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

Table 2 EPIC-NSW study flowchart

Follow-up schedule	Screening/enrolment/baseline	Follow-up 1	Subsequent Follow-ups
Timeline	Week −2 or 0^{a, b}	Month 1	Month 3 and every 3 months thereafter^c
Informed consent	X
Review eligibility	X	X	X
Medical history^d	X
Renal function (creatinine clearance)	X		X^e
Serious adverse events, pregnancy (if applicable)		X	X
Hepatitis C testing	X		X^f
STI testing ^g	X		X
HIV testing^g	X	X	X
Dispense study medication	X	X	X
Survey of adherence and behaviour	X		X^h

^aResults of all tests conducted in the preceding 2 weeks are accepted at enrolment. Only the HIV test should be conducted not earlier than 7 days within starting PrEP
^bVisits may be combined if HIV test result available
^cAs per NSW and National PrEP guidelines
^dInformation in relation to eligibility for PrEP
^eAt 3 months and every 6 months thereafter
^fConsider annual testing for HCV, or more often in men with substantial risk
^gHIV and STI tests conducted per current standard of care according to the National HIV and STI testing guidelines. Data obtained electronically quarterly from ACCESS study
^hBehavioural data collected on consenting participants

ISSN: 1471-2458