Psychotic DisordersVVV RCTNCT07555275
Testing a Peer-Support Group for Veterans Who Hear Voices
A study testing Veteran Voices and Visions (VVV) and Wellness Recovery Action Planning (WRAP) in people with Psychotic Disorders and Hallucinations, Auditory, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Hallucinations, Auditory, Social Isolation
- What is being tested?
- Veteran Voices and Visions (VVV) and Wellness Recovery Action Planning (WRAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2027to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use
- English fluency sufficient for participating in groups
- Able to provide consent
Who cannot join
- Psychosis exclusively due to substance use
- Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder/intellectual disability
- Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney
- Plan to transfer or terminate care in the next 3 months
- Has previously attended a VVV group
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Matthew Chinman, PhD, 412-683-2300 ext. 4287, chinman@rand.org
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Ippolytos A Kalofonos, MD PhD MPH, 310-478-3711 ext. 83254, Ippolytos.Kalofonos@va.gov
Ippolytos A Kalofonos, MD PhD MPH
About this study
Official title: A Multisited Efficacy Trial of Veteran Voices and Visions
Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.
Read the detailed description
Veterans have a higher prevalence than non-Veterans of Schizophrenia-spectrum disorders (SSD). These Veterans often struggle with social integration-e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. They are at high risk of homelessness and suicide, and the impact on overall mortality is comparable to that of smoking and greater than obesity and alcohol abuse. SSD diagnoses are a significant cause of disability and a drain on VA resources. Auditory hallucinations (AH) are particularly linked to social withdrawal. Stigma against voice-hearing leads to silence, internalized shame, and social isolation, fueling cycles of avoidance and distress. Veteran Voices and Visions (VVV) is a psychosocial group intervention for Veterans with psychosis based on the Hearing Voices (HV) approach that reduces distress related to psychosis and builds a sense of belonging for Veterans living with psychosis. This intervention is hypothesized to increase social integration.
VVV takes a recovery-oriented, peer-led, Veteran-centered approach to understanding and reframing psychosis that emphasizes personal meaning and destigmatization. Pilot data indicates the approach reduces distress due to AH and fosters a sense of belonging. Research with Veterans with Serious Mental Illness (SMI) shows a high sense of belonging is protective against suicidal ideation. The proposed study would be the first ever to test the efficacy of a HV-inspired approach. If successful, it could transform how VA addresses psychosis by mobilizing the peer workforce to the benefit of a vulnerable group of Veterans.
Specific Aims: Aim 1: Assess VVV efficacy: At each site, 80 Veterans will be randomly assigned to receive 12 weeks of VVV or a Wellness Recovery Action Planning (WRAP) group. Facilitators will be regularly supervised, and group sessions will be video recorded for fidelity review. Veterans will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks) on the proximal outcomes of distress related to AH and sense of belonging, and distal outcome of social functioning. Secondary outcomes include severity of symptoms, self-efficacy, subjective recovery, self-stigma, loneliness, and hope.
Hypothesis: Veterans in VVV will have reduced distress due to AH and increased sense of belonging relative to Veterans in WRAP at the end of the intervention, and they will have increased social functioning at 24-week follow up.
Aim 2: Identify contextual factors that support or impede VVV implementation in the context of routine care. The investigators will use the updated Consolidation Framework for Implementation Research (CFIR) to guide interviews with VVV facilitators, and local and national mental health leadership. The investigators will use rapid analysis on the resulting qualitative data to assess the context to support implementation of VVV (if effective).
Methodology: This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across 2 VA sites.
Path to Translation/Implementation: A hybrid 1 trial is when an intervention is tested for effectiveness while collecting implementation data that could inform future delivery in real-world settings. Adding implementation assessments is a modest investment that does not impede the full test of an intervention's effectiveness and speeds the pace of the research pipeline, which often moves evidence-based practices (EBPs) into real-world settings much too slowly. The next step could be an implementation-focused trial.
- Being tested
- Veteran Voices and Visions (VVV), Wellness Recovery Action Planning (WRAP)
- Keywords
- Psychotic Disorders, hallucinations, auditory, social isolation, Veterans
- Medical subject headings
- Psychotic Disorders, Hallucinations, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veteran Voices and Visions (VVV)Behavioural
Also called VVV
This is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation.
Wellness Recovery Action Planning (WRAP)Behavioural
Also called WRAP
Wellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Veteran Voices and Visions (VVV) | Experimental | This is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with serious mental illness (SMI), called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation. Receives: Behavioral: Veteran Voices and Visions (VVV) |
| Wellness Recovery Action Planning (WRAP) | Active comparator | Wellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis. Receives: Behavioral: Wellness Recovery Action Planning (WRAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH)
PSYRATS-AH is an 11-item subscale assessing frequency, duration, severity, loudness, location, negative content, controllability of voices, intensity of distress, beliefs about origin of voices, and disruption. Items are rated on a five-point ordinal scale (0-4), range is 0 to 44. Higher score means worse distress. PSYRATS has strong inter-rater reliability (r ⩾ 0.9), test-retest reliability (0.55-0.74), and good validity (0.63-0.76). It is the gold standard for assessment of AH and the main finding from the initial VVV pilot study.
Measured: 12 and 24 weeks
The Sense of Belonging Inventory-Psychological Experiences (SOBI-P)
The SOBI-P is a reliable measure of belonging that consists of 18 items on a 4-point Likert response scale and it is used widely in SSD.
Measured: 12 and 24 weeks
The Role Functioning Scale (RFS)
This is a distal primary outcome. The Role Functioning Scale (RFS) is a broad global integration index across the domains of work, independent living, and family/social networks that ranges from 1 (worst) to 7 (best). It has established reliability and validity in Schizophrenia Spectrum Disorders. The total score for the RFS is calculated by summing the subscales, resulting in a range of 0-28, where higher scores indicate better functioning.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Apr 2027 (estimated)
- Primary completion29 Mar 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across two sites. A hybrid 1 trial is when an intervention is tested for efficacy while collecting implementation data that could inform future delivery in real-world settings.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Pittsburgh Healthcare System
- Responsible party
- Sponsor
- Investigators
- Ippolytos A Kalofonos, MD PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAMatthew J Chinman, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555275
- Sponsor's protocol ID
- RRD4-007-25M
- Other IDs
- 1I01RD000538-01A2
- Acronym
- VVV RCT
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will create de-identified, study-specific datasets that include all variables in a publication. Some loss of information might occur given the need to remove protected health information (PHI). The PI will replace social security and medical station numbers with study-specific numbers. The PI will drop date of birth and replace age with age categories, in accordance with PHI requirements for people 85 years of age and older. Dates of service will be replaced with year dummies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisited Efficacy Trial of Veteran Voices and Visions
- ClinicalTrials.gov ID
- NCT07555275
- Acronym / sponsor ID
- VVV RCT / RRD4-007-25M
- Keywords
- Psychotic Disorders, hallucinations, auditory, social isolation, Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Pittsburgh Healthcare System
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 29 Mar 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 29 Apr 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.
Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.
Detailed description
Veterans have a higher prevalence than non-Veterans of Schizophrenia-spectrum disorders (SSD). These Veterans often struggle with social integration-e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. They are at high risk of homelessness and suicide, and the impact on overall mortality is comparable to that of smoking and greater than obesity and alcohol abuse. SSD diagnoses are a significant cause of disability and a drain on VA resources. Auditory hallucinations (AH) are particularly linked to social withdrawal. Stigma against voice-hearing leads to silence, internalized shame, and social isolation, fueling cycles of avoidance and distress. Veteran Voices and Visions (VVV) is a psychosocial group intervention for Veterans with psychosis based on the Hearing Voices (HV) approach that reduces distress related to psychosis and builds a sense of belonging for Veterans living with psychosis. This intervention is hypothesized to increase social integration.
VVV takes a recovery-oriented, peer-led, Veteran-centered approach to understanding and reframing psychosis that emphasizes personal meaning and destigmatization. Pilot data indicates the approach reduces distress due to AH and fosters a sense of belonging. Research with Veterans with Serious Mental Illness (SMI) shows a high sense of belonging is protective against suicidal ideation. The proposed study would be the first ever to test the efficacy of a HV-inspired approach. If successful, it could transform how VA addresses psychosis by mobilizing the peer workforce to the benefit of a vulnerable group of Veterans.
Specific Aims: Aim 1: Assess VVV efficacy: At each site, 80 Veterans will be randomly assigned to receive 12 weeks of VVV or a Wellness Recovery Action Planning (WRAP) group. Facilitators will be regularly supervised, and group sessions will be video recorded for fidelity review. Veterans will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks) on the proximal outcomes of distress related to AH and sense of belonging, and distal outcome of social functioning. Secondary outcomes include severity of symptoms, self-efficacy, subjective recovery, self-stigma, loneliness, and hope.
Hypothesis: Veterans in VVV will have reduced distress due to AH and increased sense of belonging relative to Veterans in WRAP at the end of the intervention, and they will have increased social functioning at 24-week follow up.
Aim 2: Identify contextual factors that support or impede VVV implementation in the context of routine care. The investigators will use the updated Consolidation Framework for Implementation Research (CFIR) to guide interviews with VVV facilitators, and local and national mental health leadership. The investigators will use rapid analysis on the resulting qualitative data to assess the context to support implementation of VVV (if effective).
Methodology: This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across 2 VA sites.
Path to Translation/Implementation: A hybrid 1 trial is when an intervention is tested for effectiveness while collecting implementation data that could inform future delivery in real-world settings. Adding implementation assessments is a modest investment that does not impede the full test of an intervention's effectiveness and speeds the pace of the research pipeline, which often moves evidence-based practices (EBPs) into real-world settings much too slowly. The next step could be an implementation-focused trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across two sites. A hybrid 1 trial is when an intervention is tested for efficacy while collecting implementation data that could inform future delivery in real-world settings.
| Arm | Type | Receives |
|---|---|---|
| Veteran Voices and Visions (VVV) | Experimental | Behavioral: Veteran Voices and Visions (VVV)This is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with serious mental illness (SMI), called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation. |
| Wellness Recovery Action Planning (WRAP) | Active comparator | Behavioral: Wellness Recovery Action Planning (WRAP)Wellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use
- English fluency sufficient for participating in groups
- Able to provide consent
Key exclusion criteria (5 listed)
- Psychosis exclusively due to substance use
- Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder/intellectual disability
- Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney
- Plan to transfer or terminate care in the next 3 months
- Has previously attended a VVV group
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 |
|---|---|---|
| Veteran Voices and Visions (VVV)Also: VVVThis is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation. | Behavioural | Veteran Voices and Visions (VVV) |
| Wellness Recovery Action Planning (WRAP)Also: WRAPWellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis. | Behavioural | Wellness Recovery Action Planning (WRAP) |
Primary outcome
Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH)
Time frame: 12 and 24 weeks
PSYRATS-AH is an 11-item subscale assessing frequency, duration, severity, loudness, location, negative content, controllability of voices, intensity of distress, beliefs about origin of voices, and disruption. Items are rated on a five-point ordinal scale (0-4), range is 0 to 44. Higher score means worse distress. PSYRATS has strong inter-rater reliability (r ⩾ 0.9), test-retest reliability (0.55-0.74), and good validity (0.63-0.76). It is the gold standard for assessment of AH and the main finding from the initial VVV pilot study.
The Sense of Belonging Inventory-Psychological Experiences (SOBI-P)
Time frame: 12 and 24 weeks
The SOBI-P is a reliable measure of belonging that consists of 18 items on a 4-point Likert response scale and it is used widely in SSD.
The Role Functioning Scale (RFS)
Time frame: 12 and 24 weeks
This is a distal primary outcome. The Role Functioning Scale (RFS) is a broad global integration index across the domains of work, independent living, and family/social networks that ranges from 1 (worst) to 7 (best). It has established reliability and validity in Schizophrenia Spectrum Disorders. The total score for the RFS is calculated by summing the subscales, resulting in a range of 0-28, where higher scores indicate better functioning.
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. The PI will create de-identified, study-specific datasets that include all variables in a publication. Some loss of information might occur given the need to remove protected health information (PHI). The PI will replace social security and medical station numbers with study-specific numbers. The PI will drop date of birth and replace age with age categories, in accordance with PHI requirements for people 85 years of age and older. Dates of service will be replaced with year dummies.
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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.
Ippolytos A Kalofonos, MD PhD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Matthew J Chinman, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veteran Voices and Visions (VVV) and Wellness Recovery Action Planning (WRAP) in people with Psychotic Disorders and Hallucinations, Auditory, run by VA Office of Research and Development at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ippolytos A Kalofonos, MD PhD MPH ((310) 478-3711 ext. 83254, Ippolytos.Kalofonos@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH) (time frame: 12 and 24 weeks). The study lists 3 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 29 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.