Clinical trial NCT05609513: Integration of Hypertension Management in HIV Care in Uganda
Official title: PULESA Uganda: Strengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living With HIV-ImpLEmentation Strategies to SAve Lives
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Hypertension
Lead sponsor: Infectious Diseases Research Collaboration, Uganda
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-08
Enrollment: 48000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Population blood pressure control
timeFrame: Year 3-5
measure: Hypertension patient BP control
timeFrame: Year 3-5
Secondary outcomes:
measure: cost-effectiveness
timeFrame: Year 3-5
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Butabika
city: Kampala
country: Uganda
facility: Kawala
city: Kampala
country: Uganda
facility: Kisenyi
city: Kampala
country: Uganda
facility: Kitebi
city: Kampala
country: Uganda
facility: Komamboga
city: Kampala
country: Uganda
facility: Mengo Hospital
city: Kampala
country: Uganda
facility: Naguru
city: Kampala
country: Uganda
facility: Nsambya
city: Wakiso
country: Uganda
facility: Bweyogerere
city: Wakiso
country: Uganda
facility: Entebbe RRH
city: Wakiso
country: Uganda
facility: Kakiri
city: Wakiso
country: Uganda
facility: Kawanda
city: Wakiso
country: Uganda
facility: Nakawuka HCIII
city: Wakiso
country: Uganda
facility: Nsangi HCIII
city: Wakiso
country: Uganda
facility: Nurture Africa
city: Wakiso
country: Uganda
facility: Saidina
Study officials:
affiliation: INFECTIOUS DISEASES RESEARCH COLLABORATION
name: Fred C. Semitala, MBChB, MMED
role: PRINCIPAL_INVESTIGATOR
References: