Discordant result visits
® HIV combi, ®
HIV INFECTION, EVENTS
Participants who have discordant results between (a) the POC HIV VL test or (b) the rapid HIV tests compared with the laboratory-based HIV tests will be offered additional study follow-up visits to evaluate the sensitivity of different HIV tests for detection of early HIV infection.The participants with discordant results will remain in the study until one of the following events occurs:
Participant tests reactive/positive for HIV for all tests being evaluated,Participant has two consecutive study visits with non-reactive/negative results for all tests (indicating that they had a prior false-reactive/positive result), orParticipant completes follow-up of 70 days after the enrollment visitThe follow-up schedule for those with discordant results will include return visits at Days 3, 7, 10, 14, 21, 28, 42, 56, and 70 post-enrollment visits. At each follow-up visit, participants will provide blood and oral fluid specimens for storage and testing along with the rapid HIV tests under evaluation (e.g., OraQuick ADVANCE® Rapid HIV-1/2 Antibody test, DPP® HIV-Syphilis System); other laboratory HIV diagnostics where applicable (Elecsys® HIV combi PT, Geenius™ HIV-1/2 Supplemental Assay), and the cobas® HIV-1 test (Table 