This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In recent years, a number of new laboratory-based strategies have been devised to classify individuals as recently infected or with established infection. The ability to differentiate youth with recent HIV infection from those youth with established HIV infection is important for increasing linkage to care, for behavioral counseling, and for enrolling individuals into programs such as the ATN that can provide effective interventions to influence disease progression and outcome. This is a cross-sectional laboratory-based study designed to develop and evaluate a saliva-based sensitive/less sensitive (S/LS) assay for differentiating individuals with recent HIV infection (less than 133 days) from those with established HIV infection. Serum and two saliva samples will be obtained from every subject, a small portion of the patient samples will be used to develop and calibrate the salvia-based S/LS method. The remaining patient samples will be tested using the calibrated saliva S/LS assay and the reference serum S/LS (DV S/LS) assay. Concordance between the two methods will be analyzed. For the sub-study, phenotypic and genotypic testing for antiretroviral (ART) drug resistance will be done on stored samples from all subjects who are identified as recently infected by the serum based DV S/LS reference method. An assay for viral replication fitness will also be done on these same samples. This testing will provide a recent assessment of prevalence of transmitted ART resistance HIV-1 in this population.
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