Skip to main content

Table 3 Inclusion and exclusion criteria for participation in the EPIC-NSW study

From: Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial

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)