Integration of Hypertension Management in HIV Care in Uganda

Hypertension Clinical Trial

— PULESAUganda  

Official title:

PULESA Uganda: Strengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living With HIV-ImpLEmentation Strategies to SAve Lives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609513
• Other study ID #: Mak-SOMREC-2022-420
• Secondary ID: 4UH3HL154501-03
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2023
• Source: Infectious Diseases Research Collaboration, Uganda
• Contact: Fred C. Semitala, MBChB, MMED
• Phone: +256 (0) 772524416
• Email: semitala[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. a higher resource intensive strategy to integrate hypertension care into HIV clinics in Uganda.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48000
• Est. completion date: August 31, 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1) All patients over 18 years of age receiving care at participating HIV clinics will contribute data for the effectiveness outcomes

Exclusion Criteria:

1) Patients who are not diagnosed with HIV receiving care at participating HIV clinics and are under the age of 18.

Related Conditions & MeSH terms

• HIV/AIDS
• Hypertension

Intervention

Other:
• HTN-BASIC
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-PLUS
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.

Locations

Country	Name	City	State
Uganda	Butabika	Kampala
Uganda	Kawala	Kampala
Uganda	Kisenyi	Kampala
Uganda	Kitebi	Kampala
Uganda	Komamboga	Kampala
Uganda	Mengo Hospital	Kampala
Uganda	Naguru	Kampala
Uganda	Nsambya	Kampala
Uganda	Bweyogerere	Wakiso
Uganda	Entebbe RRH	Wakiso
Uganda	Kakiri	Wakiso
Uganda	Kawanda	Wakiso
Uganda	Nakawuka HCIII	Wakiso
Uganda	Nsangi HCIII	Wakiso
Uganda	Nurture Africa	Wakiso
Uganda	Saidina	Wakiso

Sponsors (2)

Lead Sponsor	Collaborator
Infectious Diseases Research Collaboration, Uganda	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population blood pressure control	Proportion (%) of the entire clinic population in care (>18 years old) with a documented BP <140mmhg systolic AND <90mmhg diastolic.	Year 3-5
Primary	Hypertension patient BP control	Proportion (%) of patients with hypertension with a documented BP <140mmhg systolic AND <90mmhg diastolic. <140/90 mmHg	Year 3-5
Secondary	cost-effectiveness	Incremental cost per BP-controlled patient	Year 3-5