Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

Inclusion Criteria: * Male sex (at birth) * HIV uninfected * Age having reached the local age of consent * High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months. * Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period * Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale * Certain laboratory values * A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment. * Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor. Inclusion Criteria for Open-Label Extension: * Participated in a randomized, placebo-controlled, PrEP trail * Has been unblinded * Has provided informed consent Exclusion Criteria: * Previously diagnosed active and serious infections, including tuberculosis infection, osteomyeli…