Evaluation of Vascular Event Risk while on Long-term Anti-retroviral Suppressive Therapy [EVERLAST]: Protocol for a prospective observational study

Abstract

Background & objective: Cardiovascular disease (CVD) risk among the HIV population is high due to a combination of accelerated atherosclerosis from the pro-inflammatory milieu created by chronic HIV infection and the potentially adverse metabolic side effects from cART (combination antiretroviral therapy) medications. Although sub-Saharan Africa (SSA) bears 70% of the global burden of HIV disease, there is a relative paucity of studies comprehensively assessing CVD risk among people living with HIV on the continent. The overarching objective of the Evaluation of Vascular Event Risk while on Long-term Anti-retroviral Suppressive Therapy (EVERLAST) Study is to characterize the burden of CVD among HIV patients on ART in Ghana, and explore factors influencing it. Methods: The EVERLAST study incorporates prospective CVD risk assessments and a convergent mixed methods approach. This prospective study will evaluate CVD risk by measuring Carotid Intimal Media Thickness (CIMT) and presence of traditional medical and lifestyle vascular risk among 240 Ghanaian HIV patients on antiretroviral therapy compared with age- and sex-matched HIV uninfected (n = 240) and HIV positive ART naïve controls (n = 240). A contextual qualitative analysis will also be conducted to determine attitudes/perceptions of various key local stakeholders about CVD risk among HIV patients. The primary outcome measure will be CIMT measured cross-sectionally and prospectively among the three groups. A host of secondary outcome variables including CVD risk factors, CVD risk equations, HIV associated neurocognitive dysfunction and psychological well-being will also be assessed. Conclusion: EVERLAST will provide crucial insights into the unique contributions of ART exposure and environmental factors such as lifestyle, traditional beliefs, and socio-economic indicators to CVD risk among HIV patients in a resource-limited setting. Ultimately, findings from our study will be utilized to develop interventions that will be tested in a randomized controlled trial to provide evidence to guide CVD risk management in SSA. Keywords: HIV, Cardiovascular risk, Stroke, Neurocognitive dysfunction, Hypertension, Sub-Saharan Africa, Protocol