A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa

Inclusion Criteria (for HIV-uninfected volunteers): * Willing to comply with the protocol and available for follow-up for the study duration * Has understood the information provided and has provided written informed consent before any study-related procedures are performed * Willing to undergo couple HIV testing, sexually transmitted infection (STI) screening, HIV counseling and receive test results, and share results with partner * At risk for HIV infection as defined by: has an HIV-infected partner not using ART in the past 3 months and had episodes of unprotected sex with partner in the past 3 months * If a female of childbearing potential: * using an effective method of non-barrier contraception (hormonal contraceptive * intrauterine device (IUD) * surgical sterility) from 7 days prior to randomization until the end of the study * all female volunteers must be willing to undergo urine pregnancy tests * HIV-infected partner is willing and eligible to enroll in the study Inclusion Criteria (for HIV-1 infected partner): * HIV-1 infected partner of an HIV-uninfected volunteer who meets study eligibility * Plan to remain in the relationship for the duration of the study period * Willing and able to provide written informed consent \& locator information Exclusion Criteria (for HIV-uninfected volunteer): * Confirmed HIV-1 or HIV-2 infection * Any clinically significant acute or chronic medical condition that is considered progressive, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse * Any of the following abnormal lab parameters: * Haemoglobin \< 9.0 g/dL * Creatinine clearance \<80mL/min, as calculated by Cockcroft-Gault equation * AST: \> 2.5 x ULN * ALT: \> 2.5 x ULN * Total bilirubin \> 1.5 x ULN * Serum amylase \> 1.5 x ULN * Serum phosphorus \< 2.4 mg/dL * Urinalysis: Two abnormal dipsticks showing any of the following: * blood = 2+ or more (not due to menses); * protein = 1+ or more * leucocytes = 2+ or more * glucose= 1+ or more * Confirmed diagnosis of chronic hepatitis B infection (HBsAg positive) * If female, pregnant or planning a pregnancy within 4 months after enrolment or lactating * Participation in another clinical study of a product currently, or within the 3 mo. prior to enrolment Exclusion Criteria (for HIV-1 infected partner): * Current use of antiretroviral therapy * Concurrent enrollment in another HIV treatment trial