Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.

BACKGROUND

Chronic HIV infection commonly affects both cognition and mental health, even with excellent systemic viral control. The causes of compromised brain health are likely to be a multi-factorial combination of HIV-related biological factors, co-morbidities such as aging and cerebrovascular disease, and the erosion of coping skills, physical health, and social supports resulting from the strains of living with a chronic illness.

METHODS/DESIGN: This study aims to provide a better understanding of the relationship between cognitive complaints, depression, and objectively measured cognitive impairment in HIV, and of the key factors, whether biological or personal, which relate to these presentations and to their evolution over time. Characterization of this heterogeneity will permit more focused pathophysiological studies, and allow more targeted interventions. The project makes extensive use of Web-based research and health care delivery tools, aiming to provide cost-effective, "clinic ready" tools to improve brain health in HIV. This project has two overarching aims, reflecting our dual goals of understanding and improving brain health in HIV, focusing on cognitive impairment, its contributors and consequences. The objectives are to contribute evidence for the validity of a brief brain health assessment, to estimate the extent to which HIV-related cognition-relevant clinical factors and patient-centered outcomes inter-relate and evolve over time, allowing identification of the mechanisms underpinning longitudinal change in brain health and to contribute evidence for the feasibility, effectiveness potential, acceptability, and underlying mechanisms of promising interventions for optimizing brain health. We adopt a cohort multiple randomized control trials design. A total of 900 participants will be characterized prospectively over a 27-month period to answer questions about the evolution of outcomes of interest. All participants will be offered basic brain health self-management information. Sub-groups will participate in pilot studies of specific, more intensive interventions to provide pragmatic evidence for feasibility, effectiveness, and comparative effectiveness.

DISCUSSION

This work will provide needed estimates of the burden, heterogeneity, evolution, and mechanisms underlying compromised brain health in HIV, and test a range of promising non-pharmacological interventions. This is an on-going study; the trials nested within this cohort that are currently recruiting participants were registered on 7 October 2015 (Clinicaltrials.gov NCT02571504 and NCT02571595).