Abstract:
Background Persons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic
cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in
the HIV clinic setting is sub-optimal.
Methods EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-
component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three
sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention
will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and
adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be
change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the
intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade
categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment
goal (systolic blood pressure b130 mm Hg and non-HDL cholesterol b National Lipid Association targets).
Conclusions The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in
reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression. (Am Heart
J 2019;216:xxx.)
