Enrollment visit
®, HIV, human immunodeficiency virus, HIV antibody tests- 20, human immunodeficiency virus, TATHIV, ® HIV combi
EVENTS, DISEASE, HUMAN IMMUNODEFICIENCY VIRUS
At the enrollment visit, study participants in both arms will provide blood and oral fluid specimens for HIV testing. The sequence for enrollment visit procedures is presented in Fig. 
OraQuick ADVANCEDPPElecsysGeenius
Sequence for enrollment visit procedures in the EHPOC study, Baltimore, MD, 2023–2024Abbreviations: CDC, Centers for Disease Control and Prevention; EDTA, Ethylenediamine Tetra acetic Acid; HIV, human immunodeficiency virus; mL, milliliter; SOC, standard-of-care; VL, viral load
HIV Laboratory and POC tests performed in the EHPOC study, Baltimore, MD, 2023–2024This test will be in addition to the SOC algorithm as an HIV screening test- 90 min TATHIV screening in the SOC algorithm- Variable TAT (mostly within 24 h)HIV confirmation in the SOC algorithm- Variable TAT (mostly within 24 h)HIV confirmation in the SOC algorithm and comparator to the Xpert® HIV-1 VL test- Variable TAT (mostly within 48 h)HIV screening and Comparison of rapid HIV antibody tests- 20 min TATHIV screening and Comparison of rapid HIV antibody tests- 20 min TATAbbreviations: Ag: antigen; Ab, antibodies; CA, California; HIV, human immunodeficiency virus; IN, Indiana; NY, New York; FDA: Food and Drug Administration; PA, Pennsylvania; RNA ribonucleic acid; SOC, standard-of-care; TAT, turnaround time; VL, viral load; WA, Washington.Oral fluid samples and plasma aliquots will be processed and frozen for storage in a biorepository for future HIV test evaluation purposes (Fig. 1).The SOC HIV testing algorithm will be performed at the Immunology Laboratory at JHH. The current SOC HIV testing algorithm consists of the following tests: a laboratory-based, instrumented, Elecsys® HIV combi PT (Roche Diagnostics, Indianapolis, IN), the Geenius™ HIV-1/2 Supplemental Assay (Bio-Rad Laboratories, Inc., Redman, WA), with reflex, when appropriate, to the cobas® HIV-1 test (Roche Molecular Systems, Inc, Pleasanton, CA) (See Table The study will collect participants’ demographic data, as well as sexual, and drug use behaviors. Additionally, their medical records will be examined to document physical exam findings.In addition to the procedures described previously, participants assigned to the intervention arm will be tested using a research use only POC HIV VL test (Xpert® HIV-1 VL) during the enrollment visit. This will be supplemented by the cobas® HIV-1 test, which will be available for clinical use (Table 
Schedule of events in the EHPOC study, Baltimore, MD, 2023–2024Abbreviations: Ab, antibody; Ag, antigen; C, Control arm; HIV, human immunodeficiency virus; I, Intervention arm; SOC, standard of care; POC, point-of-care1) Participants whose POC VL or rapid test result is discordant with laboratory-based test results will be offered additional study follow-up visits. The additional follow-up schedule will include return visits at Days 3, 7, 10, 14, 21, 28, 42, 56, and 70 after the enrollment visit. The participants with discordant results will remain in the study until one of the following events occurs:a) Participant tests reactive/positive for HIV for all tests being evaluated, orb) Participant has two consecutive study visits with non-reactive/negative results for all tests (indicating that they had a prior false-reactive/positive result)