These data will inform a subsequent multi-center clinical trial with sufficient power to measure clinically significant changes in consistent condom use. Ultimately, a digital ED-based intervention that is effective and automated can be utilized by other EDs as a reproducible and scalable means to promote sexual and reproductive preventive care, decrease unintended early fatherhood and STI risk among adolescent males, and improve adolescent health outcomes throughout the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
| Arm | Type | Receives |
|---|---|---|
| Dr. Eric Digital Health Intervention | Experimental | Behavioral: Dr. Eric Digital Health InterventionParticipants will interact with an ED-based iPad and the Dr. Eric app for a recorded period of time. After completion, an animated video will explain the ERIC texting program and "live" office hours. The participant enters his phone number and then receives a welcome text. Weekly texts are sent directly to the participant phone via short message service (SMS). |
| Standard of Care | No intervention | –Participants randomized to the SC arm will receive standard medical care as determined by the ED provider, which is typically referral to a primary care or adolescent provider. Mobile telephone numbers will be collected for follow up purposes. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ED male adolescent patients aged 14-21 years
- sexually active (vaginal intercourse) with females in the past 3 months
Key exclusion criteria (5 listed)
- do not own a mobile phone
- too ill per the attending
- are cognitively impaired
- does not speak English
- want their partner to become pregnant in the next year
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 |
|---|---|---|
| Dr. Eric Digital Health InterventionDr. Eric is a user-informed, theory-based, digital health intervention that aims to improve adolescent male SRH. This ED-based intervention consists of two parts-an interactive, tailored app and 3 months of personalized, two-way text messaging. It is based on an evidence-based sexual health curriculum we developed using established behavioral theories, prior literature, input from key stakeholders, qualitative patient interviews, and our prior ED-based work. | Behavioural | Dr. Eric Digital Health Intervention |
Primary outcome
Number of Eligible Participants Who Agreed to be Enrolled in the Study
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
Implementation, feasibility: This outcome is designed to measure feasibility - the extent to which an innovation can be used in a setting. The investigators will measure the number of participants who are eligible, and agree to be enrolled into the study.
Number of Participants That Are Lost to Follow up (at Each Time Point)
Time frame: 6 and 13 weeks
Implementation, feasibility: This outcome is to measure feasibility for both arms in which feasibility is defined as the extent to which an innovation can be used in a setting. The investigators will measure the number of participants in each arm that are lost to follow up in each respective arm at the 6 and 13 week time point. Lost to follow up means that we tried to contact the participant to assess outcome measures but they did not respond to texts or phone calls.
Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
Implementation, acceptability: This outcome is to measure acceptability for the intervention group only. Acceptability is the extent to which the innovation is agreeable to a stakeholder. The investigators asked the Agree/Disagree question of "Dr. Eric meets my approval," as self-reported after app completion.
The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
Implementation, adoption: This outcome is for the intervention group only. Th investigators assessed adoption by measuring the number of intervention participants who interacted with all 5 educational modules, based off of data that is recorded by the app.
Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY)
Time frame: 3 months
Implementation, fidelity: This outcome is for the intervention group only. Fidelity is the extent to which an intervention is used as intended. This outcome measures the number of participants in the intervention group who opt out of the texting messaging component of the program.
Percentage of Condom Use Among Participants
Time frame: 3 months (or 13 weeks)
Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome and only includes participants who completed follow-up at 13 weeks. Percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentage of condom use within each arm.
Percentage of Condom Use Among Participants
Time frame: 6 weeks
Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome. This outcome only includes participants who completed follow-up at 6 weeks and were sexually active in the prior 4 weeks. The percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentages of condom use within each arm.
7 secondary outcomes
Number of Participants Who Had Intercourse Over the Past 4 Weeks
Time frame: 3 month (13 weeks)
Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months
Time frame: 3 month (13 weeks)
Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months
Time frame: 3 month (13 weeks)
Number of Participants Who Tested for HIV Over the Past 3 Months
Time frame: 3 month (13 weeks)
Number of Participants Who Consistently Used Condoms at Every Intercourse
Time frame: 3 months (or 13 weeks)
Number of Participants Who Used a Condom at Last Intercourse
Time frame: 3 months (or 13 weeks)
Number of Participants Who Used Any Contraceptive Method at Last Intercourse
Time frame: 3 month (13 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The final dataset will include self-reported demographic and behavioral data from baseline questionnaires, telephone follow up, and text message data collection. It will also contain usability testing information. All participants will be assigned a unique identifier and all data will remain confidential.
Related trials for Contraception Behavior
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception
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.
Lauren Chernick, MD MSc principal investigator
Columbia 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 Dr. Eric Digital Health Intervention in people with Contraception Behavior, run by Columbia University at 1 site in United States.
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 5 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 9 Jul 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 United States. 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 6 Jun 2024). 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?
Number of Eligible Participants Who Agreed to be Enrolled in the Study (time frame: From day 1 of enrollment until the final day of enrollment (1 year)). The study lists 7 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 9 Jul 2024.