Flow_Chart-Eligibility_Criteria_and_Populations_Attach_J-10.pdf

Part 3 – Intensive follow-up of persons with discordant test results

Total sample across sites ~200 including at least 50 early infections who complete follow-up

Part 2 – Evaluation of up to 7 novel HIV tests, identification of persons with discordant test results (at least one positive test but not all 7 positive)

Total sample across sites ~ 10,000 including a minimum of 600 HIV-infected and 50 early infections

Part 1 – Description of the overall population and limitation to the patients at highest risk for recent HIV infection

Total Sample across sites ~ 50,000

Provide risk information on entire patient population and HIV test results for the lower risk subset

Persons identified as lower risk in Part 1 who have a positive HIV test

Low-Risk persons with discordant test results in

Part 2

All persons classified as highest risk in Part 1

High risk persons with discordant test results in

Part 2 ycy1 Typewritten Text Attachment J-10