HIV/AIDSPULESAUgandaNCT05609513
Integration of Hypertension Management in HIV Care in Uganda
A study testing HTN-BASIC and HTN-PLUS in people with HIV/AIDS and Hypertension, run by Infectious Diseases Research Collaboration, Uganda at 16 sites in Uganda.
Trial summary
Effective, cost-effective, scalable, sustainable, and equitable implementation strategies to improve care for people living with HIV and co-morbid hypertension in sub-Saharan Africa are urgently needed. Our study will compare the effectiveness, scalability, and cost-effectiveness of a lower-resource intensive vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Hypertension
- What is being tested?
- HTN-BASIC and HTN-PLUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87,421 participants
- Where
- 16 sitesUganda
- Study dates
- 6 Feb 2023to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1) All patients over 18 years of age receiving care at participating HIV clinics will contribute data for the effectiveness outcomes
Who cannot join
- 1) Patients who are not diagnosed with HIV receiving care at participating HIV clinics and are under the age of 18.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Uganda16 sites
Butabika
Kampala
Kawala
Kampala
Kisenyi
Kampala
Kitebi
Kampala
Komamboga
Kampala
Mengo Hospital
Kampala
Naguru
Kampala
Nsambya
Kampala
Bweyogerere
Wakiso
Entebbe RRH
Wakiso
Kakiri
Wakiso
Kawanda
Wakiso
Nakawuka HCIII
Wakiso
Nsangi HCIII
Wakiso
Nurture Africa
Wakiso
Saidina
Wakiso
About this study
Official title: PULESA Uganda: Strengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living With HIV-ImpLEmentation Strategies to SAve Lives
Effective, cost-effective, scalable, sustainable, and equitable implementation strategies to improve care for people living with HIV and co-morbid hypertension in sub-Saharan Africa are urgently needed. Our study will compare the effectiveness, scalability, and cost-effectiveness of a lower-resource intensive vs. a higher resource intensive strategy to integrate hypertension care into HIV clinics in Uganda.
Read the detailed description
Chronic HIV infection is a well-established risk factor for cardiovascular disease (CVD). In sub-Saharan Africa(SSA)-a region that may account for half of the global burden of CVD attributable to HIV-hypertension is the most important driver of CVD risk. Profound barriers to effective hypertension management exist, including limited knowledge, inconsistent BP measurement, and poor access to medications. HIV care innovations such as access to no-cost antiretroviral therapy, differentiated service delivery and use of PLHIV peers in care models may improve care of comorbid conditions such as hypertension. The overarching goal of PULESA-UGANDA study is to improve the BP treatment cascade for people living with HIV (PLHIV) in urban and peri-urban Uganda in a scalable and sustainable manner. This hybrid IS Type 3 study proposes to first explore current practice, routines, barriers, and facilitators of evidence-based BP care in HIV clinical settings in Kampala and Wakiso districts (Aim 1). Then, using a human-centered design approach, a design team of key stakeholders will use data from the formative assessment to develop a multi-component implementation strategy (HTN-PLUS) to improve uptake and adherence to evidence-based BP treatments, contextually adapted to these Ugandan HIV clinics (Sub-aim 1.1). The design team will adapt differentiated service delivery models, use of hypertensive PLHIV peer champions, and methods of BP monitoring that address specific barriers and facilitators of BP care. In a stepped-wedge cluster randomized trial of 16 clinics from Kampala and Wakiso, the investigators will determine the effectiveness of implementation strategies to improve BP cascade metrics (Aim 2). Clinics will be randomized to receive free and consistent access to diagnostic equipment and evidence-based antihypertensive drugs (HTN-BASIC) with and without the multi-component implementation strategy developed in sub-aim 1 (HTN-PLUS). The primary effectiveness outcome will be % of patients with hypertension diagnosis who are controlled (<140mmHg systolic). The investigators hypothesize that the HTN-BASIC intervention will increase control from 25% at baseline to 35%, and that HTN-PLUS will further increase control to 40%. The investigators will conduct an extensive mixed-methods process evaluation. The investigators will assess scalability as our main implementation outcome, and will also assess acceptability, adoption, and implementation climate. Finally, the investigators will evaluate the economic and financial sustainability of the integrated care strategies in a cost-effectiveness analysis from a societal perspective that will include household out-of-pocket expenditures. The primary outcome of this aim will be incremental cost per BP controlled patient. This study will provide much needed evidence to SSA government stakeholders for a strategy to preserve the health gains of HIV treatment by preventing death and disability from CVD.
Importantly, it will offer economic evidence of the scalability, sustainability, and equity of a model of HIV hypertension integration management.
- Conditions
- HIV/AIDS, Hypertension
- Being tested
- HTN-BASIC, HTN-PLUS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTN-BASICOther
The HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial.
HTN-PLUSOther
In addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well.
| Study group | Role | What they receive |
|---|---|---|
| 8 HIV clinics randomized to HTN BASIC | Experimental | The HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial. Receives: Other: HTN-BASIC |
| 8 HIV clinics randomized to HTN PLUS | Experimental | In addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well. Receives: Other: HTN-PLUS |
| Control Period for all 16 clinics | No intervention | Outcome data will be collected during the control period prior to intervention roll-out in all 16 clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population blood pressure control
Proportion (%) of the entire clinic population in care (>18 years old) with a documented BP <140mmhg systolic AND <90mmhg diastolic.
Measured: Year 3-5
Hypertension patient BP control
Proportion (%) of patients with hypertension with a documented BP <140mmhg systolic AND <90mmhg diastolic. <140/90 mmHg
Measured: Year 3-5
Secondary outcomes (1)
cost-effectiveness
Incremental cost per BP-controlled patient
Measured: Year 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start6 Feb 2023
- Primary completion5 Aug 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Parallel groups
- Model description
- This is a stepped wedge cluster randomized trial. Sixteen clinics will be randomized to the order in which they will begin intervention, with two clinics initiating the intervention every 2 months after a 2-month run-in period. Sites will be additionally randomized to receive the HTN-BASIC package only or the enhanced HTN-PLUS intervention. We will collect clinic data during the control period, run-in period and the intervention phase.
- Masking
- None (open label)
- Enrolment
- 87,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infectious Diseases Research Collaboration, Uganda
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Fred C. Semitala, MBChB, MMED, Principal investigator, INFECTIOUS DISEASES RESEARCH COLLABORATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609513
- Sponsor's protocol ID
- Mak-SOMREC-2022-420
- Other IDs
- 4UH3HL154501-03
- Acronym
- PULESAUganda
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data can be made available upon request.
Publications
Kiggundu JB, Semitala FC, Mwaka S, Muddu M, Kayima J, Mutungi G, Spiegelman D, Schwartz JI, Abdo M, Ssinabulya I, Mosepele M, Katahoire AR, Longenecker CT. Organizational Readiness and Leadership to Implement Integrated HIV-Hypertension Care at HIV Clinics in Uganda: A Prospective Single Arm Study Nested in a Stepped Wedge Cluster Randomized Trial. J Healthc Leadersh. 2026 Aug 30;18:626127. doi: 10.2147/JHL.S626127. eCollection 2026.
PubMed 42694941Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.
PubMed 42370263Longenecker CT, Kiggundu JB, Ayebare F, Muddu M, Kayima J, Mutungi G, Ssinabulya I, Schwartz JI, Spiegelman D, Tong G, Nugent R, Aifah A, Kagoya F, Cameron DB, Hutchinson B, Kamya MR, Katahoire AR, Semitala FC. Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda). BMC Health Serv Res. 2025 Aug 11;25(1):1060. doi: 10.1186/s12913-025-13281-9.
PubMed 40790739Kiggundu JB, Semitala FC, Lipoto CF, Giibwa L, Twine R, Mwaka S, Ayebare F, Kiwala C, Magambo EN, Mutungi G, Ssinabulya I, Spiegelman D, Kayima J, Muddu M, Schwartz JI, Katahoire AR, Longenecker CT. Early findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed-method study. J Int AIDS Soc. 2025 Jul;28 Suppl 3(Suppl 3):e26499. doi: 10.1002/jia2.26499.
PubMed 40622382
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULESA Uganda: Strengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living With HIV-ImpLEmentation Strategies to SAve Lives
- ClinicalTrials.gov ID
- NCT05609513
- Acronym / sponsor ID
- PULESAUganda / Mak-SOMREC-2022-420
- Conditions
- HIV/AIDS, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87,421 participants (actual)
- Lead sponsor
- Infectious Diseases Research Collaboration, UgandaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 8 Nov 2022 (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.
Effective, cost-effective, scalable, sustainable, and equitable implementation strategies to improve care for people living with HIV and co-morbid hypertension in sub-Saharan Africa are urgently needed. Our study will compare the effectiveness, scalability, and cost-effectiveness of a lower-resource intensive vs. a higher resource intensive strategy to integrate hypertension care into HIV clinics in Uganda.
Detailed description
Chronic HIV infection is a well-established risk factor for cardiovascular disease (CVD). In sub-Saharan Africa(SSA)-a region that may account for half of the global burden of CVD attributable to HIV-hypertension is the most important driver of CVD risk. Profound barriers to effective hypertension management exist, including limited knowledge, inconsistent BP measurement, and poor access to medications. HIV care innovations such as access to no-cost antiretroviral therapy, differentiated service delivery and use of PLHIV peers in care models may improve care of comorbid conditions such as hypertension. The overarching goal of PULESA-UGANDA study is to improve the BP treatment cascade for people living with HIV (PLHIV) in urban and peri-urban Uganda in a scalable and sustainable manner. This hybrid IS Type 3 study proposes to first explore current practice, routines, barriers, and facilitators of evidence-based BP care in HIV clinical settings in Kampala and Wakiso districts (Aim 1). Then, using a human-centered design approach, a design team of key stakeholders will use data from the formative assessment to develop a multi-component implementation strategy (HTN-PLUS) to improve uptake and adherence to evidence-based BP treatments, contextually adapted to these Ugandan HIV clinics (Sub-aim 1.1). The design team will adapt differentiated service delivery models, use of hypertensive PLHIV peer champions, and methods of BP monitoring that address specific barriers and facilitators of BP care. In a stepped-wedge cluster randomized trial of 16 clinics from Kampala and Wakiso, the investigators will determine the effectiveness of implementation strategies to improve BP cascade metrics (Aim 2). Clinics will be randomized to receive free and consistent access to diagnostic equipment and evidence-based antihypertensive drugs (HTN-BASIC) with and without the multi-component implementation strategy developed in sub-aim 1 (HTN-PLUS). The primary effectiveness outcome will be % of patients with hypertension diagnosis who are controlled (<140mmHg systolic). The investigators hypothesize that the HTN-BASIC intervention will increase control from 25% at baseline to 35%, and that HTN-PLUS will further increase control to 40%. The investigators will conduct an extensive mixed-methods process evaluation. The investigators will assess scalability as our main implementation outcome, and will also assess acceptability, adoption, and implementation climate. Finally, the investigators will evaluate the economic and financial sustainability of the integrated care strategies in a cost-effectiveness analysis from a societal perspective that will include household out-of-pocket expenditures. The primary outcome of this aim will be incremental cost per BP controlled patient. This study will provide much needed evidence to SSA government stakeholders for a strategy to preserve the health gains of HIV treatment by preventing death and disability from CVD.
Importantly, it will offer economic evidence of the scalability, sustainability, and equity of a model of HIV hypertension integration management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a stepped wedge cluster randomized trial. Sixteen clinics will be randomized to the order in which they will begin intervention, with two clinics initiating the intervention every 2 months after a 2-month run-in period. Sites will be additionally randomized to receive the HTN-BASIC package only or the enhanced HTN-PLUS intervention. We will collect clinic data during the control period, run-in period and the intervention phase.
| Arm | Type | Receives |
|---|---|---|
| 8 HIV clinics randomized to HTN BASIC | Experimental | Other: HTN-BASICThe HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial. |
| 8 HIV clinics randomized to HTN PLUS | Experimental | Other: HTN-PLUSIn addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well. |
| Control Period for all 16 clinics | No intervention | –Outcome data will be collected during the control period prior to intervention roll-out in all 16 clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) All patients over 18 years of age receiving care at participating HIV clinics will contribute data for the effectiveness outcomes
Key exclusion criteria (1 listed)
- 1) Patients who are not diagnosed with HIV receiving care at participating HIV clinics and are under the age of 18.
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 |
|---|---|---|
| HTN-BASICThe HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial. | Other | 8 HIV clinics randomized to HTN BASIC |
| HTN-PLUSIn addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well. | Other | 8 HIV clinics randomized to HTN PLUS |
Primary outcome
Population blood pressure control
Time frame: Year 3-5
Proportion (%) of the entire clinic population in care (>18 years old) with a documented BP <140mmhg systolic AND <90mmhg diastolic.
Hypertension patient BP control
Time frame: Year 3-5
Proportion (%) of patients with hypertension with a documented BP <140mmhg systolic AND <90mmhg diastolic. <140/90 mmHg
1 secondary outcome
cost-effectiveness
Time frame: Year 3-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 42694941Kiggundu JB, Semitala FC, Mwaka S, Muddu M, Kayima J, Mutungi G, Spiegelman D, Schwartz JI, Abdo M, Ssinabulya I, Mosepele M, Katahoire AR, Longenecker CT. Organizational Readiness and Leadership to Implement Integrated HIV-Hypertension Care at HIV Clinics in Uganda: A Prospective Single Arm Study Nested in a Stepped Wedge Cluster Randomized Trial. J Healthc Leadersh. 2026 Aug 30;18:626127. doi: 10.2147/JHL.S626127. eCollection 2026.
- Derived from this study: PubMed 42370263Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.
- Derived from this study: PubMed 40790739Longenecker CT, Kiggundu JB, Ayebare F, Muddu M, Kayima J, Mutungi G, Ssinabulya I, Schwartz JI, Spiegelman D, Tong G, Nugent R, Aifah A, Kagoya F, Cameron DB, Hutchinson B, Kamya MR, Katahoire AR, Semitala FC. Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda). BMC Health Serv Res. 2025 Aug 11;25(1):1060. doi: 10.1186/s12913-025-13281-9.
- Derived from this study: PubMed 40622382Kiggundu JB, Semitala FC, Lipoto CF, Giibwa L, Twine R, Mwaka S, Ayebare F, Kiwala C, Magambo EN, Mutungi G, Ssinabulya I, Spiegelman D, Kayima J, Muddu M, Schwartz JI, Katahoire AR, Longenecker CT. Early findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed-method study. J Int AIDS Soc. 2025 Jul;28 Suppl 3(Suppl 3):e26499. doi: 10.1002/jia2.26499.
- Individual participant dataSharing planned: Yes. De-identified data can be made available upon request.
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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. This study is not recruiting at the moment.
Fred C. Semitala, MBChB, MMED principal investigator
INFECTIOUS DISEASES RESEARCH COLLABORATION
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTN-BASIC and HTN-PLUS in people with HIV/AIDS and Hypertension, run by Infectious Diseases Research Collaboration, Uganda at 16 sites in Uganda.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population blood pressure control (time frame: Year 3-5). The study lists 2 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 NCT05609513, which also lists 4 linked publications.
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 23 Jul 2026.