Characterizing Symptoms and Identifying Biomarkers of Long COVID in People With and Without HIV: Protocol for a Remotely Conducted Prospective Observational Cohort Study

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Published online 2023 May 31. doi: 10.2196/47079

Copyright/LicenseRequest permission to reuse: Copyright ©Nuria Gallego Márquez, Armaan Jamal, Rowena Johnston, E India Richter, Pamina M Gorbach, Tracy D Vannorsdall, Leah H Rubin, Cheryl Jennings, Alan L Landay, Michael J Peluso, Annukka A R Antar. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.05.2023.
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Table 1

Participant inclusion and exclusion criteria.

Criteria	HIV+COVID+ arm	HIV−COVID+ arm	HIV+COVID− arm	HIV−COVID− arm
Inclusion	Self-reported HIV infection Ability to furnish proof of SARS-CoV-2 infection or reasonable certainty that they had SARS-CoV-2 infection First COVID-19 symptoms or first positive diagnostic COVID-19 test (if asymptomatic) occurred within 28 days before enrollment	Self-reported HIV-negative status^a Ability to furnish proof of SARS-CoV-2 infection or reasonable certainty that they had SARS-CoV-2 infection First COVID-19 symptoms or first positive diagnostic COVID-19 test (if asymptomatic) occurred within 28 days before enrollment	Self-reported HIV infection Never tested positive for SARS-CoV-2 and does not believe they have ever had SARS-CoV-2 infection^b	Self-reported HIV-negative status^a Never tested positive for SARS-CoV-2 and does not believe they have ever had SARS-CoV-2 infectionb
Exclusion	A first or only diagnosis of SARS-CoV-2 infection >28 days before contact with study	A first or only diagnosis of SARS-CoV-2 infection >28 days before contact with study	Have tested positive for SARS-CoV-2 or believe that they have had SARS-CoV-2 infection at some point in the past regardless of whether they were tested	Have tested positive for SARS-CoV-2 or believe that they have had SARS-CoV-2 infection at some point in the past regardless of whether they were tested

^aHIV antigen and antibody test was performed on all participants in this group as part of the study to confirm HIV-seronegative status.

^bSARS-CoV-2 antinucleocapsid antibody testing was performed as part of this study and must be negative for inclusion in the analyses.