PregnancySPHERESNCT07126041
Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)
A study testing Prescription for Action (SPHERES Model) in people with Pregnancy and Neonatal Mortality, run by Oxford University Clinical Research Unit Indonesia at 2 sites in Indonesia.
Trial summary
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Neonatal Mortality, Tuberculosis
- What is being tested?
- Prescription for Action (SPHERES Model)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750,000 participants
- Where
- 2 sitesIndonesia
- Study dates
- 14 Aug 2025to 31 Mar 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residing in or participating in the district catchment areas
- Receiving services from participating health care facilities
- Health providers and district health officials consent to participate in data collection
Who cannot join
- Individuals (health workers or patients) who decline to provide informed consent.
- Individuals who are not directly involved in or accessing services from health care facilities or district health offices.
- Inability to provide consent due to cognitive impairment or acute illness for health workers or district health officials involved in data collection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites
West Lombok District Health Office
Gerung, West Nusa Tenggara
Zulkipli Zulkipli, Ns, MM, +6287865857791, zulkifligunungsari.1@gmail.com
Zulkipli Zulkipli, Ns, MM
Purbalingga District Health Office
Purbalingga, Central Java
Jusi Febrianto, MD, MPH, +628156704738, rbdpn2001@yahoo.co.id
Jusi Febrianto, MD, MPH
About this study
Official title: End-to-end Digital Transformation for Primary Health Care Performance Management Via Scalable Public Health Empowerment, Research, and Education Sites: A Stepped-Wedge Cluster Randomized Trial
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious, and non-communicable disease programs.
Read the detailed description
The SPHERES (Scalable Public Health Empowerment, Research and Education Sites) study is a stepped-wedge health service research trial designed to assess the impact of a complex intervention to enhance the performance of Indonesia's primary health care system through an integrated package of digital health tools to enhance data interoperability, human resource and performance improvement, data-driven decision-making, and changes in work culture toward information-based decision-making, actions, and accountability. The central innovation lies in the "prescription for action" approach, wherein district health managers and heads of primary healthcare centers (PHC) create structured monthly prescriptions that describe actions to be taken to improve primary health care informed by real-time health data visualized on interactive dashboards. These prescriptions are tailored to address gap in priority service delivery challenges including gaps in preventive and promotive care - such as low coverage or quality of antenatal, intrapartum, or postnatal care, or missed opportunities for hepatitis B prevention in pregnancy, or gaps in overall diagnosis and treatment of tuberculosis, or gaps in overall screening and diagnosis and treatment of hypertension or diabetes, - and are grounded in both epidemiological insight and health systems analysis.
As a cluster-randomized stepped-wedge health service trial in the Indonesian primary care system, SPHERES involve multiple primary healthcare centers (PHCs) as the unit of intervention across two districts: West Lombok (West Nusa Tenggara Province) and Purbalingga (Central Java Province). At regular intervals (approximately every 4 months), new clusters (approximately 25% of the total number of PHCs in the district) are transitioned from control to intervention status, until all sites receive the SPHERES intervention within 16 months. This phased approach allows for rigorous evaluation while ensuring equitable access to the program. The intervention package includes: (1) establishment of Public Health Data Theaters as training centers for the active use of data for decision-making using interactive dynamic dashboards, public health data rounds, prescriptions for action for precision public health, digital report cards, and team-based care, (2) deployment of Sustainable Scaling Teams to engage districts in developing the essential technical and management skills for digital ecosystems, and (3) establish ecosystems of interoperable data at the district level to support curative, preventive, and promotive care delivery by frontline health workers. Thus, the intervention will be implemented over 16 months, with approximately 25% of PHCs transitioning every quarter from control to intervention in monthly waves, starting August 2025, with all PHCs receiving the intervention by August 2026.
To support high-fidelity implementation, at each phase of the stepped-wedge, each cluster undergoes a two-phase transformation, a pre-intervention digital readiness phase, followed by the intervention interventions, i.e. the "prescriptions for action" phase. The preparatory step focuses on strengthening digital infrastructure and practices at the PHC level, including standardizing electronic health record inputs, and ensuring interoperability across digital health platforms. Sequencing this digitalization phase ahead of the "prescriptions for action" phase enhances the fidelity and compliance for managerial and behavioral actions that may be included within the "prescriptions for action" intervention.
SPHERES targets improvements in coverage, quality, and outcomes across three priority domains: maternal and child health (including immunization and stunting), infectious disease (tuberculosis and hepatitis B), and non-communicable diseases (diabetes and hypertension). The study will assess impacts on service uptake (e.g., ANC 6 coverage, quality of care, diabetes screening), clinical outcomes (e.g., neonatal mortality, TB treatment success, Hepatitis B vertical transmission), and system-level indicators (e.g., prescription compliance, data use in decision-making). Embedded within the project is a robust capacity-building component for health workers and program managers, along with qualitative assessments of acceptability, feasibility, and perceived value.
SPHERES is expected to produce evidence for improving PHC service quality and responsiveness across Indonesia. By combining routine data analytics with a structured decision-support mechanism, the intervention aims to institutionalize active data use at the district level. Findings from SPHERES are expected to inform Indonesia's Ministry of Health Digital Roadmap and broader digital health transformation strategy and offer generalizable insights into how data empowerment combined with human resource management and change in work culture can drive system-wide improvements in low- and middle-income countries.
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B, Hypertension, Diabetes Mellitus
- Being tested
- Prescription for Action (SPHERES Model)
- Keywords
- Primary health care performance, Digital health transformation, Maternal health, Child health, Immunization, Stunting, Tuberculosis, Hepatitis B, Diabetes mellitus, Hypertension, Health system strengthening, Indonesia, Health governance, Human resource management, Work culture
- Medical subject headings
- Tuberculosis, Hepatitis B, Hypertension, Diabetes Mellitus, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription for Action (SPHERES Model)Other
A system-level intervention consisting of:
- a digital dashboard displaying local health services, outcome indicators, and operational data in a secure Public Health Data Theater;
- structured monthly prescription guides targeting service improvements across three priority program areas;
- monthly performance monitoring with district health leaders. The intervention is applied at the PHC level, all supported by digital capacity building, district-level deployment of implementation teams, and intersectoral secure health data exchange.
| Study group | Role | What they receive |
|---|---|---|
| SPHERES Intervention Arm | Experimental | Participants (district populations) receive services improved by the SPHERES model, which includes structured prescription-for-action protocols targeting three priority domains (infectious disease, maternal \& child health, and non-communicable diseases). Receives: Other: Prescription for Action (SPHERES Model) |
| Control | No intervention | Standard of care are expected at primary health centers before the SPHERES intervention is deployed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in neonatal mortality rate between intervention and control periods
Neonatal mortality per 1,000 live births, calculated using health facility and civil registration data, and community household sampling surveys
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Secondary outcomes (7)
Difference in complete antenatal care (ANC 6) visit coverage between intervention and control periods
Percentage of pregnant women completing ≥6 ANC visits calculated using health facility data, paper based registry, and/or community household sampling surveys
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in complete basic childhood immunization coverage between the intervention and control period
Proportion of children aged 12-23 months receiving all recommended basic childhood vaccines according to Indonesian Pediatric Society guidelines using health facility data, paper based registry, and/or community household sampling surveys
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in TB treatment success rate between intervention and control periods
Percentage of new bacteriologically confirmed TB patients with documented treatment success (cure or completion) calculated using health facility data
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in screening coverage for diabetes mellitus among adults between the intervention and control periods
Proportion of adults aged ≥40 screened for random blood glucose or fasting blood glucose calculated using health facility data
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in the rate of vertical transmission of hepatitis B between intervention and control periods
Proportion of infants born to hepatitis B surface antigen (HBsAg)-positive mothers who test positive for HBsAg at 9 to 12 months of age. Data will be collected to evaluate the effectiveness of Tenofovir initiation, timely birth dose, routine childhood Hepatitis B vaccination, and HBIG administration as part of the vertical transmission prevention protocol.
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in the uptake of dashboard use among district health managers and heads of PHC
Proportion of monthly coordination meetings in which district health managers and heads of PHC accessed and used the SPHERES digital dashboard to review performance data and guide decision-making. Usage will be measured through system access logs and meeting documentation.
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in prescription-for-action implementation rate at the PHC
Proportion of prescriptions-for-action issued during Public Health Data Theater sessions that are completed by PHCs within one month. Data will be collected from district monitoring reports and PHC-level follow-up documentation.
Measured: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start14 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study follows a stepped-wedge cluster randomized design in which primary health centers (PHCs) are randomized to receive the intervention in phased steps over time/sequentially. Each cohort enters a digital readiness of up to two months before transitioning into the full SPHERES intervention. Transitions to a new sets of clusters would occur approximately every four months, with full coverage expected within sixteen months of study start.
- Masking
- None (open label)
- Enrolment
- 1,750,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Summit Institute for Development, Indonesia
- Responsible party
- Principal investigator, Anuraj Shankar, Oxford University Clinical Research Unit Indonesia
- Investigators
- Anuraj H Shankar, D. Sc., Principal investigator, Oxford University Clinical Research Unit Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126041
- Sponsor's protocol ID
- OUCRU-ID.2025.002
- Other IDs
- Grant Number : INV-070822
- Acronym
- SPHERES
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will not share individual participant data due to the population-level nature of the intervention and national data privacy regulations. Only aggregated and de-identified/anonymized data and codebook may be made publicly available upon publication. All data collection, storage, and analysis procedures will comply with Indonesia's Personal Data Protection Law (UU PDP), Ministry of Health guidance, and institutional ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-to-end Digital Transformation for Primary Health Care Performance Management Via Scalable Public Health Empowerment, Research, and Education Sites: A Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07126041
- Acronym / sponsor ID
- SPHERES / OUCRU-ID.2025.002
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B, Hypertension, Diabetes Mellitus
- Keywords
- Primary health care performance, Digital health transformation, Maternal health, Child health, Immunization, Stunting, Tuberculosis, Hepatitis B
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,750,000 participants (estimated)
- Lead sponsor
- Oxford University Clinical Research Unit IndonesiaUniversity, hospital or other
- Collaborators
- Summit Institute for Development, Indonesia
- Study start
- 14 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious, and non-communicable disease programs.
Detailed description
The SPHERES (Scalable Public Health Empowerment, Research and Education Sites) study is a stepped-wedge health service research trial designed to assess the impact of a complex intervention to enhance the performance of Indonesia's primary health care system through an integrated package of digital health tools to enhance data interoperability, human resource and performance improvement, data-driven decision-making, and changes in work culture toward information-based decision-making, actions, and accountability. The central innovation lies in the "prescription for action" approach, wherein district health managers and heads of primary healthcare centers (PHC) create structured monthly prescriptions that describe actions to be taken to improve primary health care informed by real-time health data visualized on interactive dashboards. These prescriptions are tailored to address gap in priority service delivery challenges including gaps in preventive and promotive care - such as low coverage or quality of antenatal, intrapartum, or postnatal care, or missed opportunities for hepatitis B prevention in pregnancy, or gaps in overall diagnosis and treatment of tuberculosis, or gaps in overall screening and diagnosis and treatment of hypertension or diabetes, - and are grounded in both epidemiological insight and health systems analysis.
As a cluster-randomized stepped-wedge health service trial in the Indonesian primary care system, SPHERES involve multiple primary healthcare centers (PHCs) as the unit of intervention across two districts: West Lombok (West Nusa Tenggara Province) and Purbalingga (Central Java Province). At regular intervals (approximately every 4 months), new clusters (approximately 25% of the total number of PHCs in the district) are transitioned from control to intervention status, until all sites receive the SPHERES intervention within 16 months. This phased approach allows for rigorous evaluation while ensuring equitable access to the program. The intervention package includes: (1) establishment of Public Health Data Theaters as training centers for the active use of data for decision-making using interactive dynamic dashboards, public health data rounds, prescriptions for action for precision public health, digital report cards, and team-based care, (2) deployment of Sustainable Scaling Teams to engage districts in developing the essential technical and management skills for digital ecosystems, and (3) establish ecosystems of interoperable data at the district level to support curative, preventive, and promotive care delivery by frontline health workers. Thus, the intervention will be implemented over 16 months, with approximately 25% of PHCs transitioning every quarter from control to intervention in monthly waves, starting August 2025, with all PHCs receiving the intervention by August 2026.
To support high-fidelity implementation, at each phase of the stepped-wedge, each cluster undergoes a two-phase transformation, a pre-intervention digital readiness phase, followed by the intervention interventions, i.e. the "prescriptions for action" phase. The preparatory step focuses on strengthening digital infrastructure and practices at the PHC level, including standardizing electronic health record inputs, and ensuring interoperability across digital health platforms. Sequencing this digitalization phase ahead of the "prescriptions for action" phase enhances the fidelity and compliance for managerial and behavioral actions that may be included within the "prescriptions for action" intervention.
SPHERES targets improvements in coverage, quality, and outcomes across three priority domains: maternal and child health (including immunization and stunting), infectious disease (tuberculosis and hepatitis B), and non-communicable diseases (diabetes and hypertension). The study will assess impacts on service uptake (e.g., ANC 6 coverage, quality of care, diabetes screening), clinical outcomes (e.g., neonatal mortality, TB treatment success, Hepatitis B vertical transmission), and system-level indicators (e.g., prescription compliance, data use in decision-making). Embedded within the project is a robust capacity-building component for health workers and program managers, along with qualitative assessments of acceptability, feasibility, and perceived value.
SPHERES is expected to produce evidence for improving PHC service quality and responsiveness across Indonesia. By combining routine data analytics with a structured decision-support mechanism, the intervention aims to institutionalize active data use at the district level. Findings from SPHERES are expected to inform Indonesia's Ministry of Health Digital Roadmap and broader digital health transformation strategy and offer generalizable insights into how data empowerment combined with human resource management and change in work culture can drive system-wide improvements in low- and middle-income countries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study follows a stepped-wedge cluster randomized design in which primary health centers (PHCs) are randomized to receive the intervention in phased steps over time/sequentially. Each cohort enters a digital readiness of up to two months before transitioning into the full SPHERES intervention. Transitions to a new sets of clusters would occur approximately every four months, with full coverage expected within sixteen months of study start.
| Arm | Type | Receives |
|---|---|---|
| SPHERES Intervention Arm | Experimental | Other: Prescription for Action (SPHERES Model)Participants (district populations) receive services improved by the SPHERES model, which includes structured prescription-for-action protocols targeting three priority domains (infectious disease, maternal \& child health, and non-communicable diseases). |
| Control | No intervention | –Standard of care are expected at primary health centers before the SPHERES intervention is deployed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Residing in or participating in the district catchment areas
- Receiving services from participating health care facilities
- Health providers and district health officials consent to participate in data collection
Key exclusion criteria (3 listed)
- Individuals (health workers or patients) who decline to provide informed consent.
- Individuals who are not directly involved in or accessing services from health care facilities or district health offices.
- Inability to provide consent due to cognitive impairment or acute illness for health workers or district health officials involved in data collection
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 |
|---|---|---|
| Prescription for Action (SPHERES Model)A system-level intervention consisting of: * a digital dashboard displaying local health services, outcome indicators, and operational data in a secure Public Health Data Theater; * structured monthly prescription guides targeting service improvements across three priority program areas; * monthly performance monitoring with district health leaders. The intervention is applied at the PHC level, all supported by digital capacity building, district-level deployment of implementation teams, and intersectoral secure health data exchange. | Other | SPHERES Intervention Arm |
Primary outcome
Difference in neonatal mortality rate between intervention and control periods
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Neonatal mortality per 1,000 live births, calculated using health facility and civil registration data, and community household sampling surveys
7 secondary outcomes
Difference in complete antenatal care (ANC 6) visit coverage between intervention and control periods
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in complete basic childhood immunization coverage between the intervention and control period
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in TB treatment success rate between intervention and control periods
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in screening coverage for diabetes mellitus among adults between the intervention and control periods
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in the rate of vertical transmission of hepatitis B between intervention and control periods
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in the uptake of dashboard use among district health managers and heads of PHC
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
Difference in prescription-for-action implementation rate at the PHC
Time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)
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 15 Aug 2025.
- Official project website for SPHERES, providing information on project background, implementation framework, partnerships, project status, and the investigators involved.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study will not share individual participant data due to the population-level nature of the intervention and national data privacy regulations. Only aggregated and de-identified/anonymized data and codebook may be made publicly available upon publication. All data collection, storage, and analysis procedures will comply with Indonesia's Personal Data Protection Law (UU PDP), Ministry of Health guidance, and institutional ethical standards.
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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.
Anuraj H Shankar, D. Sc. principal investigator
Oxford University Clinical Research Unit Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription for Action (SPHERES Model) in people with Pregnancy and Neonatal Mortality, run by Oxford University Clinical Research Unit Indonesia at 2 sites in Indonesia.
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 3 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 15 Aug 2025. 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 Indonesia. 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 Zamzam Noerzen Djaelani, MD, MBA (+6281385680388, zdjaelani@oucru.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in neonatal mortality rate between intervention and control periods (time frame: Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)). 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 15 Aug 2025.