HIV - Human Immunodeficiency VirusNCT07631104
Improving the HIV Care Continuum With mHealth Technology
A study testing MindBodyU Intervention in people with HIV - Human Immunodeficiency Virus and HIV Antiretroviral Therapy (ART) Adherence, run by University of South Carolina at 1 site in United States.
Trial summary
Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence, mHealth Application
- What is being tested?
- MindBodyU Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jun 2028
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 16 and 25 years
- Diagnosed with HIV
- Resident of South Carolina
- Proficient in English
Who cannot join
- Under 16 years of age or over 25 years of age
- Is not a person living with HIV
- Is not a resident of South Carolina
- Is not proficient in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Weaver, BS contact
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Improving the HIV Care Continuum for Youth in the Deep South Through Mobile Health Technology
Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.
Read the detailed description
In this study, investigators will conduct a brief pilot trial of the MindBodyU intervention--a digital health intervention that is delivered via a smartphone application ('app'). In the study, a total of 40 youth living with HIV (YLHIV) be provided with access to the MindBodyU app. Investigators will collect survey data from youth before youth install the app on their personal phone and again at 12-weeks and 6-months to assess feasibility and acceptability of the intervention, as well as preliminary outcomes (e.g., engagement/retention in care, adherence, viral suppression).
- Conditions
- HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence, mHealth Application, mHealth Intervention, Continuum of Care, Youth With HIV
- Being tested
- MindBodyU Intervention
- Keywords
- Youth living with HIV (YLHIV), immunology, HIV, adolescents, emerging/young adults, eHealth/mHealth/digital health, adherence/self-management, psychosocial intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindBodyU InterventionBehavioural
Also called MindBodyU App
The MindBodyU app is an mHealth intervention that was developed based on input from youth living with HIV, HIV providers, and community-based organizations. The app includes multiple features designed to promote HIV care engagement, medication adherence, and psychosocial wellbeing for youth living with HIV in South Carolina. Users of the app will have the opportunity to create anonymous profiles in which they can access resources related to HIV, behavioral health, sexual health, and other social determinants of health. The app also has features that enable youth to monitor and track health behaviors (e.g., appointment reminders, medication adherence), message healthcare professionals with general health questions, and engage in moderated online forums with HIV providers and other YLHIV.
| Study group | Role | What they receive |
|---|---|---|
| MindBodyU Intervention | Experimental | This is a single group, one arm trial in which participants (youth living with HIV aged 16-25 years who are current residents of South Carolina) will receive access to a mobile health (mHealth) intervention called MindBodyU that is delivered via smartphone application (app) and designed to improve engagement in care, medication adherence, and psychosocial wellbeing. The intervention includes app-based learning content, daily prompts for medication adherence, appointment reminders, behavioral health symptom tracking, ability to connect with content experts, and ability to seek feedback/support from other users. Participants will be instructed to use the intervention over a 12-week period, and will complete surveys at baseline, 12-weeks, and 6-months to assess for feasibility and acceptability of the intervention, as well as participants' engagement/retention in care, adherence to antiretroviral therapy, viral suppression, and psychosocial wellbeing. Receives: Behavioral: MindBodyU Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Retention
Study retention will be measured by how many participants are retained in the study at 12-weeks (i.e., complete the 12-week follow-up. Investigators will define good retention as at least 70% of participants retained in the study at 12-weeks. Study retention will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.
Measured: From enrollment to 12-weeks
Acceptability of the MindBodyU Intervention
This outcome is acceptability of the MindBodyU Intervention, which refers to whether adolescents and young adults find the intervention to be likable, enjoyable, engaging, and culturally appropriate. Acceptability will be measured by the Acceptability of Intervention Measure (AIM), and operationalized as a mean score of 3 or more on 5-point Likert scale for the following items: 'MindBodyU meets my approval', 'MindBodyU is appealing to me', and 'I like the MindBodyU app'. It will also be measured by participant scores on the item, 'The MindBodyU app aligns with my values' and 'The MindBodyU app is a good fit for me' (i.e., score of 3 or more on 5-point Likert scale).
Measured: From enrollment to 12-weeks
Adherence to Antiretroviral Therapy (ART)
This outcome assesses participants' self-reported adherence to antiretroviral therapy (ART). The outcome is measured by the following items:
- Are you currently taking medications for HIV (also called antiretroviral therapy or ART)? (Yes, No, I Don't Know)
- In the last 30 days, on how many days did you miss at least one dose of any of your HIV medications (ART)? I missed ______ days out of the last 30 days (0-30)
- In the last 30 days, how often did you take your HIV medication in the way you were supposed to? (Never, Rarely, Sometimes, Usually, Almost always, Always)
- In the last 30 days, how good a job did you do at taking HIV medication in the way you were supposed to? (Very poor, Poor, Fair, Good, Very good, Excellent)
Measured: From enrollment to 12-weeks; follow-up at 6-months
Viral Suppression
This outcome measures participants' self-reported viral suppression. It will be measured by one item:
'To the best of your knowledge, are you currently virally suppressed? Viral suppression means that you have a viral load that is ≤ 200 copies/ml. This is also called having an 'undetectable' viral load.' (Yes, I am virally suppressed; No, I am not virally suppressed; I don't know if I am virally suppressed)
Measured: From enrollment to 12-weeks; follow-up at 6-months
HIV Care Engagement
This outcome measures youths' engagement with their HIV care and their self-efficacy to engage in HIV care. It is measured by two survey items:
- To the best of your knowledge, how many times have you missed a visit with your HIV care provider in the past 12 months? (Never missed a visit, Missed 1 visit, Missed 2-3 visits, Missed 4 or more visits, N/A - I haven't had any scheduled visits in the past 12 months); and 2) How sure are you that you could always schedule and keep your HIV appointments in the next year? (Very Unsure, Unsure, Neutral, Sure, Very Sure).
Measured: From enrollment to 12-weeks; follow-up at 6-months
App engagement
App engagement will be measured by the percent of participants who use the app on a weekly basis across the 12-week period. Investigators will define good app engagement as at least 60% of participants having weekly active use of the app during the 12-week period. App engagement will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.
Measured: From enrollment to 12-weeks
Perceived Burden of the MindBodyU App
This outcome measures youths' perceived burden of using the MindBodyU app. Three items will be used to measure perceived burden, and low perceived burden will be defined as a mean score of 3 or less on a 5-point Likert scale for these 3 items: 'This app fits easily into my daily routine [Reverse]', 'Using this app took too much time', and 'This app was a burden to use'.
Measured: From enrollment to 12-weeks
Perceived Feasibility of the MindBodyU App
This outcome measures youths' perceived feasibility of the MindBodyU app. It will be measured with the 3-item Feasibility of Intervention Measure (FIM). Feasibility will be defined as a mean score of 3 or more on 5-point Likert scale for the following 3 items: 'Using MindBodyU was possible', 'Using MindBodyU was doable', and 'Using MindBodyU was easy to use'.
Measured: From enrollment to 12-weeks
Secondary outcomes (5)
HIV Stigma
This outcome evaluates youths' experiences, feelings, and opinions about HIV-related stigma. The outcome is measured by 12 items that are answered on a 4-point Likert scale (strong disagree to strongly agree) and assess participants' feelings and behaviors related to stigma (e.g., feeling like they have to keep their HIV a secret, feeling bad about themselves due to their HIV status).
Measured: Enrollment to 12-weeks; 6-month follow-up
Depressive symptoms
Participants will complete the 9-item Patient Health Questionnaire (PHQ-9) to provide information about their current symptoms of depression.
Measured: Enrollment to 12-weeks; follow-up at 6-months
Coping Self-Efficacy
Participants will provide information about their coping self-efficacy, which measures their ability to cope with stress and hardship. They will complete the 26-item Coping Self-Efficacy Scale, which has a 0 to 10 Likert-type response option (i.e., 'cannot do at all' to 'certain can do').
Measured: Enrollment to 12-weeks; follow-up at 6-months
Barriers to Mental and Behavioral Health Care
Participants will answer four questions that ask about potential barriers to mental and behavioral health care. These items will ask respondents about whether they have any unmet mental and/or behavioral health needs and will allow participants to select reasons why they have not received treatment if they felt treatment was warranted.
Measured: Enrollment to 12-weeks; follow-up at 6-months
Anxiety symptoms
Participants will complete the 7-item General Anxiety Disorder (GAD-7) Questionnaire to provide information about their current symptoms of anxiety.
Measured: Enrollment to 12-weeks; follow-up at 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (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 HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sayward Harrison, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631104
- Sponsor's protocol ID
- Pro00085794
- Other IDs
- 1K01MH118073-01A1
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to risks of revealing personal identities and/or health information for a vulnerable patient population (i.e., youth living with HIV).
Publications
Miller SJ, Weaver KE, Harrison SE. A multi-informant qualitative analysis of desired features for an mHealth tool for youth living with HIV in South Carolina. J Pediatr Psychol. 2024 Sep 1;49(9):616-627. doi: 10.1093/jpepsy/jsae047.
PubMed 38976587
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the HIV Care Continuum for Youth in the Deep South Through Mobile Health Technology
- ClinicalTrials.gov ID
- NCT07631104
- Acronym / sponsor ID
- Pro00085794
- Conditions
- HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence, mHealth Application, mHealth Intervention, Continuum of Care, Youth With HIV
- Keywords
- Youth living with HIV (YLHIV), immunology, HIV, adolescents, emerging/young adults, eHealth/mHealth/digital health, adherence/self-management, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Jun 2026 (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.
Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.
Detailed description
In this study, investigators will conduct a brief pilot trial of the MindBodyU intervention--a digital health intervention that is delivered via a smartphone application ('app'). In the study, a total of 40 youth living with HIV (YLHIV) be provided with access to the MindBodyU app. Investigators will collect survey data from youth before youth install the app on their personal phone and again at 12-weeks and 6-months to assess feasibility and acceptability of the intervention, as well as preliminary outcomes (e.g., engagement/retention in care, adherence, viral suppression).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MindBodyU Intervention | Experimental | Behavioral: MindBodyU InterventionThis is a single group, one arm trial in which participants (youth living with HIV aged 16-25 years who are current residents of South Carolina) will receive access to a mobile health (mHealth) intervention called MindBodyU that is delivered via smartphone application (app) and designed to improve engagement in care, medication adherence, and psychosocial wellbeing. The intervention includes app-based learning content, daily prompts for medication adherence, appointment reminders, behavioral health symptom tracking, ability to connect with content experts, and ability to seek feedback/support from other users. Participants will be instructed to use the intervention over a 12-week period, and will complete surveys at baseline, 12-weeks, and 6-months to assess for feasibility and acceptability of the intervention, as well as participants' engagement/retention in care, adherence to antiretroviral therapy, viral suppression, and psychosocial wellbeing. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages of 16 and 25 years
- Diagnosed with HIV
- Resident of South Carolina
- Proficient in English
Key exclusion criteria (4 listed)
- Under 16 years of age or over 25 years of age
- Is not a person living with HIV
- Is not a resident of South Carolina
- Is not proficient in 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 |
|---|---|---|
| MindBodyU InterventionAlso: MindBodyU AppThe MindBodyU app is an mHealth intervention that was developed based on input from youth living with HIV, HIV providers, and community-based organizations. The app includes multiple features designed to promote HIV care engagement, medication adherence, and psychosocial wellbeing for youth living with HIV in South Carolina. Users of the app will have the opportunity to create anonymous profiles in which they can access resources related to HIV, behavioral health, sexual health, and other social determinants of health. The app also has features that enable youth to monitor and track health behaviors (e.g., appointment reminders, medication adherence), message healthcare professionals with general health questions, and engage in moderated online forums with HIV providers and other YLHIV. | Behavioural | MindBodyU Intervention |
Primary outcome
Study Retention
Time frame: From enrollment to 12-weeks
Study retention will be measured by how many participants are retained in the study at 12-weeks (i.e., complete the 12-week follow-up. Investigators will define good retention as at least 70% of participants retained in the study at 12-weeks. Study retention will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.
Acceptability of the MindBodyU Intervention
Time frame: From enrollment to 12-weeks
This outcome is acceptability of the MindBodyU Intervention, which refers to whether adolescents and young adults find the intervention to be likable, enjoyable, engaging, and culturally appropriate. Acceptability will be measured by the Acceptability of Intervention Measure (AIM), and operationalized as a mean score of 3 or more on 5-point Likert scale for the following items: 'MindBodyU meets my approval', 'MindBodyU is appealing to me', and 'I like the MindBodyU app'. It will also be measured by participant scores on the item, 'The MindBodyU app aligns with my values' and 'The MindBodyU app is a good fit for me' (i.e., score of 3 or more on 5-point Likert scale).
Adherence to Antiretroviral Therapy (ART)
Time frame: From enrollment to 12-weeks; follow-up at 6-months
This outcome assesses participants' self-reported adherence to antiretroviral therapy (ART). The outcome is measured by the following items: 1. Are you currently taking medications for HIV (also called antiretroviral therapy or ART)? (Yes, No, I Don't Know) 2. In the last 30 days, on how many days did you miss at least one dose of any of your HIV medications (ART)? I missed ______ days out of the last 30 days (0-30) 3. In the last 30 days, how often did you take your HIV medication in the way you were supposed to? (Never, Rarely, Sometimes, Usually, Almost always, Always) 4. In the last 30 days, how good a job did you do at taking HIV medication in the way you were supposed to? (Very poor, Poor, Fair, Good, Very good, Excellent)
Viral Suppression
Time frame: From enrollment to 12-weeks; follow-up at 6-months
This outcome measures participants' self-reported viral suppression. It will be measured by one item: 'To the best of your knowledge, are you currently virally suppressed? Viral suppression means that you have a viral load that is ≤ 200 copies/ml. This is also called having an 'undetectable' viral load.' (Yes, I am virally suppressed; No, I am not virally suppressed; I don't know if I am virally suppressed)
HIV Care Engagement
Time frame: From enrollment to 12-weeks; follow-up at 6-months
This outcome measures youths' engagement with their HIV care and their self-efficacy to engage in HIV care. It is measured by two survey items: 1) To the best of your knowledge, how many times have you missed a visit with your HIV care provider in the past 12 months? (Never missed a visit, Missed 1 visit, Missed 2-3 visits, Missed 4 or more visits, N/A - I haven't had any scheduled visits in the past 12 months); and 2) How sure are you that you could always schedule and keep your HIV appointments in the next year? (Very Unsure, Unsure, Neutral, Sure, Very Sure).
App engagement
Time frame: From enrollment to 12-weeks
App engagement will be measured by the percent of participants who use the app on a weekly basis across the 12-week period. Investigators will define good app engagement as at least 60% of participants having weekly active use of the app during the 12-week period. App engagement will be viewed as one aspect of feasibility of the MindBodyU intervention, which refers to whether adolescents and young adults will use the intervention in their real-world environments.
Perceived Burden of the MindBodyU App
Time frame: From enrollment to 12-weeks
This outcome measures youths' perceived burden of using the MindBodyU app. Three items will be used to measure perceived burden, and low perceived burden will be defined as a mean score of 3 or less on a 5-point Likert scale for these 3 items: 'This app fits easily into my daily routine [Reverse]', 'Using this app took too much time', and 'This app was a burden to use'.
Perceived Feasibility of the MindBodyU App
Time frame: From enrollment to 12-weeks
This outcome measures youths' perceived feasibility of the MindBodyU app. It will be measured with the 3-item Feasibility of Intervention Measure (FIM). Feasibility will be defined as a mean score of 3 or more on 5-point Likert scale for the following 3 items: 'Using MindBodyU was possible', 'Using MindBodyU was doable', and 'Using MindBodyU was easy to use'.
5 secondary outcomes
HIV Stigma
Time frame: Enrollment to 12-weeks; 6-month follow-up
Depressive symptoms
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Coping Self-Efficacy
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Barriers to Mental and Behavioral Health Care
Time frame: Enrollment to 12-weeks; follow-up at 6-months
Anxiety symptoms
Time frame: Enrollment to 12-weeks; follow-up at 6-months
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 5 Jun 2026.
- Background: PubMed 38976587Miller SJ, Weaver KE, Harrison SE. A multi-informant qualitative analysis of desired features for an mHealth tool for youth living with HIV in South Carolina. J Pediatr Psychol. 2024 Sep 1;49(9):616-627. doi: 10.1093/jpepsy/jsae047.
- Individual participant dataSharing planned: No. IPD will not be shared due to risks of revealing personal identities and/or health information for a vulnerable patient population (i.e., youth living with HIV).
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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.
Katherine Weaver, BS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindBodyU Intervention in people with HIV - Human Immunodeficiency Virus and HIV Antiretroviral Therapy (ART) Adherence, run by University of South Carolina 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 4 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: opening soon, as of the sponsor's last update on 5 Jun 2026. 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?
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?
Contact Sayward Harrison, PhD (9193237708, harri764@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Retention (time frame: From enrollment to 12-weeks). The study lists 8 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 NCT07631104, 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 5 Jun 2026.