Chronic HIV infection is a well-established risk factor for cardiovascular disease. In sub-Saharan Africa)?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, we 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). We 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%. We will conduct an extensive mixed-methods process evaluation. We will assess scalability as our main implementation outcome, and will also assess acceptability, adoption, and implementation climate. Finally, we 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 management integration.
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.
