This supplement is appropriate for PA-18-591 and responsive to research areas requested in the NIDA supported NOSI on the 2019 Coronavirus (NOT-DA-20-047) including research to determine whether drug use is a risk factor for the onset/progression of COVID-19 (the disease caused by SARS-CoV-2), research on the onset and progression of COVID-19 and the impact of HIV and drug use; and research to understand the broad impacts of COVID-19 on drug use. This supplement leverages and expands the comprehensive data available in CNICS to better understand drug use and its impacts on COVID-19 and its complications among people living with HIV (PLWH) including the impact of drug use on rates of COVID-19 symptomatic disease and asymptomatic infection. We will examine the impact of drug use on poorer outcomes among those with symptomatic COVID-19 disease. Furthermore, we will examine the impact of the pandemic itself on all PLWH in CNICS including on drug use and access to harm reduction services. Specifically, we will: 1. Determine the incidence of clinically significant COVID-19-related illness and overall seroprevalence of SARS-CoV-2 infection among PLWH who use different types of inhaled drugs, smoke, and vape in comparison to PLWH who do not use substances. 2. Examine the association between drug use and severity of COVID-19-related illness including COVID-19 hospitalizations, ICU admissions, need for intubation, thrombotic complications, and mortality. 3. Determine one-year outcomes both among a) PLWH who develop COVID-19 including 1-year mortality, quality of life, HIV viral suppression, changes in drug and tobacco use, and whether outcomes differ by drug use and b) changes in the cohort overall including changes in drug use and engagement to harm reduction services, engagement in care, depression, and quality of life to better understand the impact of the pandemic and social isolation. We leverage the comprehensive clinical data and specimen biorepository of the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort. This includes COVID-19 diagnoses and laboratory testing from clinical care; a chart review validation approach that has been developed that confirms COVID- 19 diagnoses and captures information regarding course such as hospitalization, intensive care unit admission, intubation, and death; state-of-the-art phenotype measurement including adjudication for outcomes prevalent among PLWH who use drugs such as thrombotic events that may be occurring at high rates with COVID-19; as well as rich on-going substance use information including prior and current substance use, routes of use, and patterns and frequency of use. By combining rich CNICS data with antibody testing of a random sample of PLWH in CNICS to determine the underlying seroprevalence rates, we will be able to better understand both the incidence and likelihood of developing clinical disease among those positive for SARS-CoV-2 virus, and the course of COVID-19 and to do so by patterns of drug use.
Given the high morbidity and mortality, investigating risk factors for developing COVID-19, severe disease, or death is needed particularly among the potentially highest risk people living with HIV (PLWH) such as those who use drugs in order to guide testing and inform prevention and treatment strategies. In addition, a better understanding of the impact of the pandemic and social isolation is needed particularly for PLWH who use drugs where the impact on the HIV care cascade and other outcomes may be greater. We will examine risk factors particularly the role of drug use and clinical outcomes of COVID-19 disease and seroprevalence in a well-characterized, and diverse population of PLWH in routine clinical care across the U.S.
