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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biobanked specimens - Suppressed Viral Load | Biobanked specimens from individuals with suppressed viral load on antiretroviral therapy (ART). | ||
| Biobanked specimens - Unsupressed Viral Load | Biobanked specimens from individuals without suppressed viral load on antiretroviral therapy (ART). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to Month 26 (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Month 26 (T3) |
| Specificity of Antibody Level Changes |
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Inclusion Criteria:
HIV-positive individuals aged 15 or older at the time of ART initiation.
Participated in HIV plasma or serum biobanking and viral load testing, with three samples after January 1, 2015 as follows:
At least one VL measurement recorded prior to T1, with:
Exclusion Criteria:
Individuals with advanced HIV disease from 1 year prior to T1 until T3, defined as:
Individuals with severe illness or hospitalization from 1 year prior to T1 until T3.
Individuals with immune disorder or cancer diagnosis from 1 year prior to T1 until T3.
Individuals with known recent infection at time of ART initiation (ART initiated within 1 year of estimated date of detectable infection).
Individuals known to have been infected with HIV perinatally.
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Investigators will test biobanked samples from the following cohorts:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Bershteyn, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
This study will not enroll participants; a study site lab will test publicly available blood samples, and investigators will use their results to estimate sensitivity and specificity of the rapid tests to detect change in HIV antibodies.
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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. |
| Up to Month 26 (T3) |