Human Immunodeficiency VirusNCT06117163
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
A study testing Collaborative Care Model in people with Human Immunodeficiency Virus and Mental Disorder, run by University of Colorado, Denver at 1 site in Kenya.
Trial summary
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus, Mental Disorder
- What is being tested?
- Collaborative Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteKenya
- Study dates
- 1 Oct 2024to 31 May 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant woman living with HIV attending an antenatal clinic in southwestern Kenya
- screening positive for probable common mental disorders
- living in catchment area of study facility.
- on/initiating ART
- >15 years of age
Who cannot join
- imminent plans of suicide
- severe impairment due to severe mental, neurological or substance use disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute
Nairobi
Maricianah Onono, MBChB, monono@kemri-ucsf.org
Lisa Abuogi, MD, lisa.abuogi@cuanschutz.edu
About this study
Official title: Integration of a Collaborative Care Model for Mental Health Services Into HIV Care for Pregnant and Postpartum Women in Kenya (the Tunawiri Study)
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.
Read the detailed description
Common mental disorders (CMD) of depression and anxiety are prevalent and largely untreated among Kenyan pregnant and postpartum women living with HIV (PPWH). CMD lead to poor maternal and child health outcomes and contribute to lack of HIV care engagement and virologic failure in PPWH. While efficacious treatments for CMD exist, scaling treatment within routine health care in low- and middle-income (LMIC) settings will require stakeholder engagement and both effectiveness and implementation data to inform scale up and sustainability. The study team has integrated other efficacious interventions into antenatal (ANC) and HIV care in Kenya. The investigators now propose to integrate proven mental health services using a collaborative care model, combined with a low intensity evidence-based intervention (problem solving therapy), while targeting known social determinants of HIV-related health for PPWH (stigma and IPV). Building on the current multidisciplinary approach for HIV care in Kenya, the proposed Collaborative Care Model (CCM) will utilize existing peer mentor mothers, non-specialist behavioral care managers, and psychiatric nurses; and will incorporate a consultant psychiatrist into the ANC/HIV care team. Guided by the EPIS (Exploration-Preparation-Implementation-Sustainment) framework, the overall study goal is to integrate collaborative care for perinatal CMD within routine ANC/HIV services in Kenya, assess the costs and cost-effectiveness of this approach, and work with policy and decision makers to determine key considerations for scale-up. Specifically, in Aim 1, the investigators will identify contextual barriers and facilitators to refine an optimal integration model for delivering collaborative care model using multimethod data collection (focus groups with providers, in-depth interviews with key informants, and a clinic readiness checklist). A workshop with the study Advisory Board comprising of both county and national level stakeholders, will allow investigators to translate findings into a locally relevant CCM. In Aim 2, the investigators will test CCM in antenatal care for PPWH in a hybrid type 2 implementation-effectiveness trial using a stepped wedge design at 15 primary health care facilities in southwestern Kenya. The investigators will introduce CCM care for PPWH diagnosed with CMD during antenatal care. The co-primary health outcomes at 12 months postpartum will be (1) recovery from depression or anxiety symptoms in PPWH, and (2) proportion PPWH with sustained viral suppression and retention in HIV care. Key implementation outcomes are feasibility and acceptability. Finally, in Aim 3, the investigators will refine CCM implementation strategies through cost-effectiveness and dissemination research. The investigators will carry out costing and cost-effectiveness analysis and invite policy and decision-makers to participate in a nominal group technique process to elucidate factors for further scale up and sustainment of the CCM approach. Findings from this study will guide the development of a scalable model adaptable to other LMIC settings, contributing to global HIV and maternal health goals while addressing the burden of untreated CMD.
- Conditions
- Human Immunodeficiency Virus, Mental Disorder
- Being tested
- Collaborative Care Model
- Keywords
- HIV transmission, Prevention of Mother to Child Transmission, Linkage to care, Retention in care, Antiretroviral therapy adherence, Infant Health, Maternal CD4/viral loads, Early infant diagnosis, Acceptability of interventions, Vertical transmission, Mental Health, The Collaborative Care Model, Problem Solving Therapy, Stigma
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Mental Disorders, Psychological Well-Being, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care ModelBehavioural
Also called Tunawiri model
The investigators propose a CCM called Tunawiri, meaning "thrive" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression, and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Model (CCM) | Experimental | The investigators propose a CCM called Tunawiri, meaning "thrive" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication. Receives: Behavioral: Collaborative Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who recovered from probable depression at 12 months postpartum
The depression score is calculated and severity assessed through a brief screener, the Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding the score for each question (total points). A total score of 0-4 suggests none to minimal depression severity, a score of 5-9 mild depression severity, a score of 10-19 moderate depression severity, and a score of 20-27 severe depression. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N).
Measured: Baseline, 12 months postpartum
Proportion of women who recovered from probable anxiety at 12 months postpartum
The anxiety score is calculated and severity assessed through a brief screener, Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 score is obtained by adding a score for each question (total points). A total score of 0-4 suggests none to minimal anxiety severity, a score of 5-9 mild anxiety severity, a score of 10-14 moderate anxiety severity, and a score of 15-21 severe anxiety. Recovery from the anxiety of pregnant and postpartum women living with HIV will be assessed as the change of a total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) less than 10 points at 12 months postpartum (anxiety not detected and coded as N).
Measured: Baseline, 12 months postpartum
Proportion of women who recovered from probable depression and/or anxiety at 12 months postpartum
Composite variable of recovery from common mental health conditions: Out of women with depression and/or anxiety at baseline, Y=recovery if depression and anxiety are both coded as N at the follow-up point; N = if at least one of the variables (depression, anxiety) is coded as Y at the follow-up point. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N). Recovery from anxiety in pregnant and postpartum women living with HIV will be assessed as the change in total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) to less than 10 points at 12 months postpartum (anxiety not detected and coded as N).
Measured: Baseline, 12 months postpartum
Proportion of women with combined HIV care retention and treatment success outcome up to 12 months postpartum
Composite variable based on medical records: Y=if all described variables coded as Y, N=if at least one of the following variable coded as N: (1) Y=if a woman was retained in HIV care (didn't miss any HIV care appointment by 14 or more days after baseline up to 12 months postpartum), N=if a woman missed at least one HIV care appointment after baseline up to 12 months postpartum; (2) Y=woman had sustained suppressed HIV RNA (<400 copies/ml) after baseline up to 12 months postpartum, N=woman had at least one unsuppressed HIV RNA (≥400 copies/ml) during the period after baseline up to 12 months postpartum. Variables assessed through monthly abstraction of medical records among pregnant and postpartum women living with HIV between baseline and up to 12 months postpartum.
Measured: Between baseline and up to 12 months PP
Secondary outcomes (4)
Proportion of infants with low birth weight out of live births
A birth weight, measured in grams, and based on monthly abstraction of medical records, and categorized into normal weight (≥ 2500 grams at birth, coded as N) and low birth weight (<2500 grams at birth, coded as Y).
Measured: Birth
Proportion of women with preterm delivery out of live births
The proportion of women who experienced a preterm delivery based on medical records. Coded as Y if woman delivered <37 weeks of pregnancy and coded as N if delivered ≥37 weeks of pregnancy.
Measured: Birth
Infant HIV free survival
Proportion of infants alive and HIV-free at 12 months after birth. This is assessed in a brief interview and confirmed through medical records. Coded as Y if infant is alive and HIV-free at 12 months after birth, and coded as N if infant is not alive or HIV free at 12 months after birth.
Measured: Birth, 12 months
Infant retention in HIV care for infants who tested HIV+ among women completing 12 months postpartum
The proportion of infants who tested HIV-positive who remained enrolled in HIV care at 12 months, assessed in a brief interview and confirmed through medical records. Coded as Y if HIV+ infant is retained in care at 12 months after birth, and coded as N if infant is not retained in HIV care at 12 months after birth.
Measured: Birth, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Oct 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- A type 2 hybrid effectiveness-implementation trial with a stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Kenya Medical Research Institute, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Lisa Abuogi, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117163
- Sponsor's protocol ID
- 23-0498
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of a Collaborative Care Model for Mental Health Services Into HIV Care for Pregnant and Postpartum Women in Kenya (the Tunawiri Study)
- ClinicalTrials.gov ID
- NCT06117163
- Acronym / sponsor ID
- 23-0498
- Conditions
- Human Immunodeficiency Virus, Mental Disorder
- Keywords
- HIV transmission, Prevention of Mother to Child Transmission, Linkage to care, Retention in care, Antiretroviral therapy adherence, Infant Health, Maternal CD4/viral loads, Early infant diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Kenya Medical Research Institute, University of Alabama at Birmingham
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Nov 2023 (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.
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.
Detailed description
Common mental disorders (CMD) of depression and anxiety are prevalent and largely untreated among Kenyan pregnant and postpartum women living with HIV (PPWH). CMD lead to poor maternal and child health outcomes and contribute to lack of HIV care engagement and virologic failure in PPWH. While efficacious treatments for CMD exist, scaling treatment within routine health care in low- and middle-income (LMIC) settings will require stakeholder engagement and both effectiveness and implementation data to inform scale up and sustainability. The study team has integrated other efficacious interventions into antenatal (ANC) and HIV care in Kenya. The investigators now propose to integrate proven mental health services using a collaborative care model, combined with a low intensity evidence-based intervention (problem solving therapy), while targeting known social determinants of HIV-related health for PPWH (stigma and IPV). Building on the current multidisciplinary approach for HIV care in Kenya, the proposed Collaborative Care Model (CCM) will utilize existing peer mentor mothers, non-specialist behavioral care managers, and psychiatric nurses; and will incorporate a consultant psychiatrist into the ANC/HIV care team. Guided by the EPIS (Exploration-Preparation-Implementation-Sustainment) framework, the overall study goal is to integrate collaborative care for perinatal CMD within routine ANC/HIV services in Kenya, assess the costs and cost-effectiveness of this approach, and work with policy and decision makers to determine key considerations for scale-up. Specifically, in Aim 1, the investigators will identify contextual barriers and facilitators to refine an optimal integration model for delivering collaborative care model using multimethod data collection (focus groups with providers, in-depth interviews with key informants, and a clinic readiness checklist). A workshop with the study Advisory Board comprising of both county and national level stakeholders, will allow investigators to translate findings into a locally relevant CCM. In Aim 2, the investigators will test CCM in antenatal care for PPWH in a hybrid type 2 implementation-effectiveness trial using a stepped wedge design at 15 primary health care facilities in southwestern Kenya. The investigators will introduce CCM care for PPWH diagnosed with CMD during antenatal care. The co-primary health outcomes at 12 months postpartum will be (1) recovery from depression or anxiety symptoms in PPWH, and (2) proportion PPWH with sustained viral suppression and retention in HIV care. Key implementation outcomes are feasibility and acceptability. Finally, in Aim 3, the investigators will refine CCM implementation strategies through cost-effectiveness and dissemination research. The investigators will carry out costing and cost-effectiveness analysis and invite policy and decision-makers to participate in a nominal group technique process to elucidate factors for further scale up and sustainment of the CCM approach. Findings from this study will guide the development of a scalable model adaptable to other LMIC settings, contributing to global HIV and maternal health goals while addressing the burden of untreated CMD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A type 2 hybrid effectiveness-implementation trial with a stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Model (CCM) | Experimental | Behavioral: Collaborative Care ModelThe investigators propose a CCM called Tunawiri, meaning "thrive" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant woman living with HIV attending an antenatal clinic in southwestern Kenya
- screening positive for probable common mental disorders
- living in catchment area of study facility.
- on/initiating ART
- >15 years of age
Key exclusion criteria (2 listed)
- imminent plans of suicide
- severe impairment due to severe mental, neurological or substance use disorders.
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 |
|---|---|---|
| Collaborative Care ModelAlso: Tunawiri modelThe investigators propose a CCM called Tunawiri, meaning "thrive" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression, and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication. | Behavioural | Collaborative Care Model (CCM) |
Primary outcome
Proportion of women who recovered from probable depression at 12 months postpartum
Time frame: Baseline, 12 months postpartum
The depression score is calculated and severity assessed through a brief screener, the Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding the score for each question (total points). A total score of 0-4 suggests none to minimal depression severity, a score of 5-9 mild depression severity, a score of 10-19 moderate depression severity, and a score of 20-27 severe depression. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N).
Proportion of women who recovered from probable anxiety at 12 months postpartum
Time frame: Baseline, 12 months postpartum
The anxiety score is calculated and severity assessed through a brief screener, Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 score is obtained by adding a score for each question (total points). A total score of 0-4 suggests none to minimal anxiety severity, a score of 5-9 mild anxiety severity, a score of 10-14 moderate anxiety severity, and a score of 15-21 severe anxiety. Recovery from the anxiety of pregnant and postpartum women living with HIV will be assessed as the change of a total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) less than 10 points at 12 months postpartum (anxiety not detected and coded as N).
Proportion of women who recovered from probable depression and/or anxiety at 12 months postpartum
Time frame: Baseline, 12 months postpartum
Composite variable of recovery from common mental health conditions: Out of women with depression and/or anxiety at baseline, Y=recovery if depression and anxiety are both coded as N at the follow-up point; N = if at least one of the variables (depression, anxiety) is coded as Y at the follow-up point. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N). Recovery from anxiety in pregnant and postpartum women living with HIV will be assessed as the change in total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) to less than 10 points at 12 months postpartum (anxiety not detected and coded as N).
Proportion of women with combined HIV care retention and treatment success outcome up to 12 months postpartum
Time frame: Between baseline and up to 12 months PP
Composite variable based on medical records: Y=if all described variables coded as Y, N=if at least one of the following variable coded as N: (1) Y=if a woman was retained in HIV care (didn't miss any HIV care appointment by 14 or more days after baseline up to 12 months postpartum), N=if a woman missed at least one HIV care appointment after baseline up to 12 months postpartum; (2) Y=woman had sustained suppressed HIV RNA (<400 copies/ml) after baseline up to 12 months postpartum, N=woman had at least one unsuppressed HIV RNA (≥400 copies/ml) during the period after baseline up to 12 months postpartum. Variables assessed through monthly abstraction of medical records among pregnant and postpartum women living with HIV between baseline and up to 12 months postpartum.
4 secondary outcomes
Proportion of infants with low birth weight out of live births
Time frame: Birth
Proportion of women with preterm delivery out of live births
Time frame: Birth
Infant HIV free survival
Time frame: Birth, 12 months
Infant retention in HIV care for infants who tested HIV+ among women completing 12 months postpartum
Time frame: Birth, 12 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 8 Oct 2026.
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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.
Lisa Abuogi, MD, MSc principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care Model in people with Human Immunodeficiency Virus and Mental Disorder, run by University of Colorado, Denver at 1 site in Kenya.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Oct 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 Kenya. 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 Lisa Abuogi, MD,MSc (303-724-9383, lisa.abuogi@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who recovered from probable depression at 12 months postpartum (time frame: Baseline, 12 months postpartum). The study lists 4 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 8 Oct 2026.