Quality of Sleep in HIV-Infection: Association with Treatment and Adherence

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Investigator: Parya Saberi, PharmD
Sponsor: NIH National Institute of Mental Health

Location(s): United States

Description

Treatment with antiretroviral (ARV) medications has substantially decreased mortality rates due to HIV illness and modified the clinical care of HIV-infected individuals from an acute to a chronic disease management. High rates of adherence to ARV regimens are required in order to achieve maximal efficacy and less than optimal adherence has been associated with decreased survival rates as well as increased risk of developing ARV-resistant strains. Factors associated with reduced adherence are complex, but a consistent finding in the literature as reason for non-adherence is adverse effects. Sleep disturbances are reported to be as high as 73% in HIV-infected subjects. Potential mechanisms of this effect include correlations with altered immune function, psychiatric illness, illicit drugs or alcohol use, and adverse effects of ARVs. Despite studies on sleep disturbances in HIV-positive individuals, little is known about the effect of ARVs on quality of sleep (QOS) and consequences of poor sleep on adherence. The primary aims of this proposal are to compare QOS in a cohort of HIV-infected subjects before and after ARV initiation and establish the effect of QOS on ARV adherence. The long-term objective of this research is to improve the care for HIV-infected individuals by shedding light on unexplored factors which may be associated with non-adherence and treatment failure. This fellowship will support the candidate's efforts in four studies as well as the completion of the Master's Degree in Clinical Research. The first two projects are secondary data analyses of two completed clinical trials, which will establish the effect of QOS on adherence and determine the effect of specific ARVs on QOS. The third study will be a prospective cohort study, nested into an R01-funded trial, and will compare the effect of ARV-initiation on QOS and compare QOS between subjects on efavirenz (EFV) versus non-EFV-based regimens. The fourth project is a qualitative QOS pilot study with the primary aim of exploring the association between HIV infection, ARV adverse effects, substance use, and depression with QOS of HIV-infected individuals. This proposal fits the agency's mission of "determine the relationship(s) among disease stage, individual difference characteristics, treatment response, and how adherence is related to treatment outcomes throughout the course of the treatment, illness, and interventions".

Non-adherence can result in increased risk of ARV-resistant virus transmission and exacerbation of the HIV epidemic due to decreased treatment options. The results of this study will benefit public health by helping to identify factors influencing adherence and by minimizing the sequelae of non-adherence.