Inclusion criteria | Exclusion criteria |
---|---|
 1. HIV negative at enrolment, with a negative HIV test result documented within 7 days of initiating PrEP | 1. HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive status is not confirmed by testing, delay starting PrEP for at least 1 month and reconfirm negative HIV-1 status). |
 2. At high and ongoing risk for acquiring HIV infection through sexual exposure (as defined by Behavioural Eligibility criteria presented in Table 1) | 2. Having an estimated creatinine clearance (glomerular filtration rate [GFR]) <60 ml/min |
 3. Aged 18 years or over | 3. Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) |
 4. Live in NSW or visit NSW enough to attend clinics for follow-up assessments | 4. Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs) |
 5. Willing and able to provide informed consent | 5. Allergic to TDF and/or FTC (based on self-report or recorded) |
 6. Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient | 6. Concurrently taking prescribed products containing FTC or TDF other drugs containing lamivudine |
 | 7. Factors or conditions that may compromise a participant’s access to health services for follow-up (incarceration or planned relocation and potential absence from NSW for the duration of the study) |