The purpose of this study is to establish a proof-of-concept for whether rapid test can detect viral rebounds that occurred within a retrospective time window among PLHIV receiving ART in the United States and sub-Saharan Africa. The objective of this study is to assess whether HIV antibody levels rise following HIV viral rebound, and the sensitivity and specificity of antibody level increases for detecting HIV viral rebounds. The investigators will conduct a retrospective matched case-control study of individuals with or without suppressed viral load on antiretroviral therapy (ART). Biobanked specimens will be tested for antibody levels.
Study Type
OBSERVATIONAL
Enrollment
6,100
NYU Langone Health
New York, New York, United States
Sensitivity of Antibody Level Changes
Sensitivity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2. Unsuppressed VL will be defined as VL \>500 copies/mL.
Time frame: Up to Month 26 (T3)
Specificity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2. Unsuppressed VL will be defined as VL \>500 copies/mL.
Time frame: Up to Month 26 (T3)
Sensitivity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2, defined as VL \>50 copies/mL versus \<=50 copies/mL.
Time frame: Up to Month 26 (T3)
Specificity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2, defined as VL \>50 copies/mL versus \<=50 copies/mL.
Time frame: Up to Month 26 (T3)
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